Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT01328756
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2011-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069478', 'term': 'Lisdexamfetamine Dimesylate'}], 'ancestors': [{'id': 'D003913', 'term': 'Dextroamphetamine'}, {'id': 'D000661', 'term': 'Amphetamine'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Since this study is an open-label trial, results should be interpreted with caution.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 3 days after the last dose of study treatment (up to 2 years)', 'description': "AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.", 'eventGroups': [{'id': 'EG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (Vyvanse, SPD489) 30 to 70 mg capsule once daily orally.', 'otherNumAtRisk': 314, 'otherNumAffected': 250, 'seriousNumAtRisk': 314, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 37, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 34, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 41, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 33, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 39, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 40, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 129, 'numAffected': 73}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 68, 'numAffected': 63}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 214, 'numAffected': 170}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 139, 'numAffected': 68}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 46, 'numAffected': 38}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 75, 'numAffected': 60}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Tic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 25, 'numAffected': 18}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'seriousEvents': [{'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Disbacteriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Infectious peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Mumps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Retroperitoneal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Agitation postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Oppositional defiant disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Testicular torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '282', 'groupId': 'OG000'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 3 days after the last dose of study treatment (up to 2 years)', 'description': "An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who took at least 1 dose of Lisdexamfetamine dimesylate during this study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '11.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with participants evaluable for this outcome'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '9.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with participants evaluable for this outcome'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '10.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with participants evaluable for this outcome'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '5.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'unitOfMeasure': 'kilogram(s)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with participants evaluable for this outcome'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Height at Last On-treatment Assessment (LOTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '4.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'unitOfMeasure': 'centimeter(s)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with participants evaluable for this outcome'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'description': 'BMI was calculated as (weight \\[kilogram\\] per height \\[square meter\\]).', 'unitOfMeasure': 'kilogram per square meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with participants evaluable for this outcome'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '13.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with participants evaluable for this outcome'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.3', 'spread': '23.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with participants evaluable for this outcome'}, {'type': 'PRIMARY', 'title': "Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '15.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with participants evaluable for this outcome'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.3', 'spread': '9.64', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'description': "The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with participants evaluable for this outcome'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.8', 'spread': '11.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from baseline to LOTA value was assessed for differences from zero using a 2-sided, 1 sample t-test at a 0.05 significance level.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'description': 'ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all participants who took at least 1 dose of SPD489 and had at least 1 on-treatment post baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Minimally improved', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Minimally worse', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'LOTA (Week 104)', 'description': "The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-I was a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), evaluated by the Investigator.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'classes': [{'title': 'Normal, not all ill', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Borderline mentally ill', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'Mildly ill', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Moderately ill', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Markedly ill', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Severely ill', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Among the most extremely ill participants', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'LOTA (Week 104)', 'description': "The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 milligram (mg) capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period. At optimization period, participants started SPD489 30 mg and dose was titrated until acceptable response (30% reduction from baseline in ADHD Rating Scale-IV total score, clinical global impression-improvement \\[CGI-I\\]score of 1 or 2 with tolerable side effects) was achieved. Maximum dose was 70mg. Dose adjustments were done in dose maintenance period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '314'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}]}]}], 'recruitmentDetails': 'This study enrolled participants from 3 antecedent studies (SPD489-317 \\[NCT01106430\\], SPD489-325 \\[NCT00763971\\], and SPD489-326 \\[NCT00784654\\]), or directly enrolled.', 'preAssignmentDetails': 'If participants from previous SDP489 studies had a gap of more than 7 days before participation in this study, they were required to have baseline Attention-Deficit/Hyperactivity Disorder (ADHD) total score of at least 28, to be enrolled. Of 348 participants screened, 314 participants were enrolled and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lisdexamfetamine Dimesylate', 'description': 'Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '2.88', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '250', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical Global Impressions - Severity of Illness (CGI-S) Rating', 'classes': [{'title': 'Normal, not all ill', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Borderline mentally ill', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Mildly ill', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Moderately ill', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}, {'title': 'Markedly ill', 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}]}]}, {'title': 'Severely ill', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}, {'title': 'Among the most extremely ill participants', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participant's severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator.", 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '46.13', 'spread': '16.434', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram(s)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '152.29', 'spread': '16.633', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '19.22', 'spread': '3.389', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'BMI was calculated as (weight \\[kilogram\\] per height \\[square meter\\]) at screening.', 'unitOfMeasure': 'kilogram per square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV): Total Score', 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '7.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ADHD-RS-IV: Inattention Subscale Score', 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'spread': '3.52', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on DSM-IV-TR criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity and inattention. Inattention subscale score consisted of odd number items 1-17 with scores ranging from 0 to 27. Higher score indicated worse symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ADHD-RS-IV: Hyperactivity/Impulsivity Subscore', 'classes': [{'categories': [{'measurements': [{'value': '19', 'spread': '5.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on DSM-IV-TR criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity and inattention. Hyperactivity/impulsivity subscale score consisted of even number items 2-18 with scores ranging from 0 to 27. Higher score indicated worse symptom.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2014-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-25', 'studyFirstSubmitDate': '2011-03-29', 'resultsFirstSubmitDate': '2015-05-15', 'studyFirstSubmitQcDate': '2011-04-01', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-09', 'studyFirstPostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs', 'timeFrame': 'Baseline up to 3 days after the last dose of study treatment (up to 2 years)', 'description': "An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment."}, {'measure': 'Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA)', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)'}, {'measure': 'Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA)', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)'}, {'measure': 'Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA)', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)'}, {'measure': 'Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA)', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)'}, {'measure': 'Change From Baseline in Height at Last On-treatment Assessment (LOTA)', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)'}, {'measure': 'Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA)', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'description': 'BMI was calculated as (weight \\[kilogram\\] per height \\[square meter\\]).'}, {'measure': 'Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA)', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)'}, {'measure': 'Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA)', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)'}, {'measure': "Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA)", 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)'}, {'measure': 'Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA)', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'description': "The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA)', 'timeFrame': 'Baseline (Week 0), LOTA (Week 104)', 'description': 'ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms.'}, {'measure': 'Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)', 'timeFrame': 'LOTA (Week 104)', 'description': "The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-I was a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), evaluated by the Investigator."}, {'measure': 'Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)', 'timeFrame': 'LOTA (Week 104)', 'description': "The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator."}]}, 'conditionsModule': {'keywords': ['ADHD'], 'conditions': ['Attention Deficit Hyperactivity Disorder (ADHD)']}, 'referencesModule': {'references': [{'pmid': '29790103', 'type': 'DERIVED', 'citation': 'Banaschewski T, Johnson M, Nagy P, Otero IH, Soutullo CA, Yan B, Zuddas A, Coghill DR. Growth and Puberty in a 2-Year Open-Label Study of Lisdexamfetamine Dimesylate in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2018 May;32(5):455-467. doi: 10.1007/s40263-018-0514-8.'}, {'pmid': '29383572', 'type': 'DERIVED', 'citation': 'Coghill DR, Banaschewski T, Bliss C, Robertson B, Zuddas A. Cognitive Function of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder in a 2-Year Open-Label Study of Lisdexamfetamine Dimesylate. CNS Drugs. 2018 Jan;32(1):85-95. doi: 10.1007/s40263-017-0487-z.'}, {'pmid': '28667569', 'type': 'DERIVED', 'citation': 'Coghill DR, Banaschewski T, Nagy P, Otero IH, Soutullo C, Yan B, Caballero B, Zuddas A. Long-Term Safety and Efficacy of Lisdexamfetamine Dimesylate in Children and Adolescents with ADHD: A Phase IV, 2-Year, Open-Label Study in Europe. CNS Drugs. 2017 Jul;31(7):625-638. doi: 10.1007/s40263-017-0443-y.'}]}, 'descriptionModule': {'briefSummary': 'While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy, safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have been of short duration - up to 8 weeks.\n\nA number of long-term studies have been undertaken (up to 1 year) and these have confirmed the safety and ongoing efficacy in this patient population.\n\nIn order to run a study with investigational medication within Poland the study changed to a Phase 3 rather than a Phase 4 study in that country. Please note that the study number remains as SPD489-404.\n\nStudy SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in children and adolescents over a 2-year treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489 326):\n\n* Subject is a male or female aged 6-17 years.\n* Subject participated in SPD489-317, completed 9 weeks of treatment, and completed the 1 week post-treatment safety follow-up visit.\n\nFor subjects who have not participated in another SPD489 study:\n\n* Subject is a male or female aged 6-17 years.\n* Subject must meet DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.\n\nFor all subjects:\n\n* Subject has a Baseline ADHD-RS-IV total score greater than or equal to 28.\n* Subject, who is female of childbearing potential (FOCP), must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test, and a negative urine pregnancy test at Baseline, be non-lactating and agree to comply with any applicable contraceptive requirements of the protocol.\n* Subject and parent/LAR are willing and able to comply with all the testing and requirements defined, including oversight of morning dosing. Specifically, the parent/LAR must be available upon awakening, at approximately 7:00 AM, to dispense the dose of Investigational Product for the duration of the study.\n* Subject aged greater than or equal to 18 years has a systolic blood pressure less than or equal to 139 mmHg and a diastolic blood pressure less than or equal to 89 mmHg.\n* Subject is able to swallow a capsule.\n\nExclusion Criteria:\n\nFor subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489 326):\n\n* Subject was terminated from a previous SPD489 study (SPD489-325 or SPD489 326) for protocol non-adherence and/or subject non-compliance and/or experienced a medication-related SAE or AE resulting in termination from the previous study.\n* Subject experienced any clinically significant AEs in a prior SPD489 study (SPD489 317, SPD489-325, or SPD489-326) that, in the opinion of the Investigator, would preclude further exposure to SPD489.\n\nFor all subjects:\n\n* Subject's symptoms are well-controlled on their currently prescribed ADHD medication with acceptable tolerability.\n* Subject has a positive urine drug result at Screening.\n* Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder (such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations, such as agitated states, marked anxiety, or tension.\n* Subject has taken another Investigational Product or taken part in a clinical study with the exception of a prior SPD489 study (SPD489-317, SPD489 325, or SPD489 326) within 30 days prior to Screening.\n* Subject weighs less than 22.7 kg (50 lbs).\n* Subject is significantly overweight.\n* Subject has a conduct disorder. Oppositional defiant disorder is not exclusionary.\n* Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the subject.\n* Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator\n* Subject has glaucoma.\n* Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.\n* Subject has any clinically significant ECG abnormality.\n* Subject has any clinically significant laboratory abnormalities.\n* Subject has a documented allergy, hypersensitivity, or intolerance to any active ingredient or excipients in SPD489.\n* Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria.\n* Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, a current diagnosis of Tourette's Disorder, or a known family history of Tourette's Disorder. Subject has a history of tics that is judged by the Investigator to be exclusionary.\n* Subject has a known history of symptomatic cardiovascular or cerebrovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.\n* Subject has a known family history of sudden cardiac death or ventricular arrhythmia.\n* Subject has a medical condition, other than ADHD, that requires treatment with medications that have central nervous system effects and/or affect performance. Stable use of anticholinergic or theophylline bronchodilators is not exclusionary."}, 'identificationModule': {'nctId': 'NCT01328756', 'briefTitle': 'Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)', 'nctIdAliases': ['NCT01413165'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 4, Open-Label, Multicentre, Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': 'SPD489-404'}, 'secondaryIdInfos': [{'id': '2010-020951-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lisdexamfetamine Dimesylate', 'interventionNames': ['Drug: Lisdexamfetamine dimesylate']}], 'interventions': [{'name': 'Lisdexamfetamine dimesylate', 'type': 'DRUG', 'otherNames': ['Vyvanse, SPD489, LDX'], 'description': 'Optimized dose of either 30, 50 or 70 mg capsule administered once daily for 2 years', 'armGroupLabels': ['Lisdexamfetamine Dimesylate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2660', 'city': 'Hoboken', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Antwerpen, Commandant Weynsstraat 165 Campus Hoge Beuken', 'geoPoint': {'lat': 51.17611, 'lon': 4.34844}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Afdeling Psychiatrie', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '79104', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Albert-Ludwigs-Universität Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '68159', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Zentralinstitut für Seelische Gesundheit Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '96047', 'city': 'Bamberg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Schwerpunktpraxis für Entwicklung und Lernen', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'zip': '97070', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Medizinisches Studienzentrum Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '58093', 'city': 'Hagen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Praxis Dr.Christian Wolff', 'geoPoint': {'lat': 51.36081, 'lon': 7.47168}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '22415', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Praxis Dr. med. Friedrich Kaiser und Dr. med. 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