Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT05602818
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2022-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Soticlestat in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System (CNS) Depressant Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712808', 'term': 'soticlestat'}, {'id': 'D000525', 'term': 'Alprazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Study Director', 'organization': 'Takeda'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'TEAEs are AEs that started after the first dose of study drug administration (Day 1) up to Day 3 for Qualification Phase and up to Day 37 for Treatment Phase', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. As pre-specified in SAP, the safety data was planned to be collected and reported as per treatment dose. Here, participants "at Risk" signified participants who received the specified treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Qualification Phase: Placebo', 'description': 'Alprazolam matching placebo orally, once on Day 1 or once on Day 2 in Qualification Phase.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 2, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Qualification Phase: Alprazolam 2 mg', 'description': 'Alprazolam 2 mg, orally, once on Day 1 or once on Day 2 in Qualification Phase.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 83, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment Phase: Soticlestat 300 mg', 'description': 'Soticlestat 300 mg as a single oral dose in one of five treatment periods.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 14, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Treatment Phase: Soticlestat 600 mg', 'description': 'Soticlestat 600 mg as a single oral dose in one of five treatment periods.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 10, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Treatment Phase: Soticlestat 900 mg', 'description': 'Soticlestat 900 mg as a single oral dose in one of five treatment periods.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 9, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Treatment Phase: Alprazolam 2 mg', 'description': 'Alprazolam 2 mg as a single oral dose in one of five treatment periods.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 50, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Treatment Phase: Placebo', 'description': 'Placebo as a single oral dose in one of five treatment periods.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 8, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 44}, {'groupId': 'EG006', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Euphoric mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 59, 'numAffected': 23}, {'groupId': 'EG006', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Phase: Drug Liking (Maximum Effect [Emax]) "At This Moment" as Assessed Using Bipolar Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Phase: Soticlestat 300 mg', 'description': 'Soticlestat 300 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG001', 'title': 'Treatment Phase: Soticlestat 600 mg', 'description': 'Soticlestat 600 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG002', 'title': 'Treatment Phase: Soticlestat 900 mg', 'description': 'Soticlestat 900 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG003', 'title': 'Treatment Phase: Alprazolam 2 mg', 'description': 'Alprazolam 2 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG004', 'title': 'Treatment Phase: Placebo', 'description': 'Placebo as a single oral dose in one of five treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '57.3', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '56.5', 'spread': '1.55', 'groupId': 'OG002'}, {'value': '88.5', 'spread': '1.58', 'groupId': 'OG003'}, {'value': '55.6', 'spread': '1.63', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose', 'description': 'Drug liking ("at this moment") assessed how much a participant likes or dislikes a drug effect at the time the question was being asked. It was scored using a 0 to 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates stronger liking.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Completer Analysis Set consisted of all participants in the Completer Analysis Set, excluding those whose Drug Liking "at this moment" VAS Emax scores met the elimination criteria defined in the SAP. As pre-specified in SAP, the pharmacodynamic data was planned to be collected and reported as per the treatment dose.'}, {'type': 'SECONDARY', 'title': 'Treatment Phase: Overall Drug Liking (Emax) Assessed Using Bipolar VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Phase: Soticlestat 300 mg', 'description': 'Soticlestat 300 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG001', 'title': 'Treatment Phase: Soticlestat 600 mg', 'description': 'Soticlestat 600 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG002', 'title': 'Treatment Phase: Soticlestat 900 mg', 'description': 'Soticlestat 900 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG003', 'title': 'Treatment Phase: Alprazolam 2 mg', 'description': 'Alprazolam 2 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG004', 'title': 'Treatment Phase: Placebo', 'description': 'Placebo as a single oral dose in one of five treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '58.5', 'spread': '2.32', 'groupId': 'OG001'}, {'value': '59.5', 'spread': '2.45', 'groupId': 'OG002'}, {'value': '90.0', 'spread': '1.82', 'groupId': 'OG003'}, {'value': '58.0', 'spread': '2.17', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each Treatment Period: 12 and 24 hours post-dose', 'description': 'Overall drug liking assesses participant\'s overall experience with the drug by assessing the participant\'s overall liking for the drug. It was scored using a 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates better liking. The "overall drug liking" was an independent measure and not an "at this moment" assessment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Completer Analysis Set consisted of all participants in the Completer Analysis Set, excluding those whose Drug Liking "at this moment" VAS Emax scores met the elimination criteria defined in the SAP. As pre-specified in SAP, the pharmacodynamic data was planned to be collected and reported as per the treatment dose.'}, {'type': 'SECONDARY', 'title': 'Treatment Phase: Take Drug Again (Emax) Assessed "Overall" by Using Bipolar VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Phase: Soticlestat 300 mg', 'description': 'Soticlestat 300 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG001', 'title': 'Treatment Phase: Soticlestat 600 mg', 'description': 'Soticlestat 600 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG002', 'title': 'Treatment Phase: Soticlestat 900 mg', 'description': 'Soticlestat 900 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG003', 'title': 'Treatment Phase: Alprazolam 2 mg', 'description': 'Alprazolam 2 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG004', 'title': 'Treatment Phase: Placebo', 'description': 'Placebo as a single oral dose in one of five treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '57.6', 'spread': '2.56', 'groupId': 'OG001'}, {'value': '58.4', 'spread': '2.72', 'groupId': 'OG002'}, {'value': '92.0', 'spread': '1.46', 'groupId': 'OG003'}, {'value': '57.1', 'spread': '2.14', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each Treatment Period: 12 and 24 hours post-dose', 'description': 'Take drug again was a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It was scored using a 0 to 100-point bipolar VAS, where 0: Definitely not, 50: Neutral, 100: Definitely so. A higher score indicates stronger desire.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Completer Analysis Set consisted of all participants in the Completer Analysis Set, excluding those whose Drug Liking "at this moment" VAS Emax scores met the elimination criteria defined in the SAP. As pre-specified in SAP, the pharmacodynamic data was planned to be collected and reported as per the treatment dose.'}, {'type': 'SECONDARY', 'title': 'Treatment Phase: Bad Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Phase: Soticlestat 300 mg', 'description': 'Soticlestat 300 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG001', 'title': 'Treatment Phase: Soticlestat 600 mg', 'description': 'Soticlestat 600 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG002', 'title': 'Treatment Phase: Soticlestat 900 mg', 'description': 'Soticlestat 900 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG003', 'title': 'Treatment Phase: Alprazolam 2 mg', 'description': 'Alprazolam 2 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG004', 'title': 'Treatment Phase: Placebo', 'description': 'Placebo as a single oral dose in one of five treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '2.08', 'groupId': 'OG002'}, {'value': '28.5', 'spread': '4.71', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '0.93', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose', 'description': 'Bad drug effects assessed the bad effect of drug experienced by the participant at the time the question is being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and ranged from 0 (Not at all) to 100 (Extremely). A higher score indicated a stronger bad drug effect.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Completer Analysis Set consisted of all participants in the Completer Analysis Set, excluding those whose Drug Liking "at this moment" VAS Emax scores met the elimination criteria defined in the SAP. As pre-specified in SAP, the pharmacodynamic data was planned to be collected and reported as per the treatment dose.'}, {'type': 'SECONDARY', 'title': 'Treatment Phase: Good Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Phase: Soticlestat 300 mg', 'description': 'Soticlestat 300 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG001', 'title': 'Treatment Phase: Soticlestat 600 mg', 'description': 'Soticlestat 600 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG002', 'title': 'Treatment Phase: Soticlestat 900 mg', 'description': 'Soticlestat 900 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG003', 'title': 'Treatment Phase: Alprazolam 2 mg', 'description': 'Alprazolam 2 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG004', 'title': 'Treatment Phase: Placebo', 'description': 'Placebo as a single oral dose in one of five treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '2.78', 'groupId': 'OG001'}, {'value': '11.6', 'spread': '3.10', 'groupId': 'OG002'}, {'value': '74.0', 'spread': '3.42', 'groupId': 'OG003'}, {'value': '8.1', 'spread': '2.74', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose', 'description': 'Good drug effects assessed the good effect of drug experienced by the participant at the time the question was being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and range from 0 (Not at all) to 100 (extremely). A higher score indicated a stronger good drug effect.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Completer Analysis Set consisted of all participants in the Completer Analysis Set, excluding those whose Drug Liking "at this moment" VAS Emax scores met the elimination criteria defined in the SAP. As pre-specified in SAP, the pharmacodynamic data was planned to be collected and reported as per the treatment dose.'}, {'type': 'SECONDARY', 'title': 'Treatment Phase: High (Emax) Assessed "At This Moment" by Using Unipolar VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Phase: Soticlestat 300 mg', 'description': 'Soticlestat 300 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG001', 'title': 'Treatment Phase: Soticlestat 600 mg', 'description': 'Soticlestat 600 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG002', 'title': 'Treatment Phase: Soticlestat 900 mg', 'description': 'Soticlestat 900 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG003', 'title': 'Treatment Phase: Alprazolam 2 mg', 'description': 'Alprazolam 2 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG004', 'title': 'Treatment Phase: Placebo', 'description': 'Placebo as a single oral dose in one of five treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '2.94', 'groupId': 'OG001'}, {'value': '11.3', 'spread': '3.16', 'groupId': 'OG002'}, {'value': '72.8', 'spread': '3.49', 'groupId': 'OG003'}, {'value': '8.1', 'spread': '2.62', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose', 'description': 'High assessed the degree that a participant feels a good effect (that is, euphoria) at the time the question was being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and ranged from 0 (Not at all) to 100 (Extremely). A higher score indicated a stronger high effect.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Completer Analysis Set consisted of all participants in the Completer Analysis Set, excluding those whose Drug Liking "at this moment" VAS Emax scores met the elimination criteria defined in the SAP. As pre-specified in SAP, the pharmacodynamic data was planned to be collected and reported as per the treatment dose.'}, {'type': 'SECONDARY', 'title': 'Treatment Phase: Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Phase: Soticlestat 300 mg', 'description': 'Soticlestat 300 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG001', 'title': 'Treatment Phase: Soticlestat 600 mg', 'description': 'Soticlestat 600 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG002', 'title': 'Treatment Phase: Soticlestat 900 mg', 'description': 'Soticlestat 900 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG003', 'title': 'Treatment Phase: Alprazolam 2 mg', 'description': 'Alprazolam 2 mg as a single oral dose in one of five treatment periods.'}, {'id': 'OG004', 'title': 'Treatment Phase: Placebo', 'description': 'Placebo as a single oral dose in one of five treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug administration (Day 1) up to Day 37', 'description': 'An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event that started or worsened during or after the first dose of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all participants who received at least 1 dose of study drug in the Treatment phase. As pre-specified in SAP, the safety data was planned to be collected and reported as per treatment dose. Here, "overall number of participants analyzed" signified participants who received the specified treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Qualification Phase: Sequence 1', 'description': 'All participants received:\n\nDay 1: Alprazolam 2 milligrams (mg), Day 2: Alprazolam matching placebo. Orally with a 4-day washout between Qualification Phase and Treatment Phase.'}, {'id': 'FG001', 'title': 'Qualification Phase: Sequence 2', 'description': 'All participants received:\n\nDay 1: Alprazolam matching placebo, Day 2: Alprazolam 2 mg. Orally with a 4-day washout between Qualification Phase and Treatment Phase.'}, {'id': 'FG002', 'title': 'Treatment Phase, Sequence 1: ABECD', 'description': 'All participants received:\n\nPeriod 1: Soticlestat 300 milligrams (mg) (Treatment A), Period 2: Soticlestat 600 mg (Treatment B), Period 3: Placebo (Treatment E), Period 4: Soticlestat 900 mg (Treatment C), Period 5: Alprazolam 2 mg (Treatment D). Orally with a 7-day washout between doses.'}, {'id': 'FG003', 'title': 'Treatment Phase, Sequence 2: BCADE', 'description': 'All participants received:\n\nPeriod 1: Soticlestat 600 mg (Treatment B), Period 2: Soticlestat 900 mg (Treatment C), Period 3: Soticlestat 300 mg (Treatment A), Period 4: Alprazolam 2 mg (Treatment D), Period 5: Placebo (Treatment E). Orally with a 7-day washout between doses.'}, {'id': 'FG004', 'title': 'Treatment Phase, Sequence 3: CDBEA', 'description': 'All participants received:\n\nPeriod 1: Soticlestat 900 mg (Treatment C), Period 2: Alprazolam 2 mg (Treatment D), Period 3: Soticlestat 600 mg (Treatment B), Period 4: Placebo (Treatment E), Period 5: Soticlestat 300 mg (Treatment A). Orally with a 7-day washout between doses.'}, {'id': 'FG005', 'title': 'Treatment Phase, Sequence 4: DECAB', 'description': 'Period 1: Alprazolam 2 mg (Treatment D), Period 2: Placebo (Treatment E), Period 3: Soticlestat 900 mg (Treatment C), Period 4: Soticlestat 300 mg (Treatment A), Period 5: Soticlestat 600 mg (Treatment B). Orally with a 7-day washout between doses.'}, {'id': 'FG006', 'title': 'Treatment Phase, Sequence 5: EADBC', 'description': 'All participants received:\n\nPeriod 1: Placebo (Treatment E), Period 2: Soticlestat 300 mg (Treatment A), Period 3: Alprazolam 2 mg (Treatment D), Period 4: Soticlestat 600 mg (Treatment B), Period 5: Soticlestat 900 mg (Treatment C). Orally with a 7-day washout between doses.'}, {'id': 'FG007', 'title': 'Treatment Phase, Sequence 6: DCEBA', 'description': 'All participants received:\n\nPeriod 1: Alprazolam 2 mg (Treatment D), Period 2: Soticlestat 900 mg (Treatment C), Period 3: Placebo, (Treatment E), Period 4: Soticlestat 600 mg, (Treatment B), Period 5: Soticlestat 300 mg (Treatment A). Orally with a 7-day washout between doses.'}, {'id': 'FG008', 'title': 'Treatment Phase, Sequence 7: EDACB', 'description': 'All participants received:\n\nPeriod 1: Placebo (Treatment E), Period 2: Alprazolam 2 mg (Treatment D), Period 3: Soticlestat 300 mg (Treatment A), Period 4: Soticlestat 900 mg (Treatment C), Period 5: Soticlestat 600 mg (Treatment B). Orally with a 7-day washout between doses.'}, {'id': 'FG009', 'title': 'Treatment Phase, Sequence 8: AEBDC', 'description': 'All participants received:\n\nPeriod 1: Soticlestat 300 mg (Treatment A), Period 2: Placebo (Treatment E), Period 3: Soticlestat 600 mg (Treatment B), Period 4: Alprazolam 2 mg (Treatment D), Period 5: Soticlestat 900 mg (Treatment C). Orally with a 7-day washout between doses.'}, {'id': 'FG010', 'title': 'Treatment Phase, Sequence 9: BACED', 'description': 'All participants received:\n\nPeriod 1: Soticlestat 600 mg (Treatment B), Period 2: Soticlestat 300 mg (Treatment A), Period 3: Soticlestat 900 mg (Treatment C), Period 4: Placebo (Treatment E), Period 5: Alprazolam 2 mg (Treatment D). Orally with a 7-day washout between doses.'}, {'id': 'FG011', 'title': 'Treatment Phase, Sequence 10: CBDAE', 'description': 'All participants received:\n\nPeriod 1: Soticlestat 900 mg (Treatment C), Period 2: Soticlestat 600 mg (Treatment B), Period 3: Alprazolam 2 mg (Treatment D), Period 4: Soticlestat 300 mg (Treatment A), Period 5: Placebo (Treatment E). Orally with a 7-day washout between doses.'}], 'periods': [{'title': 'Qualification Phase (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Qualification Safety Analysis Set (Treated)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Did Not Meet Qualification Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Failure to Meet Continuation Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Treatment Phase (29 Days)', 'milestones': [{'type': 'STARTED', 'comment': 'Participants who completed Qualification Phase and met the qualification criteria were randomized to Treatment Phase. However, one participant was lost to follow-up after meeting the Qualification criteria and was not randomized in Treatment Phase.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '8'}, {'groupId': 'FG011', 'numSubjects': '7'}]}, {'type': 'Safety Analysis Set (Treated)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '7'}, {'groupId': 'FG011', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 1 investigative site in the United States from 15 November 2022 to 07 July 2023. A total of 100 participants participated in the Qualification Phase, of which 69 met the qualification criteria, out of which 68 enrolled in the treatment phase and were randomized to 1 of the 10 sequences of the Treatment Phase.', 'preAssignmentDetails': 'Participants entered a Qualification Phase to determine if they were able to discriminate the drug effects of the positive control, alprazolam, when compared with placebo. Only participants who could discriminate the drug effects of the positive control were randomized into one of the 10 sequences of Treatment Phase (ABECD, BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED or CBDAE) to receive soticlestat, alprazolam or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Qualification Phase: All Participants', 'description': 'All participants who received at least 1 dose of study drug in the Qualification phase.:\n\nSequence 1, Day 1: Alprazolam 2 mg, Day 2: Alprazolam matching placebo. Sequence 2, Day 1: Alprazolam matching placebo, Day 2: Alprazolam 2 mg. Orally with a 4-day washout between Qualification Phase and Treatment Phase.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'spread': '7.16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Qualification safety analysis set consists of all participants who received at least 1 dose of study drug in the qualification phase. As pre-specified in statistical analysis plan (SAP), the combined overall data for baseline measures were planned to be collected and reported for qualification phase.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-15', 'size': 2765940, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-28T08:34', 'hasProtocol': True}, {'date': '2023-08-10', 'size': 1985867, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-28T08:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2022-10-28', 'resultsFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2022-10-28', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-24', 'studyFirstPostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Phase: Drug Liking (Maximum Effect [Emax]) "At This Moment" as Assessed Using Bipolar Visual Analogue Scale (VAS)', 'timeFrame': 'Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose', 'description': 'Drug liking ("at this moment") assessed how much a participant likes or dislikes a drug effect at the time the question was being asked. It was scored using a 0 to 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates stronger liking.'}], 'secondaryOutcomes': [{'measure': 'Treatment Phase: Overall Drug Liking (Emax) Assessed Using Bipolar VAS', 'timeFrame': 'Day 1 of each Treatment Period: 12 and 24 hours post-dose', 'description': 'Overall drug liking assesses participant\'s overall experience with the drug by assessing the participant\'s overall liking for the drug. It was scored using a 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates better liking. The "overall drug liking" was an independent measure and not an "at this moment" assessment.'}, {'measure': 'Treatment Phase: Take Drug Again (Emax) Assessed "Overall" by Using Bipolar VAS', 'timeFrame': 'Day 1 of each Treatment Period: 12 and 24 hours post-dose', 'description': 'Take drug again was a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It was scored using a 0 to 100-point bipolar VAS, where 0: Definitely not, 50: Neutral, 100: Definitely so. A higher score indicates stronger desire.'}, {'measure': 'Treatment Phase: Bad Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS', 'timeFrame': 'Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose', 'description': 'Bad drug effects assessed the bad effect of drug experienced by the participant at the time the question is being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and ranged from 0 (Not at all) to 100 (Extremely). A higher score indicated a stronger bad drug effect.'}, {'measure': 'Treatment Phase: Good Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS', 'timeFrame': 'Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose', 'description': 'Good drug effects assessed the good effect of drug experienced by the participant at the time the question was being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and range from 0 (Not at all) to 100 (extremely). A higher score indicated a stronger good drug effect.'}, {'measure': 'Treatment Phase: High (Emax) Assessed "At This Moment" by Using Unipolar VAS', 'timeFrame': 'Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose', 'description': 'High assessed the degree that a participant feels a good effect (that is, euphoria) at the time the question was being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and ranged from 0 (Not at all) to 100 (Extremely). A higher score indicated a stronger high effect.'}, {'measure': 'Treatment Phase: Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From start of study drug administration (Day 1) up to Day 37', 'description': 'An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event that started or worsened during or after the first dose of study drug.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://classic.clinicaltrials.gov/ct2/bye/kQoPWwoRrXS90dhzuQ7gkdoPSQ7GvwSxWB7mz6hjuBc9mX-gWi7PxX7PzihGedY9kRh8EB76k6NjLK7jWKCtOscz5PNzvihHSsD8LVp8SRzP3DSWxRF8mRCtaRp8SRp8LPt/3HhqJdcyWB7zunhLZwN8JQ7xNd-ymB1PedcOJdcOJihkznogWi7PxXY30dhz0QS3l61yzXc9unoPlQ1RJdhzuQSO', 'label': 'To obtain more information on the study, click here/on this link.'}]}, 'descriptionModule': {'briefSummary': 'The main aim is to evaluate the relative abuse potential of soticlestat in healthy adults who has used central nervous system (CNS) depressants for recreational nontherapeutic reasons.', 'detailedDescription': 'The drug being tested in this study is called soticlestat. Soticlestat is being tested in healthy participants. This study will assess the relative abuse potential of soticlestat compared to alprazolam and placebo in healthy adult, nondependent recreational drug users with CNS depressant experience. The study will enroll approximately 110 participants. Participants will be randomly (by chance, like flipping a coin) assigned to treatments of the study.\n\nTreatment order will remain undisclosed to the participants and study doctor (unless there is an urgent medical need). This single center trial will be conducted in the United States. Participants will be followed up for up to 7 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 11 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Healthy as determined by the investigator.\n2. Current CNS depressant user who has used CNS depressants (example, benzodiazepines, barbiturates, zolpidem, eszopiclone, zopiclone, propofol/fospropofol, gamma-hydroxybutyrate) for recreational, nontherapeutic reasons at least 10 times in their lifetime and at least once in the 12 weeks prior to screening. Participant must also have recreational experience with at least 1 other drug class associated with abuse (example, opioids, stimulants, cannabinoids, hallucinogens, dissociatives) at least 10 times in their lifetime.\n3. Body mass index (BMI) of 18.5 to 35.0 kilogram per square meter (kg/m\\^2), inclusive, and a minimum body weight of 50.0 Kilogram (kg) at screening.\n\nExclusion Criteria\n\n1. Self-reported history of drug or alcohol dependence (within the past 1 year, except caffeine or nicotine, prior to the screening visit).\n2. Positive alcohol breathalyzer or urine drug screen (UDS) for substances of abuse at admission, excluding tetrahydrocannabinol (THC).\n3. Heavy smoker or user of other types of nicotine products (greater than \\[\\>\\] 20 cigarettes equivalent per day).\n4. Unable to abstain from smoking for at least 2 hours before and at least 8 hours after dosing.\n5. Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.'}, 'identificationModule': {'nctId': 'NCT05602818', 'briefTitle': 'A Study of Soticlestat in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System (CNS) Depressant Experience', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 5-Way Crossover Study Evaluating the Abuse Potential of Soticlestat (TAK-935) in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System Depressant Experience', 'orgStudyIdInfo': {'id': 'TAK-935-1012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Soticlestat 300 mg', 'description': 'Participants will receive a single oral dose of soticlestat 300 milligrams (mg).', 'interventionNames': ['Drug: Soticlestat 300 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Soticlestat 600 mg', 'description': 'Participants will receive a single oral dose of soticlestat 600 mg.', 'interventionNames': ['Drug: Soticlestat 600 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Soticlestat 900 mg', 'description': 'Participants will receive a single oral dose of soticlestat 900 mg.', 'interventionNames': ['Drug: Soticlestat 900 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alprazolam 2 mg', 'description': 'Participants will receive a single oral dose of over encapsulated alprazolam 2 mg.', 'interventionNames': ['Drug: Alprazolam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a single oral dose of matching placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Soticlestat 300 mg', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Soticlestat 300 mg']}, {'name': 'Soticlestat 600 mg', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Soticlestat 600 mg']}, {'name': 'Soticlestat 900 mg', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Soticlestat 900 mg']}, {'name': 'Alprazolam', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Alprazolam 2 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Altasciences', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}