Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-02-28 @ 2:29 PM
Study NCT ID:
NCT04485104
Status:
TERMINATED
Last Update Posted:
2025-10-31
First Post:
2020-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D013036', 'term': 'Spasms, Infantile'}, {'id': 'D014402', 'term': 'Tuberous Sclerosis'}, {'id': 'C565346', 'term': 'Tuberous Sclerosis 1'}, {'id': 'C566021', 'term': 'Tuberous Sclerosis 2'}, {'id': 'D065768', 'term': 'Lennox Gastaut Syndrome'}, {'id': 'D004831', 'term': 'Epilepsies, Myoclonic'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004829', 'term': 'Epilepsy, Generalized'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}, {'id': 'D006222', 'term': 'Hamartoma'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D065703', 'term': 'Malformations of Cortical Development, Group I'}, {'id': 'D054220', 'term': 'Malformations of Cortical Development'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002185', 'term': 'Cannabidiol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@JazzPharma.com', 'phone': '+1 215-832-3750', 'title': 'Director Clinical Trial Disclosure & Transparency', 'organization': 'Jazz Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Three participants were enrolled. There was not enough information to answer the research questions. The limited data collected were not enough to provide meaningful conclusions regarding the efficacy, safety, and PK of CBD-OS in this clinical trial.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline up to 62 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Change in seizure presentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to the post-treatment safety follow-up visit, up to 62 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '9.90', 'groupId': 'OG000'}, {'value': '11.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '13.5', 'spread': '19.09', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood pressure was assessed in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.0', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '11.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pulse rate was assessed in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.0', 'spread': '16.97', 'groupId': 'OG000'}, {'value': '0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'breaths/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Respiratory rate was assessed in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Body Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.354', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Body temperature was assessed in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.95', 'spread': '1.344', 'groupId': 'OG000'}, {'value': '4.20', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Height was assessed in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '0.354', 'groupId': 'OG000'}, {'value': '0.60', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'kilogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Body weight was assessed in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}, {'value': '8.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Heart rate was assessed in participants with available data in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in RR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}, {'value': '-45.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'millisecond', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RR interval was assessed in participants with available data in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '12.73', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'millisecond', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PR interval was assessed in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in QRS Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '6.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'millisecond', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'QRS duration was assessed in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '8.49', 'groupId': 'OG000'}, {'value': '0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'millisecond', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'QT interval was assessed in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in QTcB and QTcF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'title': 'QTcB', 'categories': [{'measurements': [{'value': '-10.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}, {'value': '16.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'QTcF', 'categories': [{'measurements': [{'value': '-4.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}, {'value': '9.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'millisecond', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'QTcB and QTcF were assessed in participants with available data in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With a Clinically Significant Change in Laboratory Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'title': 'Alanine aminotransferase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Gamma Glutamyltransferase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinically significant change in laboratory parameters were assessed in participants with available data in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Emergence of New Types of Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'New types of seizures were assessed in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Plasma Concentrations of GWP42003-P and Its Major Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'title': 'CBD (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.3', 'spread': '46.3', 'groupId': 'OG000'}, {'value': '99.8', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'CBD (3-hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '456', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}, {'value': '427', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'CBD (6-hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '149', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': '7-OH-CBD (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.8', 'spread': '29.7', 'groupId': 'OG000'}, {'value': '123', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': '7-OH-CBD (3-hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '161', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}, {'value': '580', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': '7-OH-CBD (6-hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '292', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': '7-COOH-CBD (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2790', 'spread': '884', 'groupId': 'OG000'}, {'value': '7460', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': '7-COOH-CBD (3-hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4870', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}, {'value': '10700', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': '7-COOH-CBD (6-hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9680', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 3 hours and 6 hours post dose at End of Treatment (Week 52)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics were assessed and reported for participants when samples were collected. For both participants with Tuberous Sclerosis Complex, it was not possible to collect PK samples at 6hr post dose.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Based on Percentage Change From Baseline in Indication-Specific Total Countable Seizures as Recorded by Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'title': 'Day 1-29: > 25% (increase)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1-29: >= 0% to <=25% (increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1-29: > -25% to 0% (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1-29: <= -25% to > -50% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 1-29: <= -50% to > -75% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1-29: <= -75% (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 30-57: > 25% (increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 30-57: >= 0% to <=25% (increase)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 30-57: > -25% to 0% (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 30-57: <= -25% to > -50% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 30-57: <= -50% to > -75% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 30-57: <= -75% (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 58-85: > 25% (increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 58-85: >= 0% to <=25% (increase)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 58-85: > -25% to 0% (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 58-85: <= -25% to > -50% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 58-85: <= -50% to > -75% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 58-85: <= -75% (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 86-113: > 25% (increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 86-113: >= 0% to <=25% (increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 86-113: > -25% to 0% (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 86-113: <= -25% to > -50% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 86-113: <= -50% to > -75% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 86-113: <= -75% (reduction)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 114-141: > 25% (increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 114-141: >= 0% to <=25% (increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 114-141: > -25% to 0% (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 114-141: <= -25% to > -50% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 114-141: <= -50% to > -75% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 114-141: <= -75% (reduction)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 142-169: > 25% (increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 142-169: >= 0% to <=25% (increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 142-169: > -25% to 0% (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 142-169: <= -25% to > -50% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 142-169: <= -50% to > -75% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 142-169: <= -75% (reduction)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 170-197: > 25% (increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 170-197: >= 0% to <=25% (increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 170-197: > -25% to 0% (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 170-197: <= -25% to > -50% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 170-197: <= -50% to > -75% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 170-197: <= -75% (reduction)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Taper Period: > 25% (increase)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Taper Period: >= 0% to <=25% (increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Taper Period: > -25% to 0% (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Taper Period: <= -25% to > -50% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Taper Period: <= -50% to > -75% change (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Taper Period: <= -75% (reduction)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Taper Period, up to Week 52', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Indication-specific total countable seizures where assessed in the Safety Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Clinician Global Impression of Severity (CGI/S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'title': 'Sensory', 'categories': [{'measurements': [{'value': '3.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Motor', 'categories': [{'measurements': [{'value': '3.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Cognition', 'categories': [{'measurements': [{'value': '4.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Emotional/Behavioral', 'categories': [{'measurements': [{'value': '3.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Communication', 'categories': [{'measurements': [{'value': '4.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Social', 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Adaptive Functioning', 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 365 (EOT)', 'description': 'The CGIC/S is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores are reported.\n\nThe severity of impairment in each domain is rated by the clinician in a scale of 1 through 7 where 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Higher scores indicate poor clinical outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CGI-S was assessed and reported for the participant with Dravet Syndrome. As both participants with Tuberous Sclerosis Complex consented under a previous protocol version that did not include CGI S, this assessment was not collected for these participants.'}, {'type': 'PRIMARY', 'title': 'Clinician Global Impression of Change (CGI/C) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'title': 'Sensory', 'categories': [{'measurements': [{'value': '3.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Motor', 'categories': [{'measurements': [{'value': '3.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Cognition', 'categories': [{'measurements': [{'value': '3.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Emotional/Behavioral', 'categories': [{'measurements': [{'value': '3.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Communication', 'categories': [{'measurements': [{'value': '4.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Social', 'categories': [{'measurements': [{'value': '3.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Adaptive Functioning', 'categories': [{'measurements': [{'value': '4.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 365 (EOT)', 'description': 'The CGI/C is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores are reported.\n\nThe severity of impairment in each domain is rated by the clinician in a scale of 1 through 7 where 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Higher scores indicate poor clinical outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CGI-C was assessed and reported for the participant with Dravet Syndrome. As both participants with Tuberous Sclerosis Complex consented under a previous protocol version that did not include CGI-C, this assessment was not collected for these participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Infant and Toddler Quality of Life Questionnaire Short Form 47 (ITQOL-47) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'title': 'Bodily Pain/Discomfort Zone', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG000'}, {'value': '12.50', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Combined Behavior Scale', 'categories': [{'measurements': [{'value': '17.90', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG000'}, {'value': '0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Change in Health Score', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG000'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Family Cohesion Score', 'categories': [{'measurements': [{'value': '-55.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG000'}, {'value': '15.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Growth and Development Score', 'categories': [{'measurements': [{'value': '5.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG000'}, {'value': '-15.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'General Health Perceptions Score', 'categories': [{'measurements': [{'value': '-20.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG000'}, {'value': '-20.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Overall Health Score', 'categories': [{'measurements': [{'value': '25.0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG000'}, {'value': '0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Physical Abilities Score', 'categories': [{'measurements': [{'value': '11.10', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG000'}, {'value': '-5.60', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Parental Impact-Emotional Score', 'categories': [{'measurements': [{'value': '-25.00', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG000'}, {'value': '12.50', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Parental Impact-Time Score', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG000'}, {'value': '8.30', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Temperament and Moods Score', 'categories': [{'measurements': [{'value': '-8.30', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG000'}, {'value': '4.20', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated on 1 person.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 365 (EOT)', 'description': 'The Infant and Toddler Quality of Life Questionnaire Short Form 47 (ITQOL-47) was developed for use in infants and toddlers from 12-months-to-5 years of age and assesses levels of health and well-being. The caregiver will complete the assessment on an electronic device. For each concept, item responses are scored, summed, and transformed on a scale from 0 (worst health) to 100 (best health). Higher scores indicate better clinical outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITQOL-47 score was assessed in participants with available data in the Safety Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'title': 'Day 1-29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 30-57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 58-85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 86-113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 114-141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 142-169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 170-197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Taper Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to the taper period, up to Week 52', 'description': 'Treatment Responders are defined as participants with ≥ 50% reduction from baseline in caregiver-reported total countable seizures', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment response was assessed and reported for participants with available data. The participant with Dravet Syndrome was not assessed at the last 3 timepoints due to early withdrawal from the study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage Change From Baseline in Indication-Specific Seizure Frequency As Recorded by Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'title': 'Day 1-29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.05', 'spread': '26.23', 'groupId': 'OG000'}, {'value': '-67.80', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Day 30-57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.80', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}, {'value': '-89.50', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Day 58-85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.70', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}, {'value': '-94.70', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Day 86-113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-95.20', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}, {'value': '-80.20', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Day 114-141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-97.60', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}, {'value': '-85.80', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG001'}]}]}, {'title': 'Day 142-169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-97.80', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}]}]}, {'title': 'Day 170-197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-88.10', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}]}]}, {'title': 'Taper Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.90', 'spread': 'NA', 'comment': 'Standard deviation cannot be calculated for 1 person.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Taper Period, up to Week 52', 'unitOfMeasure': 'seizure frequency', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Seizure frequency was assessed in participants with available data in the Safety Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Seizure-Free Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12, and every 4 weeks thereafter, up to date of withdrawal or Week 24, whichever occurs first', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seizure free status is reported for the 2 participants that remained on the study for \\> 12 weeks, and data are reported up to the timepoint prior to their withdrawal from the study. One participant with Tuberous Sclerosis Complex withdrew from the study prior to week 12 so their seizure free status could not be assessed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Still Receiving GWP42003-P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'OG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12, and every 4 weeks thereafter, up to date of withdrawal or Week 24, whichever occurs first', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage of participants still receiving GWP42003-P is reported to the point at which subjects terminated their treatment and withdrew from the study. One participant with Tuberous Sclerosis Complex withdrew from the study prior to week 12. One participant with Tuberous Sclerosis Complex withdrew following the Day 170-197 timepoint. The participant with Dravet Syndrome withdrew following the Day 142-169 timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'FG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Decision by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 3 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 3 sites in the United States.', 'preAssignmentDetails': 'The study duration will be up to approximately 62 weeks, including a 4-week screening/baseline period, a 52-week dose optimisation treatment period (which includes a fixed 2-week titration period followed by flexible dose optimisation), a 10-day taper period, and a safety follow-up period (4 weeks after the end-of-taper visit).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tuberous Sclerosis Complex', 'description': 'Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'BG001', 'title': 'Dravet Syndrome', 'description': 'Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Demographic characteristics were assessed in the Safety Analysis Set.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-24', 'size': 16861116, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-18T10:28', 'hasProtocol': True}, {'date': '2025-03-04', 'size': 8459341, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-18T10:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'The study was terminated by the Sponsor due to low patient enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2020-07-21', 'resultsFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-17', 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Infant and Toddler Quality of Life Questionnaire Short Form 47 (ITQOL-47) Score', 'timeFrame': 'At Day 365 (EOT)', 'description': 'The Infant and Toddler Quality of Life Questionnaire Short Form 47 (ITQOL-47) was developed for use in infants and toddlers from 12-months-to-5 years of age and assesses levels of health and well-being. The caregiver will complete the assessment on an electronic device. For each concept, item responses are scored, summed, and transformed on a scale from 0 (worst health) to 100 (best health). Higher scores indicate better clinical outcome.'}, {'measure': 'Percentage Change From Baseline in Indication-Specific Seizure Frequency As Recorded by Caregivers', 'timeFrame': 'Day 1 up to Taper Period, up to Week 52'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From start of treatment to the post-treatment safety follow-up visit, up to 62 weeks'}, {'measure': 'Mean Change From Baseline in Blood Pressure', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Mean Change From Baseline in Pulse Rate', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Mean Change From Baseline in Respiratory Rate', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Mean Change From Baseline in Body Temperature', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Mean Change From Baseline in Height', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Mean Change From Baseline in Body Weight', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Mean Change From Baseline in Heart Rate', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Mean Change From Baseline in RR Interval', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Mean Change From Baseline in PR Interval', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Mean Change From Baseline in QRS Duration', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Mean Change From Baseline in QT Interval', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Mean Change From Baseline in QTcB and QTcF', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Number of Participants With a Clinically Significant Change in Laboratory Parameters', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Number of Participants With Emergence of New Types of Seizures', 'timeFrame': 'From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks'}, {'measure': 'Plasma Concentrations of GWP42003-P and Its Major Metabolites', 'timeFrame': 'Predose, 3 hours and 6 hours post dose at End of Treatment (Week 52)'}, {'measure': 'Number of Participants Based on Percentage Change From Baseline in Indication-Specific Total Countable Seizures as Recorded by Caregivers', 'timeFrame': 'Day 1 up to Taper Period, up to Week 52'}, {'measure': 'Clinician Global Impression of Severity (CGI/S) Score', 'timeFrame': 'At Day 365 (EOT)', 'description': 'The CGIC/S is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores are reported.\n\nThe severity of impairment in each domain is rated by the clinician in a scale of 1 through 7 where 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Higher scores indicate poor clinical outcome.'}, {'measure': 'Clinician Global Impression of Change (CGI/C) Score', 'timeFrame': 'At Day 365 (EOT)', 'description': 'The CGI/C is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores are reported.\n\nThe severity of impairment in each domain is rated by the clinician in a scale of 1 through 7 where 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Higher scores indicate poor clinical outcome.'}], 'secondaryOutcomes': [{'measure': 'Number of Treatment Responders', 'timeFrame': 'Day 1 up to the taper period, up to Week 52', 'description': 'Treatment Responders are defined as participants with ≥ 50% reduction from baseline in caregiver-reported total countable seizures'}, {'measure': 'Number of Participants Who Achieved Seizure-Free Status', 'timeFrame': 'Week 12, and every 4 weeks thereafter, up to date of withdrawal or Week 24, whichever occurs first'}, {'measure': 'Percentage of Participants Still Receiving GWP42003-P', 'timeFrame': 'Week 12, and every 4 weeks thereafter, up to date of withdrawal or Week 24, whichever occurs first'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Seizures', 'Infantile Spasms', 'Pediatric', 'Children', 'Infants', 'Cannabidiol oral solution', 'GWP42003-P', 'Tuberous Sclerosis Complex', 'TSC', 'Tuberous Sclerosis', 'Cannabidiol', 'Epidiolex', 'CBD', 'Seizure', 'Child', 'TSC1', 'TSC2', 'Tuberous Sclerosis 1', 'Tuberous Sclerosis 2', 'Lennox-Gastaut Syndrome', 'Dravet Syndrome'], 'conditions': ['Seizure in Participants With Tuberous Sclerosis Complex', 'Seizure in Participants With Dravet Syndrome', 'Seizure in Participants With Lennox-Gastaut Syndrome']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants \\< 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet syndrome (DS).', 'detailedDescription': 'The study duration will be up to approximately 62 weeks, including a 4-week screening/baseline period, a 52-week dose optimization treatment period (which includes a fixed 2-week titration period followed by flexible dose optimization), a 10-day taper period, and a safety follow-up period (4 weeks after the end-of-taper visit).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Participants with TSC (1 month to \\< 2 years of age), or DS (1 year to \\< 2 years of age), or LGS (1 year to \\< 2 years of age) within the specified age range at the time of initial informed consent.\n* Parent(s)/legal representative is/are willing and able to give informed consent for participation in the study.\n* Parent(s)/legal representative is/are willing and able (in the investigator's opinion) to comply with all study requirements (including accurate electronic participant-reported outcome \\[ePRO\\] diary completion).\n* Participants with TSC must have a diagnosis per the 2012 International Tuberous Sclerosis Complex Consensus Conference. Participants with LGS or DS must have a diagnosis that is consistent with International League Against Epilepsy (ILAE) guidelines and confirmed by the Epilepsy Study Consortium (ESCI).\n* Participants who have uncontrolled seizures, and who are currently receiving 1 or more antiseizure medication (ASMs).\n* A suitable VEEG, as available in the medical record, within 1 year of Visit 1. When a historical VEEG is not available, and if clinically indicated and appropriate (due to uncertainties or new seizures), a VEEG will be completed and read to confirm diagnosis prior to Visit 3. All VEEGs are to be read at baseline by the investigator and by an independent reviewer.\n* Has seizures which are not adequately controlled through their current ASMs, defined as ≥ 1 seizure reported on the seizure diary during the screening/baseline period\n\nKey Exclusion Criteria:\n\n* Has tumor growth which, in the opinion of the investigator, could affect participant safety.\n* Has clinically significant abnormal laboratory values, in the investigator's opinion, at screening/baseline.\n* Has clinically significant abnormalities in the electrocardiogram (ECG) measured at screening/baseline.\n* Has any concurrent cardiovascular conditions, that will, in the investigator's opinion, interfere with the ability to assess their ECGs.\n* Has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention such as sesame seed oil.\n* Has significantly impaired hepatic function prior to Visit 3, defined as:\n\n * Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × upper limit of normal (ULN) and (total bilirubin \\[TBL\\] \\> 2 × ULN or international normalized ratio \\[INR\\] \\> 1.5).\n * Serum ALT or AST \\> 5 × ULN.\n * Serum ALT or AST \\> 3 × ULN with the presence of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (\\> 5%).\n * Elevated ALT or AST should be discussed with the medical monitor prior to Visit 3; the medical monitor may allow for a confirmatory re-draw prior to Visit 3.\n* Has received another study intervention within 4 weeks prior to Visit 1 or plans to take another study intervention during the study.\n* Has any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the participant, other participants, or site staff at risk because of participation in the study, may influence the result of the study, or may affect the participant's ability to take part in the study.\n* Any clinically significant abnormalities identified following a physical examination of the participant that, in the opinion of the investigator, would jeopardize the safety of the participant if they took part in the study.\n* Has previously been enrolled into this study.\n* Has plans to travel outside their country of residence during the study, unless the participant has confirmation that the study intervention is permitted in the destination country.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT04485104', 'briefTitle': 'Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jazz Pharmaceuticals'}, 'officialTitle': 'An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled Seizures', 'orgStudyIdInfo': {'id': 'GWEP17005'}, 'secondaryIdInfos': [{'id': '2020-002132-67', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GWP42003-P', 'description': "The 52-week treatment period includes a fixed 2-week titration schedule followed by flexible dose optimization.\n\nDay 1: 5 mg/kg/day (2.5 mg/kg twice daily (b.i.d.))\n\nDay 8: 10 mg/kg/day (5 mg/kg b.i.d.)\n\nDay 15 to Week 52: Flexible dosing based on the participant's observed efficacy, safety, and tolerability per the investigator's clinical judgement. Up to a maximum of 20 mg/kg/day (10 mg/kg b.i.d.) for LGS and DS or 25 mg/kg/day (12.5 mg/kg b.i.d.) for TSC, in maximum weekly increments of 5 mg/kg/day (≤ 2.5 mg/kg b.i.d.).", 'interventionNames': ['Drug: GWP42003-P']}], 'interventions': [{'name': 'GWP42003-P', 'type': 'DRUG', 'otherNames': ['Cannabidiol', 'Epidiolex', 'Epidyolex'], 'description': 'Oral Solution', 'armGroupLabels': ['GWP42003-P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '50139', 'city': 'Florence', 'country': 'Italy', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16147', 'city': 'Genova', 'country': 'Italy', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '00165', 'city': 'Rome', 'country': 'Italy', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '08950', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'url': 'https://www.jazzpharma.com/science/clinical-trial-data-sharing', 'ipdSharing': 'YES', 'description': "In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Jazz Pharmaceuticals Research UK Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}