Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-03-01 @ 11:38 PM
Study NCT ID:
NCT02547428
Status:
COMPLETED
Last Update Posted:
2021-11-11
First Post:
2015-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Centanafadine Sustained-Release (CTN SR) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltransparency@otsuka-us.com', 'phone': '+1-609-524-6788', 'title': 'Global Clinical Development', 'organization': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From signing of informed consent up to approximately Week 9', 'description': 'Safety Population consisted of all participants who were randomized and had taken any dose of investigational product in the Double-blind Crossover Phase. As prespecified in the protocol, data for safety is reported by the treatment group (CTN SR and placebo).', 'eventGroups': [{'id': 'EG000', 'title': 'CTN SR', 'description': "Participants received CTN SR tablets at a starting dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common TDD was 400 mg/day.", 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 63, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo for up to 3 weeks. Placebo was titrated in the same manner to protect the blind. The most common TDD was 400 mg/day.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 50, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Supraventricular Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrohea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoaesthesia Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aphthous Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Food Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Energy Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Feeling Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sluggishness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Infusion Site Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vessel Puncture Site Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vessel Puncture Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Choleithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Orthostatic Heart Rate Response Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hepatic Enzyme Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood Pressure Diastolic Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood Pressure Orthostatic Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood Thyroid Stimulating Hormone Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Heart Rate Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Liver Function Test Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lymph Node Palpable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood Lactate Dehydrogenase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood Pressure Systolic Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Increased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Polydipsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Poor Quality Sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mental Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tension Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinus Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Affect Lability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bruxism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Derealisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysphoria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abnormal Dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Apathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Emotional Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Jealous Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Libido Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pressure Of Speech', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Initial Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Middle Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Terminal Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinus Operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Infusion Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Attention-Deficit Hyperactivity Disorder Rating Scale IV (ADHD-RS-IV) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR', 'description': "Participants received CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common total daily dose TDD was 400 mg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo for up to 3 weeks. Placebo was titrated in the same manner to protect the blind. The most common TDD was 400 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.2', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '7.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.1', 'ciLowerLimit': '-11.0', 'ciUpperLimit': '-5.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.48', 'estimateComment': 'Sample size of 60 participants (30 per treatment sequence) was needed to provide minimum 85% power to detect 5 point difference between treatments at a 2-sided significance level of 5% using a paired t-test.', 'groupDescription': 'Null hypothesis was that there was no difference in ADHD-RS-IV total score change from Baseline between CTN SR and placebo. The analysis of covariance (ANCOVA) model included terms for period, sequence, and treatment as fixed effects, and Baseline score as a covariate, and a participate-within-sequence term as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 3', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Full Analysis Set (FAS) included all participants who were randomized and had at least one post-dose efficacy assessment. Number analyzed is the number of participants with data available for analyses at the given time-point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in ADHD-RS-IV Score for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablets daily for 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo daily for 3 weeks in treatment Periods 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.3', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '8.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.1', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '-3.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.74', 'groupDescription': 'Null hypothesis was that there was no difference in ADHD-RS-IV total score change from Baseline between CTN SR 400 mg/day and placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 3', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and had at least one post-dose efficacy assessment. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ADHD-RS-IV Score Total Score After 1 and 2 Weeks of Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR', 'description': "Participants received CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common total daily dose TDD was 400 mg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo for up to 3 weeks. Placebo was titrated in the same manner to protect the blind. The most common TDD was 400 mg/day.'}], 'classes': [{'title': 'Change from Baseline at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.0', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.4', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '7.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, and 2', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and had at least one post-dose efficacy assessment. Number analyzed is the number of participants with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ADHD-RS-IV Score Total Score After 1 and 2 Weeks of Double-blind Treatment for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablets daily for 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo daily for 3 weeks in treatment Periods 1 and 2.'}], 'classes': [{'title': 'Change from Baseline at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.0', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.0', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '8.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, and 2', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and had at least one post-dose efficacy assessment. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ADHD-RS-IV Inattention Subscale Score of Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR', 'description': "Participants received CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common total daily dose TDD was 400 mg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo for up to 3 weeks. Placebo was titrated in the same manner to protect the blind. The most common TDD was 400 mg/day.'}], 'classes': [{'title': 'Change from Baseline at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.2', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.3', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 2 and 3', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. The possible sub-scale score range is from 0 to 27. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and had at least one post-dose efficacy assessment. Number analyzed is the number of participants with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ADHD-RS-IV Inattention Subscale Score of Double-blind Treatment for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablets daily for 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo daily for 3 weeks in treatment Periods 1 and 2.'}], 'classes': [{'title': 'Change from Baseline at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.6', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.4', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.7', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 2 and 3', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. 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The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. The possible sub-scale score range is from 0 to 27. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and had at least one post-dose efficacy assessment. Number analyzed is the number of participants with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ADHD-RS-IV Hyperactivity/Impulsivity Subscale Score of Double-blind Treatment for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablets daily for 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo daily for 3 weeks in treatment Periods 1 and 2.'}], 'classes': [{'title': 'Change from Baseline at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.3', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.6', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.6', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 2 and 3', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. The possible sub-scale score range is from 0 to 27. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and had at least one post-dose efficacy assessment. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Permanent Product Measure of Performance (PERMP) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR', 'description': "Participants received CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common total daily dose TDD was 400 mg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo for up to 3 weeks. Placebo was titrated in the same manner to protect the blind. The most common TDD was 400 mg/day.'}], 'classes': [{'title': 'Total Score- 0.5 Hour Before Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '226.7', 'spread': '87.1', 'groupId': 'OG000'}, {'value': '232.7', 'spread': '90.9', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 1 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '238.7', 'spread': '90.4', 'groupId': 'OG000'}, {'value': '246.2', 'spread': '94.4', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 3 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '246.2', 'spread': '96.3', 'groupId': 'OG000'}, {'value': '242.6', 'spread': '94.4', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 5 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '244.5', 'spread': '92.2', 'groupId': 'OG000'}, {'value': '246.0', 'spread': '95.3', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 7 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '244.6', 'spread': '95.3', 'groupId': 'OG000'}, {'value': '245.8', 'spread': '100.1', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 9 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '246.6', 'spread': '91.1', 'groupId': 'OG000'}, {'value': '245.4', 'spread': '99.5', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 11 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '250.9', 'spread': '91.5', 'groupId': 'OG000'}, {'value': '244.9', 'spread': '104.5', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 13 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '250.7', 'spread': '93.5', 'groupId': 'OG000'}, {'value': '244.0', 'spread': '101.4', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 0.5 Hour Before Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115.3', 'spread': '43.5', 'groupId': 'OG000'}, {'value': '119.0', 'spread': '45.6', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 1 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121.3', 'spread': '45.3', 'groupId': 'OG000'}, {'value': '126.1', 'spread': '47.6', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 3 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124.9', 'spread': '48.3', 'groupId': 'OG000'}, {'value': '123.8', 'spread': '47.8', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 5 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124.2', 'spread': '46.4', 'groupId': 'OG000'}, {'value': '125.7', 'spread': '47.9', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 7 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124.2', 'spread': '47.9', 'groupId': 'OG000'}, {'value': '125.4', 'spread': '50.4', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 9 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '125.0', 'spread': '45.6', 'groupId': 'OG000'}, {'value': '125.2', 'spread': '50.1', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 11 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127.2', 'spread': '45.7', 'groupId': 'OG000'}, {'value': '124.2', 'spread': '52.5', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 13 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127.1', 'spread': '46.8', 'groupId': 'OG000'}, {'value': '124.0', 'spread': '51.0', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 0.5 Hour Before Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111.4', 'spread': '43.7', 'groupId': 'OG000'}, {'value': '113.7', 'spread': '45.8', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 1 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '117.3', 'spread': '45.2', 'groupId': 'OG000'}, {'value': '120.1', 'spread': '47.5', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 3 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121.3', 'spread': '48.1', 'groupId': 'OG000'}, {'value': '118.8', 'spread': '47.2', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 5 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120.3', 'spread': '45.9', 'groupId': 'OG000'}, {'value': '120.3', 'spread': '48.0', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 7 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120.4', 'spread': '47.5', 'groupId': 'OG000'}, {'value': '120.4', 'spread': '50.2', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 9 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121.6', 'spread': '45.6', 'groupId': 'OG000'}, {'value': '120.2', 'spread': '49.9', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 11 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '123.7', 'spread': '45.8', 'groupId': 'OG000'}, {'value': '120.6', 'spread': '52.1', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 13 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '123.6', 'spread': '46.8', 'groupId': 'OG000'}, {'value': '120.0', 'spread': '50.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose -0.5 hour and post-dose 1, 3, 5, 7, 9, 11 and 13 hours at Weeks 4 and 8', 'description': 'The Permanent Product Measure of Performance (PERMP) is a skill-adjusted math test consisting of 400 problems. The PERMP total score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The score range of number of math problems attempted and number of math problems answered correctly is 0-400 and the total score range from 0-800. The higher scores indicate better performance. Higher scores mean higher performance and less severe ADHD symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and had at least one post-dose efficacy assessment. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'PERMP Score for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablets daily for 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo daily for 3 weeks in treatment Periods 1 and 2.'}], 'classes': [{'title': 'Total Score- 0.5 Hour Before Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '226.8', 'spread': '81.4', 'groupId': 'OG000'}, {'value': '229.1', 'spread': '88.4', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 1 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '241.5', 'spread': '82.1', 'groupId': 'OG000'}, {'value': '242.6', 'spread': '89.1', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 3 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '249.8', 'spread': '90.0', 'groupId': 'OG000'}, {'value': '240.4', 'spread': '94.4', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 5 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '248.8', 'spread': '88.0', 'groupId': 'OG000'}, {'value': '241.0', 'spread': '95.3', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 7 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '249.7', 'spread': '96.2', 'groupId': 'OG000'}, {'value': '245.6', 'spread': '96.6', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 9 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '249.5', 'spread': '88.7', 'groupId': 'OG000'}, {'value': '246.2', 'spread': '98.9', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 11 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '253.5', 'spread': '91.8', 'groupId': 'OG000'}, {'value': '246.1', 'spread': '102.4', 'groupId': 'OG001'}]}]}, {'title': 'Total Score- 13 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '257.5', 'spread': '96.9', 'groupId': 'OG000'}, {'value': '248.6', 'spread': '96.5', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 0.5 Hour Before Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115.4', 'spread': '40.6', 'groupId': 'OG000'}, {'value': '116.6', 'spread': '44.2', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 1 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.9', 'spread': '40.9', 'groupId': 'OG000'}, {'value': '123.4', 'spread': '44.8', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 3 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127.0', 'spread': '45.0', 'groupId': 'OG000'}, {'value': '122.2', 'spread': '47.8', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 5 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126.4', 'spread': '44.2', 'groupId': 'OG000'}, {'value': '122.5', 'spread': '47.6', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 7 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126.9', 'spread': '48.2', 'groupId': 'OG000'}, {'value': '124.6', 'spread': '48.5', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 9 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126.6', 'spread': '44.3', 'groupId': 'OG000'}, {'value': '125.0', 'spread': '49.4', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 11 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128.6', 'spread': '45.8', 'groupId': 'OG000'}, {'value': '124.6', 'spread': '51.2', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Attempted- 13 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.4', 'spread': '48.5', 'groupId': 'OG000'}, {'value': '126.1', 'spread': '48.4', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 0.5 Hour Before Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111.4', 'spread': '41.0', 'groupId': 'OG000'}, {'value': '112.6', 'spread': '44.3', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 1 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118.6', 'spread': '41.3', 'groupId': 'OG000'}, {'value': '119.2', 'spread': '44.4', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 3 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.9', 'spread': '45.1', 'groupId': 'OG000'}, {'value': '118.3', 'spread': '46.7', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 5 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.4', 'spread': '43.9', 'groupId': 'OG000'}, {'value': '118.6', 'spread': '47.8', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 7 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.9', 'spread': '48.0', 'groupId': 'OG000'}, {'value': '121.0', 'spread': '48.2', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 9 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.9', 'spread': '44.5', 'groupId': 'OG000'}, {'value': '121.2', 'spread': '49.6', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 11 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124.9', 'spread': '46.1', 'groupId': 'OG000'}, {'value': '121.5', 'spread': '51.3', 'groupId': 'OG001'}]}]}, {'title': 'Number of Math Problems Answered Correctly- 13 Hour After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127.1', 'spread': '48.5', 'groupId': 'OG000'}, {'value': '122.5', 'spread': '48.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose -0.5 hour and post-dose 1, 3, 5, 7, 9, 11 and 13 hours at Weeks 4 and 8', 'description': 'The PERMP is a skill-adjusted math test consisting of 400 problems. The PERMP total score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The score range of number of math problems attempted and number of math problems answered correctly is 0-400 and the total score range from 0-800. The higher scores indicate better performance. Higher scores mean higher performance and less severe ADHD symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and had at least one post-dose efficacy assessment. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Global Impressions of Severity (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR First, Then Placebo', 'description': "Participants received CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 1. The dose was decreased based on safety and tolerability based on Investigator's discretion, followed by a washout Period of 1 week followed by matching-placebo for up to 3 weeks in Period 2. The most common TDD was 400 mg/day."}, {'id': 'OG001', 'title': 'Placebo First, Then CTN SR', 'description': "Participants received matching-placebo for up to 3 weeks in Period 1, followed by a washout Period of 1 week, followed by CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 2. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common TDD was 400 mg/day."}], 'classes': [{'title': 'Moderately ill', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Markedly ill', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Severely ill', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': "The CGI-S is performed to rate the severity of a participant's condition on a 8- point scale ranging from 0 to 7 where 0=not assessed, 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7 = among the most extremely ill participants.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and had at least one post-dose efficacy assessment. The data is reported as per the crossover dose received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Global Impressions of Improvement (CGI-I) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR', 'description': "Participants received CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common total daily dose TDD was 400 mg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo for up to 3 weeks. Placebo was titrated in the same manner to protect the blind. The most common TDD was 400 mg/day.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Score 1', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Score 3', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Score 4', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Score 5', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 6', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 7', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Score 1', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Score 3', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Score 4', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Score 5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Score 6', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 7', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Score 1', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Score 3', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Score 4', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Score 5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 6', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 7', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 1, 2, and 3', 'description': "The CGI-I permits a global evaluation of the participant's improvement over time. The CGI-I is a 8-point scale ranging from 0 to 7 where 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse and 7=very much worse. The CGI-I is completed by the clinician and assesses the participant's improvement relative to the symptoms at Baseline.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and had at least one post-dose efficacy assessment. Number analyzed is the number of participants with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CGI-I Score for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablets daily for 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo daily for 3 weeks in treatment Periods 1 and 2.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Score 1', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Score 3', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Score 4', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Score 5', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 6', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 7', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Score 1', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Score 3', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Score 4', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Score 5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 6', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 7', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Score 1', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Score 3', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Score 4', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Score 5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 6', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 7', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 1, 2, and 3', 'description': "The CGI-I permits a global evaluation of the participant's improvement over time. The CGI-I is a 8-point scale ranging from 0 to 7 where 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse and 7=very much worse. The CGI-I is completed by the clinician and assesses the participant's improvement relative to the symptoms at Baseline.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and had at least one post-dose efficacy assessment. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR', 'description': "Participants received CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common total daily dose TDD was 400 mg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo for up to 3 weeks. Placebo was titrated in the same manner to protect the blind. The most common TDD was 400 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From signing of informed consent up to approximately Week 9', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any AE with onset post study drug treatment in the two crossover treatment periods. As prespecified in the protocol, data for safety is reported by the treatment group (CTN SR and placebo).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were randomized and had taken any dose of investigational product (including placebo) in the Double-blind Crossover Phase.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One TEAEs for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablets daily for 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching-placebo daily for 3 weeks in treatment Periods 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From signing of informed consent up to approximately Week 9', 'description': 'An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any AE with onset post study drug treatment in the two crossover treatment periods. As prespecified in the protocol, data for safety is reported by the treatment group (CTN SR and placebo).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were randomized and had taken any dose of investigational product (including placebo) in the Double-blind Crossover Phase. Overall number analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 300 mg', 'description': 'Participants received CTN SR 300 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG002', 'title': 'CTN SR 600 mg', 'description': 'Participants received CTN SR 600 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '1450', 'spread': '461', 'groupId': 'OG000'}, {'value': '1460', 'spread': '570', 'groupId': 'OG001'}, {'value': '3080', 'spread': '2260', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8', 'unitOfMeasure': 'nanograms per milliliter (ng/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set included all participants in the Safety Population who have post-dose drug concentration data available for analysis. Overall number analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time to Maximum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 300 mg', 'description': 'Participants received CTN SR 300 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG002', 'title': 'CTN SR 600 mg', 'description': 'Participants received CTN SR 600 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.36', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '6.48'}, {'value': '8.10', 'groupId': 'OG001', 'lowerLimit': '1.95', 'upperLimit': '12.0'}, {'value': '8.12', 'groupId': 'OG002', 'lowerLimit': '1.72', 'upperLimit': '11.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set included all participants in the Safety Population who have post-dose drug concentration data available for analysis. Overall number analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 'AUC0-t: Area Under the Concentration-Time Curve During the Steady-State 24-hour Dosing Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 300 mg', 'description': 'Participants received CTN SR 300 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG002', 'title': 'CTN SR 600 mg', 'description': 'Participants received CTN SR 600 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '14700', 'spread': '5180', 'groupId': 'OG000'}, {'value': '16900', 'spread': '5970', 'groupId': 'OG001'}, {'value': '34300', 'spread': '23600', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8', 'unitOfMeasure': 'hours*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set included all participants in the Safety Population who have post-dose drug concentration data available for analysis. Overall number analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 't½: Elimination Phase Half-Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 300 mg', 'description': 'Participants received CTN SR 300 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG002', 'title': 'CTN SR 600 mg', 'description': 'Participants received CTN SR 600 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.53', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '5.08', 'spread': '2.88', 'groupId': 'OG001'}, {'value': '4.06', 'spread': '1.89', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set included all participants in the Safety Population who have post-dose drug concentration data available for analysis. Overall number analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 'Clast: Last Measurable Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 300 mg', 'description': 'Participants received CTN SR 300 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG002', 'title': 'CTN SR 600 mg', 'description': 'Participants received CTN SR 600 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}], 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8', 'reportingStatus': 'POSTED', 'populationDescription': 'All efforts have been exhausted to locate this data and it has since been destroyed, therefore no data is available to report for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Tlast: Time Point of the Last Measurable Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 300 mg', 'description': 'Participants received CTN SR 300 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG002', 'title': 'CTN SR 600 mg', 'description': 'Participants received CTN SR 600 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}], 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8', 'reportingStatus': 'POSTED', 'populationDescription': 'All efforts have been exhausted to locate this data and it has since been destroyed, therefore no data is available to report for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'ke: Elimination Phase Rate Constant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CTN SR 300 mg', 'description': 'Participants received CTN SR 300 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG001', 'title': 'CTN SR 400 mg', 'description': 'Participants received CTN SR 400 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}, {'id': 'OG002', 'title': 'CTN SR 600 mg', 'description': 'Participants received CTN SR 600 mg tablet for up to 3 weeks in treatment Periods 1 and 2.'}], 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8', 'reportingStatus': 'POSTED', 'populationDescription': 'All efforts have been exhausted to locate this data and it has since been destroyed, therefore no data is available to report for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CTN SR First, Then Placebo', 'description': "Participants received CTN SR tablets starting at a dose of 100 or 200 milligrams (mg) on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 1. The dose was decreased based on safety and tolerability based on Investigator's discretion, followed by a washout Period of 1 week followed by matching-placebo for up to 3 weeks in Period 2. The most common total daily dose (TDD) was 400 mg/day."}, {'id': 'FG001', 'title': 'Placebo First, Then CTN SR', 'description': "Participants received matching-placebo for up to 3 weeks in Period 1, followed by a washout Period of 1 week, followed by CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 2. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common TDD was 400 mg/day."}], 'periods': [{'title': 'Period 1- Treatment Sequence 1 (3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Dosing Suspension', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Period 2- Treatment Sequence 2 (3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Investigator Discretion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 4 sites in United States from 03 Aug 2015 to 4 Jun 2016.', 'preAssignmentDetails': 'A total of 85 participants were enrolled in this study. Participants were randomly assigned to 1 of 2 treatment sequences to receive Centanafadine sustained-release (CTN SR) or placebo in sequence 1, followed by washout, followed by crossover treatment with placebo or CTN SR in sequence 2, with each treatment sequence lasting 3 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CTN SR First, Then Placebo', 'description': "Participants received CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 1. The dose was decreased based on safety and tolerability based on Investigator's discretion, followed by a washout Period of 1 week followed by matching-placebo for up to 3 weeks in Period 2. The most common TDD was 400 mg/day."}, {'id': 'BG001', 'title': 'Placebo First, Then CTN SR', 'description': "Participants received matching-placebo for up to 3 weeks in Period 1, followed by a washout Period of 1 week, followed by CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 2. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common TDD was 400 mg/day."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.2', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '36.5', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '35.4', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized and had at least one post-dose efficacy assessment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'dispFirstSubmitDate': '2019-07-10', 'completionDateStruct': {'date': '2016-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2015-09-08', 'dispFirstSubmitQcDate': '2019-07-10', 'resultsFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2015-09-09', 'dispFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-14', 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Attention-Deficit Hyperactivity Disorder Rating Scale IV (ADHD-RS-IV) Score', 'timeFrame': 'Baseline and Week 3', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in ADHD-RS-IV Score for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'timeFrame': 'Baseline and Week 3', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in ADHD-RS-IV Score Total Score After 1 and 2 Weeks of Double-blind Treatment', 'timeFrame': 'Baseline, Weeks 1, and 2', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in ADHD-RS-IV Score Total Score After 1 and 2 Weeks of Double-blind Treatment for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'timeFrame': 'Baseline, Weeks 1, and 2', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in ADHD-RS-IV Inattention Subscale Score of Double-blind Treatment', 'timeFrame': 'Baseline, Weeks 1, 2 and 3', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. The possible sub-scale score range is from 0 to 27. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in ADHD-RS-IV Inattention Subscale Score of Double-blind Treatment for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'timeFrame': 'Baseline, Weeks 1, 2 and 3', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. The possible sub-scale score range is from 0 to 27. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in ADHD-RS-IV Hyperactivity/Impulsivity Subscale Score of Double-blind Treatment', 'timeFrame': 'Baseline, Weeks 1, 2 and 3', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. The possible sub-scale score range is from 0 to 27. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in ADHD-RS-IV Hyperactivity/Impulsivity Subscale Score of Double-blind Treatment for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'timeFrame': 'Baseline, Weeks 1, 2 and 3', 'description': "The ADHD-RS-IV consists of 18 items and is designed to reflect the participant's current ADHD symptomatology; the severity, frequency, and impairment are measured for each of the items. The 18 items are grouped into 2 subscales of 9 symptoms each: Hyperactivity/Impulsivity (even numbered items 2-18) and Inattentiveness (odd numbered items 1-17). Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. The possible sub-scale score range is from 0 to 27. Higher scores indicate more severe disease. A negative change from Baseline indicates improvement."}, {'measure': 'Permanent Product Measure of Performance (PERMP) Score', 'timeFrame': 'Predose -0.5 hour and post-dose 1, 3, 5, 7, 9, 11 and 13 hours at Weeks 4 and 8', 'description': 'The Permanent Product Measure of Performance (PERMP) is a skill-adjusted math test consisting of 400 problems. The PERMP total score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The score range of number of math problems attempted and number of math problems answered correctly is 0-400 and the total score range from 0-800. The higher scores indicate better performance. Higher scores mean higher performance and less severe ADHD symptoms.'}, {'measure': 'PERMP Score for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'timeFrame': 'Predose -0.5 hour and post-dose 1, 3, 5, 7, 9, 11 and 13 hours at Weeks 4 and 8', 'description': 'The PERMP is a skill-adjusted math test consisting of 400 problems. The PERMP total score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The score range of number of math problems attempted and number of math problems answered correctly is 0-400 and the total score range from 0-800. The higher scores indicate better performance. Higher scores mean higher performance and less severe ADHD symptoms.'}, {'measure': 'Number of Participants With Clinical Global Impressions of Severity (CGI-S) Score', 'timeFrame': 'Baseline', 'description': "The CGI-S is performed to rate the severity of a participant's condition on a 8- point scale ranging from 0 to 7 where 0=not assessed, 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7 = among the most extremely ill participants."}, {'measure': 'Number of Participants With Clinical Global Impressions of Improvement (CGI-I) Score', 'timeFrame': 'Weeks 1, 2, and 3', 'description': "The CGI-I permits a global evaluation of the participant's improvement over time. The CGI-I is a 8-point scale ranging from 0 to 7 where 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse and 7=very much worse. The CGI-I is completed by the clinician and assesses the participant's improvement relative to the symptoms at Baseline."}, {'measure': 'Number of Participants With CGI-I Score for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'timeFrame': 'Weeks 1, 2, and 3', 'description': "The CGI-I permits a global evaluation of the participant's improvement over time. The CGI-I is a 8-point scale ranging from 0 to 7 where 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse and 7=very much worse. The CGI-I is completed by the clinician and assesses the participant's improvement relative to the symptoms at Baseline."}, {'measure': 'Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From signing of informed consent up to approximately Week 9', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any AE with onset post study drug treatment in the two crossover treatment periods. As prespecified in the protocol, data for safety is reported by the treatment group (CTN SR and placebo).'}, {'measure': 'Number of Participants With at Least One TEAEs for Subgroup of Participants With Target CTN SR Dose of 400 mg/Day', 'timeFrame': 'From signing of informed consent up to approximately Week 9', 'description': 'An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any AE with onset post study drug treatment in the two crossover treatment periods. As prespecified in the protocol, data for safety is reported by the treatment group (CTN SR and placebo).'}, {'measure': 'Cmax: Maximum Concentration', 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8'}, {'measure': 'Tmax: Time to Maximum Concentration', 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8'}, {'measure': 'AUC0-t: Area Under the Concentration-Time Curve During the Steady-State 24-hour Dosing Interval', 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8'}, {'measure': 't½: Elimination Phase Half-Life', 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8'}, {'measure': 'Clast: Last Measurable Concentration', 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8'}, {'measure': 'Tlast: Time Point of the Last Measurable Concentration', 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8'}, {'measure': 'ke: Elimination Phase Rate Constant', 'timeFrame': 'Predose 90 minutes and 2, 4, 6, 8,10, 11 to 12 and 24 hours post-dose at Weeks 4 and 8'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['centanafadine sustained-release', 'Attention-Deficit Hyperactivity Disorder'], 'conditions': ['Attention Deficit Disorder With Hyperactivity']}, 'descriptionModule': {'briefSummary': 'This was a Phase 2b, randomized, double-blind, multicenter, 2-period, 2-treatment, crossover study to evaluate safety and efficacy of CTN SR compared with placebo in adults with ADHD. Efficacy was also evaluated in the subgroup of adults with ADHD treated with a target CTN SR dose of 400 mg/day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participant was 18 to 60 years of age, inclusive, at the time of consent.\n2. Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD, defined as, established by a comprehensive psychiatric evaluation based on DSM-5 criteria with at least 5 of the 9 subtype criteria met, as determined by the Conners' Adult ADHD Diagnostic Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-4). Note: DSM-5 was used for screening / diagnosis and DSM-4 was used for evaluation throughout the study.\n3. Participant had a Baseline score of greater than or equal to 28 using the Attention-Deficit Hyperactivity Disorder Rating Scale IV (ADHD-RS-IV).\n4. Participant had a minimum score of 4 on the Clinical Global Impression of Severity at Baseline.\n5. Participant was functioning at an age-appropriate level intellectually, as judged by the Investigator.\n\nExclusion Criteria:\n\n1. Participant had a current comorbid psychiatric disorder that was either controlled with medications prohibited in this study or was uncontrolled and associated with significant symptoms. Exclusionary conditions included any severe comorbid Axis II disorder or severe Axis I disorder (such as post-traumatic stress disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations that, in the opinion of the examining physician, would have contraindicated CTN SR treatment or confound efficacy or safety assessments. Specifically, participants with mild to moderate forms of Axis I disorders (for example, social phobia and dysthymia) may have been included, whereas participants with a lifetime history of psychosis or bipolar disorder were excluded. Comorbid psychiatric diagnosis was established by a Semi-Structured Clinical Interview for DSM-5 Axis I Disorders (the Mini lnternational Neuropsychiatric lnterview, Version 6.0 \\[M.I.N.I. 6.0\\]).\n2. Participants who were currently considered a suicide risk, any participant who had previously made a suicide attempt, or those who were currently demonstrating active suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening, or if in the opinion of the investigator the participant was considered a suicide risk. Participants who developed suicidal ideation or behavior during the study as measured by the C-SSRS were discontinued and followed appropriately.\n3. The participant had a body mass index of less than 18.5 or greater than or equal to 40 at Baseline.\n4. Participant had a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might have confounded the results of safety assessments administered in the study or that might have increased risk to the participant.\n5. Participant had a history of seizures (other than infantile febrile seizures), any tic disorder (except transient tic disorder and participant had no episodes greater than or equal to 1 year), or a current diagnosis and/or a known family history of Tourette's Disorder (that is, first degree relatives).\n6. Participant had a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may have placed them at increased vulnerability to potential sympathomimetic effects.\n7. Participant had a known family history of sudden cardiac death or ventricular arrhythmia.\n8. Participant had a history of significant bleeding or coagulation disorder and/or low platelet levels (less than 130 x 10\\^9/liter) or increased international normalized ratio (greater than 1.3) at Screening.\n9. Participant had a history of cancer (other than noncomplicated basal or squamous cell cancer).\n10. Participant had any clinically significant 12-lead electrocardiogram or clinically significant laboratory abnormality at Screening and/or Baseline.\n11. Participant had current abnormal thyroid function, as defined as abnormal Screening thyroid stimulating hormone (less than 0.34 or greater than 5.6 micro-International Units/milliliter). Treatment with a stable dose of thyroid medication for at least 3 months was permitted.\n12. Participant had a resting sitting systolic blood pressure (SBP) greater than or equal to 140 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) greater than or equal to 90 mm Hg. No more than 1 repeat measurement was permitted.\n13. Participant had a history of hyponatremia.\n14. Participant was on an antihypertensive medication of any kind.\n15. Participant has a known history of orthostatic hypotension or has an orthostatic blood pressure drop of greater than or equal to 20 mm Hg (based on the drop between sitting and standing \\[3 minutes\\] SBP) at Screening or Baseline.\n16. Participant had a known history of hypertension.\n17. Participant exhibited lifestyle that may have been confounding to safety or efficacy assessments per the judgment of the investigator (for example, exercises, diets or travels extensively).\n18. Participant had a known history of glaucoma.\n19. Participant had failed to respond to 1 or more adequate courses (for example, adequate dose and duration with poor response as judged by the Investigator) of stimulant therapy.\n20. Participant had a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-5 criteria.\n21. Participant was taking other medications that have central nervous system effects or affected performance, such as sedating antihistamines and decongestant sympathomimetic, or was recently on monoamine oxidase inhibitors (during or within 14 days of investigational product administration). Stable use of bronchodilator inhalers was not exclusionary. This also included use of any psychoactive prescription medication 30 days prior to Screening or psychoactive over-the-counter ) medication or herbal products that required more than a 7-day washout. Participants currently treated with methylphenidate or amphetamine products were permitted and underwent a 7-day washout period. Participants who had taken atomoxetine were required to undergo a 30-day washout.\n22. Participant required the frequent or regular use of aspirin, ibuprofen, and naproxen sodium, or is on any anticoagulant, such as warfarin.\n23. Participant was taking known potent inhibitors or inducers of common cytochrome P450 enzymes, including herbal products.\n24. Participant had a positive urine drug screen (UDS) result at Screening or Baseline. Note: The UDS must be negative at Screening (with the exception of the participant's current ADHD psychostimulant, if applicable) or Baseline, if applicable, for the participant to potentially have been eligible for study participation. The Investigator, in conjunction with the Medical Monitor, evaluated the potential impact of a positive UDS regarding the continued participation of the participant.\n25. Participant had taken an investigational product or taken part in a clinical study within 30 days prior to Screening.\n26. Investigational site personnel were not permitted to participate in the study.\n27. Participant had participated previously in a CTN investigational study.\n28. The female participant was pregnant or lactating.\n29. Participant had a documented allergy, hypersensitivity, or intolerance to CTN or to any excipients in the reference product.\n30. Participant had a history of allergy or hypersensitivity to medications (for example., monoamine reuptake inhibitors or antibiotics).\n31. Participant did not agree to or was unable to abstain from consuming alcohol during the study.\n\n Reproductive Potential Requirements\n32. All female participants were required to have a negative serum beta human chorionic gonadotropin pregnancy test at Screening, a negative urine pregnancy test at Baseline, and be either postmenopausal (12 consecutive months of spontaneous amenorrhea and greater than or equal to 51 years of age), surgically sterile and at least 6 weeks post-sterilization or, for females of childbearing potential, had a negative pregnancy test prior to entering the study and agreed to use acceptable methods of contraception.\n\n Contraceptive Requirements\n33. Condoms were to be used with all forms of contraception (that is., double-barrier method). Acceptable contraceptives included the following:\n\n 1. Intrauterine devices\n 2. Hormonal contraceptives (oral, depot, patch, injectable, or vaginal ring)\n 3. Diaphragms with spermicidal gel or foam\n34. Females of childbearing potential were advised to use acceptable contraceptives from the date of informed consent throughout the study period and for the defined follow-up period.\n35. If hormonal contraceptives were used, they were to be administered according to the package insert.\n36. Females of childbearing potential who were not currently sexually active agreed to use acceptable contraception, as defined above, if they became sexually active during their study participation and for the defined follow-up time period."}, 'identificationModule': {'nctId': 'NCT02547428', 'briefTitle': 'Safety and Efficacy Study of Centanafadine Sustained-Release (CTN SR) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Crossover, Safety and Efficacy Study of Centanafadine Sustained-Release (CTN SR) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': 'NVI-EB-1020-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CTN SR First, Then Placebo', 'description': "Participants received CTN SR tablets starting at a dose of 100 or 200 milligrams (mg) on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 1. The dose was decreased based on safety and tolerability based on Investigator's discretion, followed by a washout Period of 1 week followed by matching-placebo for up to 3 weeks in Period 2. The most common total daily dose (TDD) was 400 mg/day.", 'interventionNames': ['Drug: CTN SR', 'Drug: Matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo First, Then CTN SR', 'description': "Participants received matching-placebo for up to 3 weeks in Period 1, followed by a washout Period of 1 week, followed by CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 2. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common TDD was 400 mg/day.", 'interventionNames': ['Drug: CTN SR', 'Drug: Matching placebo']}], 'interventions': [{'name': 'CTN SR', 'type': 'DRUG', 'otherNames': ['Centanafadine Sustained-Release'], 'description': 'CTN SR tablets, daily, Orally.', 'armGroupLabels': ['CTN SR First, Then Placebo', 'Placebo First, Then CTN SR']}, {'name': 'Matching placebo', 'type': 'DRUG', 'description': 'Matching-placebo tablets daily, orally.', 'armGroupLabels': ['CTN SR First, Then Placebo', 'Placebo First, Then CTN SR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '34201', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}]}, 'ipdSharingStatementModule': {'url': 'https://clinical-trials.otsuka.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.', 'ipdSharing': 'YES', 'description': 'Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.', 'accessCriteria': 'Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}