Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT01654250
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2012-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
NWP09 in Children 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': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (OL Phase; DB Phase)', 'description': 'Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \\[mg\\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.', 'otherNumAtRisk': 44, 'otherNumAffected': 31, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NWP09 (OL Phase; DB Phase)', 'description': 'NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.', 'otherNumAtRisk': 42, 'otherNumAffected': 33, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mood swings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Middle insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Change in sustained attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Emotional poverty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Onychophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Streptococcal impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Burns first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Conjunctival abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nail injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Snake bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Subcutaneous haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Allergic bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Excessive eye blinking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood pressure systolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Enuresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (OL Phase; DB Phase)', 'description': 'Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \\[mg\\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}, {'id': 'OG001', 'title': 'NWP09 (OL Phase; DB Phase)', 'description': 'NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '1.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square(LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.0', 'ciLowerLimit': '-10.9', 'ciUpperLimit': '-3.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.99', 'groupDescription': 'Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point, and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.75 up to 13 hours post-dose', 'description': "The SKAMP scale measured the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment. Average of all post dose SKAMP-combined scores measured at 0.75, 2, 4, 8, 10, 12 and 13 hours post-dose was calculated.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.'}, {'type': 'SECONDARY', 'title': 'Onset and Duration of Clinical Effect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (OL Phase; DB Phase)', 'description': 'Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \\[mg\\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}, {'id': 'OG001', 'title': 'NWP09 (OL Phase; DB Phase)', 'description': 'NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}], 'classes': [{'title': 'Hour 0.75', 'categories': [{'measurements': [{'value': '18.3', 'spread': '11.21', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '9.79', 'groupId': 'OG001'}]}]}, {'title': 'Hour 2', 'categories': [{'measurements': [{'value': '20.3', 'spread': '13.11', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '6.88', 'groupId': 'OG001'}]}]}, {'title': 'Hour 4', 'categories': [{'measurements': [{'value': '19.8', 'spread': '12.99', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '6.74', 'groupId': 'OG001'}]}]}, {'title': 'Hour 8', 'categories': [{'measurements': [{'value': '19.3', 'spread': '11.34', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '10.38', 'groupId': 'OG001'}]}]}, {'title': 'Hour 10', 'categories': [{'measurements': [{'value': '17.7', 'spread': '11.58', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '10.26', 'groupId': 'OG001'}]}]}, {'title': 'Hour 12', 'categories': [{'measurements': [{'value': '19.4', 'spread': '11.23', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '12.79', 'groupId': 'OG001'}]}]}, {'title': 'Hour 13', 'categories': [{'measurements': [{'value': '18.4', 'spread': '10.73', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '13.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.2', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '-3.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.28', 'groupDescription': 'Hour 0.75 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Hour 0.75 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.8', 'ciLowerLimit': '-17.3', 'ciUpperLimit': '-8.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.28', 'groupDescription': 'Hour 2 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Hour 2 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.3', 'ciLowerLimit': '-16.8', 'ciUpperLimit': '-7.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.28', 'groupDescription': 'Hour 4 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Hour 4 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.8', 'ciLowerLimit': '-12.3', 'ciUpperLimit': '-3.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.28', 'groupDescription': 'Hour 8 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effect and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Hour 8 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.28', 'groupDescription': 'Hour 10 post-dose: Nominal p-value -treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Hour 10 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.206', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '1.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.28', 'groupDescription': 'Hour 12 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Hour 12 post-dose: Adjusted p-values are generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.496', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '2.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.28', 'groupDescription': 'Hour 13 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Hour 13 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.75, 2, 4, 8, 10, 12, 13 hours post-dose', 'description': "Onset and duration of clinical effect was determined using SKAMP combined rating scale at each post-dose time point. Onset of effect was defined as first assessment time showing statistical significance (i.e. p was less than or equal to \\[=\\<\\] 0.05) between NWP09 and placebo and duration of effect was defined as the as last consecutive time-point at which difference was statistically significant between NWP09 and placebo. SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score was comprised of 13 items \\[subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)\\]. SKAMP combined score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.'}, {'type': 'SECONDARY', 'title': 'Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (OL Phase; DB Phase)', 'description': 'Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \\[mg\\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}, {'id': 'OG001', 'title': 'NWP09 (OL Phase; DB Phase)', 'description': 'NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}], 'classes': [{'title': 'Hour 0.75: Attention Subscale', 'categories': [{'measurements': [{'value': '2.9', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '2.35', 'groupId': 'OG001'}]}]}, {'title': 'Hour 0.75: Deportment Subscale', 'categories': [{'measurements': [{'value': '4.6', 'spread': '4.91', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '3.74', 'groupId': 'OG001'}]}]}, {'title': 'Hour 2: Attention Subscale', 'categories': [{'measurements': [{'value': '3.4', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.85', 'groupId': 'OG001'}]}]}, {'title': 'Hour 2: Deportment Subscale', 'categories': [{'measurements': [{'value': '5.4', 'spread': '5.31', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '2.43', 'groupId': 'OG001'}]}]}, {'title': 'Hour 4: Attention Subscale', 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.92', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': 'Hour 4: Deportment Subscale', 'categories': [{'measurements': [{'value': '5.4', 'spread': '5.22', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '3.29', 'groupId': 'OG001'}]}]}, {'title': 'Hour 8: Attention Subscale', 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.92', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.82', 'groupId': 'OG001'}]}]}, {'title': 'Hour 8: Deportment Subscale', 'categories': [{'measurements': [{'value': '4.3', 'spread': '4.73', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '4.33', 'groupId': 'OG001'}]}]}, {'title': 'Hour 10: Attention Subscale', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '3.49', 'groupId': 'OG001'}]}]}, {'title': 'Hour 10: Deportment Subscale', 'categories': [{'measurements': [{'value': '3.9', 'spread': '4.86', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '3.18', 'groupId': 'OG001'}]}]}, {'title': 'Hour 12: Attention Subscale', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.91', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '3.26', 'groupId': 'OG001'}]}]}, {'title': 'Hour 12: Deportment Subscale', 'categories': [{'measurements': [{'value': '4.2', 'spread': '4.46', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '5.48', 'groupId': 'OG001'}]}]}, {'title': 'Hour 13: Attention Subscale', 'categories': [{'measurements': [{'value': '3.8', 'spread': '3.15', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '3.35', 'groupId': 'OG001'}]}]}, {'title': 'Hour 13: Deportment Subscale', 'categories': [{'measurements': [{'value': '3.7', 'spread': '4.30', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '5.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '-0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'groupDescription': 'Hour 0.75 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '-1.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'groupDescription': 'Hour 2 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '-1.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'groupDescription': 'Hour 4 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '-0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'groupDescription': 'Hour 8 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'groupDescription': 'Hour 10 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.490', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'groupDescription': 'Hour 12 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.164', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'groupDescription': 'Hour 13 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '-0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.94', 'groupDescription': 'Hour 0.75 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '-2.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.94', 'groupDescription': 'Hour 2 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '-2.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.94', 'groupDescription': 'Hour 4 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.94', 'groupDescription': 'Hour 8 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.118', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.94', 'groupDescription': 'Hour 10 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.342', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '1.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.94', 'groupDescription': 'Hour 12 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.962', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '1.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.94', 'groupDescription': 'Hour 13 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.75, 2, 4, 8, 10, 12, 13 hours post-dose', 'description': "SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. The SKAMP subscales were obtained by summing the individual items as follows: Attention (items 1-4) and Deportment (items 5-8), where each item was rated on a 7-point scale (0=normal to 6=maximal impairment). SKAMP attention subscale was reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment. SKAMP deportment subscale was reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.'}, {'type': 'SECONDARY', 'title': 'Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (OL Phase; DB Phase)', 'description': 'Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \\[mg\\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}, {'id': 'OG001', 'title': 'NWP09 (OL Phase; DB Phase)', 'description': 'NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}], 'classes': [{'title': 'Hour 0.75: Problems attempted', 'categories': [{'measurements': [{'value': '105.4', 'spread': '51.08', 'groupId': 'OG000'}, {'value': '128.8', 'spread': '53.32', 'groupId': 'OG001'}]}]}, {'title': 'Hour 0.75: Problems corrected', 'categories': [{'measurements': [{'value': '102.8', 'spread': '51.62', 'groupId': 'OG000'}, {'value': '123.9', 'spread': '55.11', 'groupId': 'OG001'}]}]}, {'title': 'Hour 2: Problems attempted', 'categories': [{'measurements': [{'value': '106.6', 'spread': '55.22', 'groupId': 'OG000'}, {'value': '140.9', 'spread': '57.85', 'groupId': 'OG001'}]}]}, {'title': 'Hour 2: Problems corrected', 'categories': [{'measurements': [{'value': '103.7', 'spread': '55.75', 'groupId': 'OG000'}, {'value': '136.6', 'spread': '60.34', 'groupId': 'OG001'}]}]}, {'title': 'Hour 4: Problems attempted', 'categories': [{'measurements': [{'value': '107.2', 'spread': '55.89', 'groupId': 'OG000'}, {'value': '140.0', 'spread': '62.88', 'groupId': 'OG001'}]}]}, {'title': 'Hour 4: Problems corrected', 'categories': [{'measurements': [{'value': '104.2', 'spread': '56.72', 'groupId': 'OG000'}, {'value': '135.6', 'spread': '64.53', 'groupId': 'OG001'}]}]}, {'title': 'Hour 8: Problems attempted', 'categories': [{'measurements': [{'value': '101.7', 'spread': '53.32', 'groupId': 'OG000'}, {'value': '129.1', 'spread': '62.64', 'groupId': 'OG001'}]}]}, {'title': 'Hour 8: Problems corrected', 'categories': [{'measurements': [{'value': '98.5', 'spread': '53.71', 'groupId': 'OG000'}, {'value': '124.0', 'spread': '63.92', 'groupId': 'OG001'}]}]}, {'title': 'Hour 10: Problems attempted', 'categories': [{'measurements': [{'value': '103.2', 'spread': '53.54', 'groupId': 'OG000'}, {'value': '113.9', 'spread': '62.33', 'groupId': 'OG001'}]}]}, {'title': 'Hour 10: Problems corrected', 'categories': [{'measurements': [{'value': '100.8', 'spread': '53.99', 'groupId': 'OG000'}, {'value': '107.9', 'spread': '63.08', 'groupId': 'OG001'}]}]}, {'title': 'Hour 12: Problems attempted', 'categories': [{'measurements': [{'value': '97.9', 'spread': '48.86', 'groupId': 'OG000'}, {'value': '111.1', 'spread': '55.70', 'groupId': 'OG001'}]}]}, {'title': 'Hour 12: Problems corrected', 'categories': [{'measurements': [{'value': '95.1', 'spread': '49.25', 'groupId': 'OG000'}, {'value': '103.3', 'spread': '57.76', 'groupId': 'OG001'}]}]}, {'title': 'Hour 13: Problems attempted', 'categories': [{'measurements': [{'value': '98.6', 'spread': '46.01', 'groupId': 'OG000'}, {'value': '115.4', 'spread': '57.30', 'groupId': 'OG001'}]}]}, {'title': 'Hour 13: Problems corrected', 'categories': [{'measurements': [{'value': '95.0', 'spread': '45.76', 'groupId': 'OG000'}, {'value': '101.8', 'spread': '58.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.3', 'ciLowerLimit': '3.4', 'ciUpperLimit': '47.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.12', 'groupDescription': 'Hour 0.75 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.1', 'ciLowerLimit': '14.2', 'ciUpperLimit': '57.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.12', 'groupDescription': 'Hour 2 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.7', 'ciLowerLimit': '12.8', 'ciUpperLimit': '56.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.12', 'groupDescription': 'Hour 4 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.3', 'ciLowerLimit': '7.4', 'ciUpperLimit': '51.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.12', 'groupDescription': 'Hour 8 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.261', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.5', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '34.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.12', 'groupDescription': 'Hour 10 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.175', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.1', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '37.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.12', 'groupDescription': 'Hour 12 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.094', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.7', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '40.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.12', 'groupDescription': 'Hour 13 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.6', 'ciLowerLimit': '0.1', 'ciUpperLimit': '45.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.44', 'groupDescription': 'Hour 0.75 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.4', 'ciLowerLimit': '11.9', 'ciUpperLimit': '56.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.44', 'groupDescription': 'Hour 2 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.9', 'ciLowerLimit': '10.5', 'ciUpperLimit': '55.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.44', 'groupDescription': 'Hour 4 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.0', 'ciLowerLimit': '4.5', 'ciUpperLimit': '49.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.44', 'groupDescription': 'Hour 8 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.451', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.6', 'ciLowerLimit': '-13.9', 'ciUpperLimit': '31.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.44', 'groupDescription': 'Hour 10 (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.394', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.8', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '32.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.44', 'groupDescription': 'Hour 12 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.466', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.3', 'ciLowerLimit': '-14.1', 'ciUpperLimit': '30.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.44', 'groupDescription': 'Hour 13 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.75, 2, 4, 8, 10, 12 and 13 post-dose', 'description': "The PERMP score measured the manifestations of attention deficit hyperactivity disorder. The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10- minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure participant's performance. The total score range from 0-160 with higher scores indicating better performance.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinical Global Impression of Severity (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Population', 'description': 'All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.29', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Day 22', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': 'Day 36', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Day 43', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, 15, 22, 29, 36, 43', 'description': "CGI-S scale was used to measure features associated with ADHD. The assessment was performed by the investigator of the study research team. The CGI-S classified the participant's current disease status as: 1 = normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill participants. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinical Global Impression-Improvement (CGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Population', 'description': 'All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}], 'classes': [{'title': 'Day 8', 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.07', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Day 22', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.69', 'groupId': 'OG000'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.56', 'groupId': 'OG000'}]}]}, {'title': 'Day 36', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.49', 'groupId': 'OG000'}]}]}, {'title': 'Day 43', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, 15, 22, 29, 36, 43', 'description': "The CGI-I measured the participant's disease improvement relative to baseline as followed: 1= very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6= much worse, and 7=very much worse. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Conners Parent Rating Scale (CPRS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Population', 'description': 'All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}], 'classes': [{'title': 'Oppositional : Baseline', 'categories': [{'measurements': [{'value': '67.3', 'spread': '15.08', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive Problems/ Inattention: Baseline', 'categories': [{'measurements': [{'value': '71.1', 'spread': '13.30', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactivity: Baseline', 'categories': [{'measurements': [{'value': '79.3', 'spread': '16.18', 'groupId': 'OG000'}]}]}, {'title': 'Anxious-shy: Baseline', 'categories': [{'measurements': [{'value': '57.3', 'spread': '15.06', 'groupId': 'OG000'}]}]}, {'title': 'Perfectionism: Baseline', 'categories': [{'measurements': [{'value': '54.9', 'spread': '12.75', 'groupId': 'OG000'}]}]}, {'title': 'Social problems: Baseline', 'categories': [{'measurements': [{'value': '57.1', 'spread': '14.31', 'groupId': 'OG000'}]}]}, {'title': 'Psychosomatic: Baseline', 'categories': [{'measurements': [{'value': '57.1', 'spread': '17.63', 'groupId': 'OG000'}]}]}, {'title': 'ADHD index: Baseline', 'categories': [{'measurements': [{'value': '73.8', 'spread': '11.00', 'groupId': 'OG000'}]}]}, {'title': 'Restless-Impulse: Baseline', 'categories': [{'measurements': [{'value': '74.6', 'spread': '12.48', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Liability: Baseline', 'categories': [{'measurements': [{'value': '64.8', 'spread': '15.82', 'groupId': 'OG000'}]}]}, {'title': "Conner's Global index: Baseline", 'categories': [{'measurements': [{'value': '73.6', 'spread': '13.25', 'groupId': 'OG000'}]}]}, {'title': 'Inattentive: Baseline', 'categories': [{'measurements': [{'value': '73.8', 'spread': '12.57', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactive-Impulsive: Baseline', 'categories': [{'measurements': [{'value': '78.0', 'spread': '14.43', 'groupId': 'OG000'}]}]}, {'title': 'DSM-IV: Baseline', 'categories': [{'measurements': [{'value': '77.8', 'spread': '12.04', 'groupId': 'OG000'}]}]}, {'title': 'Oppositional: Day 8', 'categories': [{'measurements': [{'value': '64.0', 'spread': '15.89', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive Problems/ Inattention: Day 8', 'categories': [{'measurements': [{'value': '66.5', 'spread': '13.33', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactivity: Day 8', 'categories': [{'measurements': [{'value': '73.5', 'spread': '17.81', 'groupId': 'OG000'}]}]}, {'title': 'Anxious-shy: Day 8', 'categories': [{'measurements': [{'value': '54.9', 'spread': '13.99', 'groupId': 'OG000'}]}]}, {'title': 'Perfectionism: Day 8', 'categories': [{'measurements': [{'value': '52.7', 'spread': '11.80', 'groupId': 'OG000'}]}]}, {'title': 'Social problems: Day 8', 'categories': [{'measurements': [{'value': '55.5', 'spread': '13.06', 'groupId': 'OG000'}]}]}, {'title': 'Psychosomatic: Day 8', 'categories': [{'measurements': [{'value': '55.2', 'spread': '17.22', 'groupId': 'OG000'}]}]}, {'title': 'ADHD index: Day 8', 'categories': [{'measurements': [{'value': '68.8', 'spread': '13.30', 'groupId': 'OG000'}]}]}, {'title': 'Restless-Impulse: Day 8', 'categories': [{'measurements': [{'value': '69.7', 'spread': '14.51', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Liability: Day 8', 'categories': [{'measurements': [{'value': '62.1', 'spread': '15.25', 'groupId': 'OG000'}]}]}, {'title': "Conner's Global index: Day 8", 'categories': [{'measurements': [{'value': '68.9', 'spread': '15.06', 'groupId': 'OG000'}]}]}, {'title': 'Inattentive: Day 8', 'categories': [{'measurements': [{'value': '68.3', 'spread': '13.46', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactive-Impulsive: Day 8', 'categories': [{'measurements': [{'value': '73.1', 'spread': '16.24', 'groupId': 'OG000'}]}]}, {'title': 'DSM-IV: Day 8', 'categories': [{'measurements': [{'value': '72.1', 'spread': '14.62', 'groupId': 'OG000'}]}]}, {'title': 'Oppositional: Day 15', 'categories': [{'measurements': [{'value': '59.5', 'spread': '14.75', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive Problems/ Inattention: Day 15', 'categories': [{'measurements': [{'value': '61.8', 'spread': '12.88', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactivity: Day 15', 'categories': [{'measurements': [{'value': '68.0', 'spread': '17.58', 'groupId': 'OG000'}]}]}, {'title': 'Anxious-shy: Day 15', 'categories': [{'measurements': [{'value': '52.5', 'spread': '13.55', 'groupId': 'OG000'}]}]}, {'title': 'Perfectionism: Day 15', 'categories': [{'measurements': [{'value': '51.1', 'spread': '11.51', 'groupId': 'OG000'}]}]}, {'title': 'Social problems: Day 15', 'categories': [{'measurements': [{'value': '54.0', 'spread': '12.71', 'groupId': 'OG000'}]}]}, {'title': 'Psychosomatic: Day 15', 'categories': [{'measurements': [{'value': '53.2', 'spread': '15.93', 'groupId': 'OG000'}]}]}, {'title': 'ADHD index: Day 15', 'categories': [{'measurements': [{'value': '63.3', 'spread': '12.70', 'groupId': 'OG000'}]}]}, {'title': 'Restless-Impulse: Day 15', 'categories': [{'measurements': [{'value': '65.2', 'spread': '13.96', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Liability: Day 15', 'categories': [{'measurements': [{'value': '57.0', 'spread': '13.84', 'groupId': 'OG000'}]}]}, {'title': "Conner's Global index: Day 15", 'categories': [{'measurements': [{'value': '63.6', 'spread': '14.08', 'groupId': 'OG000'}]}]}, {'title': 'Inattentive: Day 15', 'categories': [{'measurements': [{'value': '63.0', 'spread': '13.39', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactive-Impulsive: Day 15', 'categories': [{'measurements': [{'value': '67.4', 'spread': '15.86', 'groupId': 'OG000'}]}]}, {'title': 'DSM-IV: Day 15', 'categories': [{'measurements': [{'value': '66.2', 'spread': '14.33', 'groupId': 'OG000'}]}]}, {'title': 'Oppositional: Day 22', 'categories': [{'measurements': [{'value': '55.5', 'spread': '13.27', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive Problems/ Inattention: Day 22', 'categories': [{'measurements': [{'value': '59.1', 'spread': '12.30', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactivity: Day 22', 'categories': [{'measurements': [{'value': '62.8', 'spread': '14.73', 'groupId': 'OG000'}]}]}, {'title': 'Anxious-shy: Day 22', 'categories': [{'measurements': [{'value': '50.5', 'spread': '12.66', 'groupId': 'OG000'}]}]}, {'title': 'Perfectionism: Day 22', 'categories': [{'measurements': [{'value': '49.3', 'spread': '10.08', 'groupId': 'OG000'}]}]}, {'title': 'Social problems: Day 22', 'categories': [{'measurements': [{'value': '52.6', 'spread': '12.65', 'groupId': 'OG000'}]}]}, {'title': 'Psychosomatic: Day 22', 'categories': [{'measurements': [{'value': '50.6', 'spread': '14.54', 'groupId': 'OG000'}]}]}, {'title': 'ADHD index: Day 22', 'categories': [{'measurements': [{'value': '59.7', 'spread': '12.18', 'groupId': 'OG000'}]}]}, {'title': 'Restless-Impulse: Day 22', 'categories': [{'measurements': [{'value': '59.6', 'spread': '12.86', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Liability: Day 22', 'categories': [{'measurements': [{'value': '53.3', 'spread': '12.60', 'groupId': 'OG000'}]}]}, {'title': "Conner's Global index: Day 22", 'categories': [{'measurements': [{'value': '58.4', 'spread': '13.17', 'groupId': 'OG000'}]}]}, {'title': 'Inattentive: Day 22', 'categories': [{'measurements': [{'value': '59.5', 'spread': '12.44', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactive-Impulsive: Day 22', 'categories': [{'measurements': [{'value': '63.5', 'spread': '14.48', 'groupId': 'OG000'}]}]}, {'title': 'DSM-IV: Day 22', 'categories': [{'measurements': [{'value': '62.3', 'spread': '13.30', 'groupId': 'OG000'}]}]}, {'title': 'Oppositional: Day 29', 'categories': [{'measurements': [{'value': '52.8', 'spread': '11.28', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive Problems/ Inattention: Day 29', 'categories': [{'measurements': [{'value': '55.7', 'spread': '10.97', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactivity: Day 29', 'categories': [{'measurements': [{'value': '58.2', 'spread': '12.87', 'groupId': 'OG000'}]}]}, {'title': 'Anxious-shy: Day 29', 'categories': [{'measurements': [{'value': '49.8', 'spread': '12.08', 'groupId': 'OG000'}]}]}, {'title': 'Perfectionism: Day 29', 'categories': [{'measurements': [{'value': '48.3', 'spread': '9.63', 'groupId': 'OG000'}]}]}, {'title': 'Social problems: Day 29', 'categories': [{'measurements': [{'value': '51.2', 'spread': '10.40', 'groupId': 'OG000'}]}]}, {'title': 'Psychosomatic: Day 29', 'categories': [{'measurements': [{'value': '49.7', 'spread': '12.13', 'groupId': 'OG000'}]}]}, {'title': 'ADHD index: Day 29', 'categories': [{'measurements': [{'value': '55.7', 'spread': '9.88', 'groupId': 'OG000'}]}]}, {'title': 'Restless-Impulse: Day 29', 'categories': [{'measurements': [{'value': '55.9', 'spread': '10.77', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Liability: Day 29', 'categories': [{'measurements': [{'value': '51.0', 'spread': '10.29', 'groupId': 'OG000'}]}]}, {'title': "Conner's Global index: Day 29", 'categories': [{'measurements': [{'value': '54.8', 'spread': '10.88', 'groupId': 'OG000'}]}]}, {'title': 'Inattentive: Day 29', 'categories': [{'measurements': [{'value': '55.6', 'spread': '11.19', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactive-Impulsive: Day 29', 'categories': [{'measurements': [{'value': '57.8', 'spread': '12.08', 'groupId': 'OG000'}]}]}, {'title': 'DSM-IV: Day 29', 'categories': [{'measurements': [{'value': '57.1', 'spread': '11.10', 'groupId': 'OG000'}]}]}, {'title': 'Oppositional: Day 36', 'categories': [{'measurements': [{'value': '50.5', 'spread': '10.42', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive Problems/ Inattention: Day 36', 'categories': [{'measurements': [{'value': '54.7', 'spread': '11.44', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactivity: Day 36', 'categories': [{'measurements': [{'value': '56.0', 'spread': '12.36', 'groupId': 'OG000'}]}]}, {'title': 'Anxious-shy: Day 36', 'categories': [{'measurements': [{'value': '49.0', 'spread': '10.90', 'groupId': 'OG000'}]}]}, {'title': 'Perfectionism: Day 36', 'categories': [{'measurements': [{'value': '46.6', 'spread': '8.08', 'groupId': 'OG000'}]}]}, {'title': 'Social problems: Day 36', 'categories': [{'measurements': [{'value': '50.1', 'spread': '10.10', 'groupId': 'OG000'}]}]}, {'title': 'Psychosomatic: Day 36', 'categories': [{'measurements': [{'value': '47.9', 'spread': '10.37', 'groupId': 'OG000'}]}]}, {'title': 'ADHD index: Day 36', 'categories': [{'measurements': [{'value': '53.8', 'spread': '10.15', 'groupId': 'OG000'}]}]}, {'title': 'Restless-Impulse: Day 36', 'categories': [{'measurements': [{'value': '54.3', 'spread': '10.79', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Liability: Day 36', 'categories': [{'measurements': [{'value': '49.8', 'spread': '9.76', 'groupId': 'OG000'}]}]}, {'title': "Conner's Global index: Day 36", 'categories': [{'measurements': [{'value': '53.3', 'spread': '10.90', 'groupId': 'OG000'}]}]}, {'title': 'Inattentive: Day 36', 'categories': [{'measurements': [{'value': '54.7', 'spread': '11.49', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactive-Impulsive: Day 36', 'categories': [{'measurements': [{'value': '55.2', 'spread': '11.15', 'groupId': 'OG000'}]}]}, {'title': 'DSM-IV: Day 36', 'categories': [{'measurements': [{'value': '55.4', 'spread': '10.96', 'groupId': 'OG000'}]}]}, {'title': 'Oppositional: Day 43', 'categories': [{'measurements': [{'value': '49.8', 'spread': '10.81', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive Problems/ Inattention: Day 43', 'categories': [{'measurements': [{'value': '54.0', 'spread': '11.48', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactivity: Day 43', 'categories': [{'measurements': [{'value': '54.4', 'spread': '10.63', 'groupId': 'OG000'}]}]}, {'title': 'Anxious-shy: Day 43', 'categories': [{'measurements': [{'value': '47.9', 'spread': '10.80', 'groupId': 'OG000'}]}]}, {'title': 'Perfectionism: Day 43', 'categories': [{'measurements': [{'value': '45.9', 'spread': '7.60', 'groupId': 'OG000'}]}]}, {'title': 'Social problems: Day 43', 'categories': [{'measurements': [{'value': '50.5', 'spread': '10.77', 'groupId': 'OG000'}]}]}, {'title': 'Psychosomatic: Day 43', 'categories': [{'measurements': [{'value': '47.2', 'spread': '9.87', 'groupId': 'OG000'}]}]}, {'title': 'ADHD index: Day 43', 'categories': [{'measurements': [{'value': '52.9', 'spread': '9.84', 'groupId': 'OG000'}]}]}, {'title': 'Restless-Impulse: Day 43', 'categories': [{'measurements': [{'value': '53.2', 'spread': '10.37', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Liability: Day 43', 'categories': [{'measurements': [{'value': '48.9', 'spread': '9.21', 'groupId': 'OG000'}]}]}, {'title': "Conner's Global index: Day 43", 'categories': [{'measurements': [{'value': '52.1', 'spread': '10.16', 'groupId': 'OG000'}]}]}, {'title': 'Inattentive: Day 43', 'categories': [{'measurements': [{'value': '53.8', 'spread': '11.14', 'groupId': 'OG000'}]}]}, {'title': 'Hyperactive-Impulsive: Day 43', 'categories': [{'measurements': [{'value': '54.3', 'spread': '10.30', 'groupId': 'OG000'}]}]}, {'title': 'DSM-IV: Day 43', 'categories': [{'measurements': [{'value': '54.3', 'spread': '10.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, 15, 22, 29, 36, 43', 'description': "CPRS was used to measure features associated with ADHD and was used to compare scores during the dose optimization period i.e. 1-6 weeks. The assessment was performed by parent or guardian. CPRS consisted of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true). Raw scores were converted to t-scores and t-scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. The participant received normalized t-scores on the following scales: oppositional, cognitive problems/inattention, hyperactivity, anxious-shy, perfectionism, social problems, psychosomatic, ADHD index, restless-impulse, emotional liability, conner's global index, inattentive, hyperactive-impulsive and diagnostic and statistical manual of mental disorders IV (DSM-IV). This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo (OL Phase; DB Phase)', 'description': 'Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \\[mg\\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}, {'id': 'FG001', 'title': 'NWP09 (OL Phase; DB Phase)', 'description': 'NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Total 90 participants were enrolled in this study, out of which 86 participants were randomized.', 'preAssignmentDetails': 'The study consisted of an open-label (OL) dose-optimization phase (1 to 6 weeks), and a placebo-controlled, double blind (DB) for 1 week with no dose adjustments.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (OL Phase; DB Phase)', 'description': 'Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram \\[mg\\] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}, {'id': 'BG001', 'title': 'NWP09 (OL Phase; DB Phase)', 'description': 'NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '1.62', 'groupId': 'BG000'}, {'value': '9.9', 'spread': '1.71', 'groupId': 'BG001'}, {'value': '9.6', 'spread': '1.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent to treat (ITT) population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'dispFirstSubmitDate': '2013-11-05', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2012-04-27', 'dispFirstSubmitQcDate': '2013-11-05', 'resultsFirstSubmitDate': '2016-01-04', 'studyFirstSubmitQcDate': '2012-07-26', 'dispFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-04', 'studyFirstPostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical Global Impression of Severity (CGI-S)', 'timeFrame': 'Baseline, Day 8, 15, 22, 29, 36, 43', 'description': "CGI-S scale was used to measure features associated with ADHD. The assessment was performed by the investigator of the study research team. The CGI-S classified the participant's current disease status as: 1 = normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill participants. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups."}, {'measure': 'Clinical Global Impression-Improvement (CGI-I)', 'timeFrame': 'Day 8, 15, 22, 29, 36, 43', 'description': "The CGI-I measured the participant's disease improvement relative to baseline as followed: 1= very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6= much worse, and 7=very much worse. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups."}, {'measure': 'Conners Parent Rating Scale (CPRS) Scores', 'timeFrame': 'Baseline, Day 8, 15, 22, 29, 36, 43', 'description': "CPRS was used to measure features associated with ADHD and was used to compare scores during the dose optimization period i.e. 1-6 weeks. The assessment was performed by parent or guardian. CPRS consisted of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true). Raw scores were converted to t-scores and t-scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. The participant received normalized t-scores on the following scales: oppositional, cognitive problems/inattention, hyperactivity, anxious-shy, perfectionism, social problems, psychosomatic, ADHD index, restless-impulse, emotional liability, conner's global index, inattentive, hyperactive-impulsive and diagnostic and statistical manual of mental disorders IV (DSM-IV). This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups."}], 'primaryOutcomes': [{'measure': 'Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points', 'timeFrame': '0.75 up to 13 hours post-dose', 'description': "The SKAMP scale measured the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment. Average of all post dose SKAMP-combined scores measured at 0.75, 2, 4, 8, 10, 12 and 13 hours post-dose was calculated."}], 'secondaryOutcomes': [{'measure': 'Onset and Duration of Clinical Effect', 'timeFrame': '0.75, 2, 4, 8, 10, 12, 13 hours post-dose', 'description': "Onset and duration of clinical effect was determined using SKAMP combined rating scale at each post-dose time point. Onset of effect was defined as first assessment time showing statistical significance (i.e. p was less than or equal to \\[=\\<\\] 0.05) between NWP09 and placebo and duration of effect was defined as the as last consecutive time-point at which difference was statistically significant between NWP09 and placebo. SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score was comprised of 13 items \\[subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)\\]. SKAMP combined score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment."}, {'measure': 'Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose', 'timeFrame': '0.75, 2, 4, 8, 10, 12, 13 hours post-dose', 'description': "SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. The SKAMP subscales were obtained by summing the individual items as follows: Attention (items 1-4) and Deportment (items 5-8), where each item was rated on a 7-point scale (0=normal to 6=maximal impairment). SKAMP attention subscale was reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment. SKAMP deportment subscale was reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment."}, {'measure': 'Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose', 'timeFrame': '0.75, 2, 4, 8, 10, 12 and 13 post-dose', 'description': "The PERMP score measured the manifestations of attention deficit hyperactivity disorder. The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10- minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure participant's performance. The total score range from 0-160 with higher scores indicating better performance."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADHD', 'methylphenidate extended-release'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '28557548', 'type': 'DERIVED', 'citation': 'Wigal SB, Childress A, Berry SA, Belden H, Walters F, Chappell P, Sherman N, Orazem J, Palumbo D. Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2017 Oct;27(8):690-699. doi: 10.1089/cap.2016.0177. Epub 2017 May 30.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=NWP09-ADHD-300&StudyName=NWP09%20in%20Children%20with%20Attention%20Deficit%20Hyperactivity%20Disorder%20%28ADHD%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition\n\nExclusion Criteria:\n\n* Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD'}, 'identificationModule': {'nctId': 'NCT01654250', 'briefTitle': 'NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicenter, Dose-optimized, Double-blind, Randomized, Placebo-controlled Study To Evaluate The Efficacy Of Nwp09 In Pediatric Patients With Attention Deficit Hyperactivity Disorder (Adhd) In A Laboratory Classroom', 'orgStudyIdInfo': {'id': 'NWP09-ADHD-300'}, 'secondaryIdInfos': [{'id': 'B7491005', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'NWP09', 'interventionNames': ['Drug: NWP09']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NWP09', 'type': 'DRUG', 'description': 'Methylphenidate, variable dose, daily dosing, 1 week duration', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Study Centers, LLC', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92646', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Laboratory School', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92612', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Child Development Center', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine - Hewitt Hall', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '34201', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clinical Research Center, LLC', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '34202', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Woodland Community Church (Laboratory School)', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Center for Psychiatry and Behavioral Medicine, Inc.', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '77007', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Bayou City Research, Ltd.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79423', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Westex Clinical Investigations', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}