Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-28 @ 9:03 PM
Study NCT ID:
NCT03286218
Status:
COMPLETED
Last Update Posted:
2020-01-10
First Post:
2017-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084783', 'term': 'Recreational Drug Use'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C554777', 'term': 'lasmiditan'}, {'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': 'ClinicalTrials.gov@lilly.com', 'phone': '(800) 545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline to Study Completion (Up to 2 months)', 'description': 'All randomized participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Qualification Phase - Placebo', 'description': 'Placebo was administered orally.', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 8, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Qualification Phase - Alprazolam', 'description': '1 mg of alprazolam was administered orally.', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 74, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment Phase - Placebo', 'description': 'Placebo was administered orally in one of five treatment periods.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 12, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Treatment Phase - 2 mg Alprazolam', 'description': '2 mg alprazolam was administered orally in one of five treatment periods.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 49, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Treatment Phase - 100 mg Lasmiditan', 'description': '100 mg of Lasmiditan was administered orally in one of five treatment periods.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 33, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Treatment Phase - 200 mg Lasmiditan', 'description': '200 mg of Lasmiditan was administered orally in one of five treatment periods.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 42, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Treatment Phase - 400 mg Lasmiditan', 'description': '400 mg of Lasmiditan was administered orally in one of five treatment periods.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 47, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Feeling of relaxation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 52, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 45, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Euphoric mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered orally in one of five treatment periods.'}, {'id': 'OG001', 'title': 'Alprazolam - 2 mg', 'description': '2 mg of Alprazolam administered orally in one of five treatment periods'}, {'id': 'OG002', 'title': 'Lasmiditan - 100 mg', 'description': '100 mg of lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG003', 'title': 'Lasmiditan - 200 mg', 'description': '200 mg of lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG004', 'title': 'Lasmiditan - 400 mg', 'description': '400 mg of lasmiditan administered orally in one of five treatment periods'}], 'classes': [{'categories': [{'measurements': [{'value': '53.0', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '85.4', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '68.6', 'spread': '1.94', 'groupId': 'OG002'}, {'value': '73.3', 'spread': '1.94', 'groupId': 'OG003'}, {'value': '76.6', 'spread': '1.94', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '32.4', 'ciLowerLimit': '28.4', 'ciUpperLimit': '36.4', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 14 mm.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '15.6', 'ciLowerLimit': '11.7', 'ciUpperLimit': '19.6', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '20.3', 'ciLowerLimit': '16.3', 'ciUpperLimit': '24.3', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '23.6', 'ciLowerLimit': '19.6', 'ciUpperLimit': '27.6', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '16.8', 'ciLowerLimit': '12.8', 'ciUpperLimit': '20.8', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority (NI) margin for Alprazolam and Lasmiditan 100 mg dose is 5 mm.'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '12.1', 'ciLowerLimit': '8.10', 'ciUpperLimit': '16.1', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority (NI) margin for Alprazolam and Lasmiditan 200 mg dose is 5 mm.'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '8.79', 'ciLowerLimit': '4.8', 'ciUpperLimit': '12.8', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority (NI) margin for Alprazolam and Lasmiditan 400 mg dose is 5 mm.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Each Phase: 24 Hours', 'description': 'The Emax of Bipolar Drug Liking VAS Scores were derived as the maximum at-the-moment Drug Liking VAS score where the time to Emax was the corresponding time point at which the maximum score occurred. The bipolar Drug Liking VAS is consistent with FDA Guidance (January 2017) such that placebo should produce a score between 40 and 60 representing neutral drug-liking (ie, neither like nor dislike); a score ranging from 0 to 100 and a score of 0 indicates strong disliking, and a score of 100 indicates strong liking. Least squares mean (LS mean) was calculated using a linear mixed-effects model, including period, sequence, and treatment as fixed effects, and subject as a random effect, was used to evaluate the hypothesis tests of primary interest (at-the-moment Drug Liking) at the Emax.', 'unitOfMeasure': 'millimeter (mm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug had evaluable PD data in each of the 5 periods.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lasmiditan - 100 mg', 'description': '100 mg of lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG001', 'title': 'Lasmiditan - 200 mg', 'description': '200 of lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG002', 'title': 'Lasmiditan - 400 mg', 'description': '400 mg of lasmiditan administered orally in one of five treatment periods'}], 'classes': [{'categories': [{'measurements': [{'value': '132', 'spread': '37', 'groupId': 'OG000'}, {'value': '299', 'spread': '35', 'groupId': 'OG001'}, {'value': '689', 'spread': '34', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose', 'description': 'Pharmacokinetics (PK) defined as the maximum observed drug concentration (Cmax) of lasmiditan', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lasmiditan - 100 mg', 'description': '100 mg lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG001', 'title': 'Lasmiditan - 200 mg', 'description': '200 mg of lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG002', 'title': 'Lasmiditan - 400 mg Dose', 'description': '400 of lasmiditan administered orally in one of five treatment periods'}], 'classes': [{'categories': [{'measurements': [{'value': '856', 'spread': '32', 'groupId': 'OG000'}, {'value': '1810', 'spread': '35', 'groupId': 'OG001'}, {'value': '3920', 'spread': '28', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose', 'description': 'PK defined as the area under the curve of lasmiditan from zero to infinity (AUC\\[0-∞\\])', 'unitOfMeasure': 'nanogram*hour/milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered orally in one of five treatment periods.'}, {'id': 'OG001', 'title': 'Alprazolam - 2 mg', 'description': '2 mg of Alprazolam administered orally in one of five treatment periods'}, {'id': 'OG002', 'title': 'Lasmiditan - 100 mg', 'description': '100 mg of lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG003', 'title': 'Lasmiditan - 200 mg', 'description': '200 mg of lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG004', 'title': 'Lasmiditan - 400 mg', 'description': '400 mg of lasmiditan administered orally in one of five treatment periods'}], 'classes': [{'title': 'Overall Drug Liking', 'categories': [{'measurements': [{'value': '53.1', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '86.2', 'spread': '2.41', 'groupId': 'OG001'}, {'value': '71.7', 'spread': '2.41', 'groupId': 'OG002'}, {'value': '72.2', 'spread': '2.41', 'groupId': 'OG003'}, {'value': '77.4', 'spread': '2.41', 'groupId': 'OG004'}]}]}, {'title': 'Take Drug Again', 'categories': [{'measurements': [{'value': '52.0', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '86.0', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '71.1', 'spread': '2.70', 'groupId': 'OG002'}, {'value': '72.7', 'spread': '2.70', 'groupId': 'OG003'}, {'value': '77.3', 'spread': '2.70', 'groupId': 'OG004'}]}]}, {'title': 'Good Effects', 'categories': [{'measurements': [{'value': '10.8', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '80.5', 'spread': '4.10', 'groupId': 'OG001'}, {'value': '46.4', 'spread': '4.10', 'groupId': 'OG002'}, {'value': '62.9', 'spread': '4.10', 'groupId': 'OG003'}, {'value': '63.8', 'spread': '4.10', 'groupId': 'OG004'}]}]}, {'title': 'Bad Effects', 'categories': [{'measurements': [{'value': '2.47', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '3.22', 'groupId': 'OG001'}, {'value': '7.51', 'spread': '3.22', 'groupId': 'OG002'}, {'value': '9.75', 'spread': '3.22', 'groupId': 'OG003'}, {'value': '15.0', 'spread': '3.22', 'groupId': 'OG004'}]}]}, {'title': 'Any Effects', 'categories': [{'measurements': [{'value': '8.35', 'spread': '4.05', 'groupId': 'OG000'}, {'value': '83.7', 'spread': '4.05', 'groupId': 'OG001'}, {'value': '53.3', 'spread': '4.05', 'groupId': 'OG002'}, {'value': '65.1', 'spread': '4.05', 'groupId': 'OG003'}, {'value': '73.2', 'spread': '4.04', 'groupId': 'OG004'}]}]}, {'title': 'High', 'categories': [{'measurements': [{'value': '8.61', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '77.2', 'spread': '3.89', 'groupId': 'OG001'}, {'value': '43.0', 'spread': '3.89', 'groupId': 'OG002'}, {'value': '56.1', 'spread': '3.89', 'groupId': 'OG003'}, {'value': '67.0', 'spread': '3.89', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '33.1', 'ciLowerLimit': '28.5', 'ciUpperLimit': '37.7', 'groupDescription': 'Overall Drug Liking', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '18.6', 'ciLowerLimit': '14.0', 'ciUpperLimit': '23.2', 'groupDescription': 'Overall Drug Liking', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '19.1', 'ciLowerLimit': '14.5', 'ciUpperLimit': '23.8', 'groupDescription': 'Overall Drug Liking', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '24.3', 'ciLowerLimit': '19.7', 'ciUpperLimit': '28.9', 'groupDescription': 'Overall Drug Liking', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '34.0', 'ciLowerLimit': '29.1', 'ciUpperLimit': '38.9', 'groupDescription': 'Take drug again', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '19.1', 'ciLowerLimit': '14.2', 'ciUpperLimit': '24.0', 'groupDescription': 'Take drug again', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '20.6', 'ciLowerLimit': '15.7', 'ciUpperLimit': '25.6', 'groupDescription': 'Take drug again', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '25.3', 'ciLowerLimit': '20.3', 'ciUpperLimit': '30.2', 'groupDescription': 'Take drug again', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '69.7', 'ciLowerLimit': '62.1', 'ciUpperLimit': '77.4', 'groupDescription': 'Good effects', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '35.5', 'ciLowerLimit': '27.9', 'ciUpperLimit': '43.2', 'groupDescription': 'Good effects', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '52.0', 'ciLowerLimit': '44.4', 'ciUpperLimit': '59.7', 'groupDescription': 'Good effects', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '53.0', 'ciLowerLimit': '45.4', 'ciUpperLimit': '60.6', 'groupDescription': 'Good effects', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '20.4', 'ciLowerLimit': '13.6', 'ciUpperLimit': '27.2', 'groupDescription': 'Bad effects', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.04', 'ciLowerLimit': '-1.76', 'ciUpperLimit': '11.8', 'groupDescription': 'Bad effects', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.28', 'ciLowerLimit': '0.487', 'ciUpperLimit': '14.1', 'groupDescription': 'Bad effects', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '12.5', 'ciLowerLimit': '5.69', 'ciUpperLimit': '19.3', 'groupDescription': 'Bad effects', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '75.4', 'ciLowerLimit': '67.2', 'ciUpperLimit': '83.5', 'groupDescription': 'Any effects', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '44.9', 'ciLowerLimit': '36.8', 'ciUpperLimit': '53.0', 'groupDescription': 'Any effects', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '56.8', 'ciLowerLimit': '48.7', 'ciUpperLimit': '64.9', 'groupDescription': 'Any effects', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '64.8', 'ciLowerLimit': '56.7', 'ciUpperLimit': '73.0', 'groupDescription': 'Any effects', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '68.6', 'ciLowerLimit': '60.6', 'ciUpperLimit': '76.6', 'groupDescription': 'High', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '34.4', 'ciLowerLimit': '26.4', 'ciUpperLimit': '42.4', 'groupDescription': 'High', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '47.5', 'ciLowerLimit': '39.5', 'ciUpperLimit': '55.5', 'groupDescription': 'High', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '58.4', 'ciLowerLimit': '50.4', 'ciUpperLimit': '66.3', 'groupDescription': 'High', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose', 'description': 'Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. Scales include: Overall drug liking (overall, my liking for this drug is) and ranges from 0 definitely not to 100 definitely so. Take Drug Again (I would take this drug again) and ranges from 0 definitely not to 100 definitely so. Good effects (I can feel good drug effects) and ranges from 0 definitely not to 100 definitely so. Bad effects (I can feel bad drug effects) and ranges from 0 definitely not to 100 definitely so. High (I am feeling) and ranges from 0 not at all high to 100 extremely high. Emax is derived as the maximum score across all postdose time points for each participant. Least Square (LS) Mean is calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.'}, {'type': 'SECONDARY', 'title': 'PD: Maximal Drug Effects (Emax) VAS (Hallucinations)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered orally in one of five treatment periods.'}, {'id': 'OG001', 'title': 'Alprazolam - 2 mg', 'description': '2 mg of Alprazolam administered orally in one of five treatment periods'}, {'id': 'OG002', 'title': 'Lasmiditan - 100 mg', 'description': '100 mg of lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG003', 'title': 'Lasmiditan - 200 mg', 'description': '200 mg of lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG004', 'title': 'Lasmiditan - 400 mg', 'description': '400 mg of lasmiditan administered orally in one of five treatment periods'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1.00'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0781', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0625', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0098', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose', 'description': 'Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The hallucinations scale is presented meaning (I am hallucinating) and ranges from 0 not at all to 100 extremely. Emax is derived as the maximum score across all postdose time points for each participant. Median and interquartile range are reported for each treatment group.', 'unitOfMeasure': 'mm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.'}, {'type': 'SECONDARY', 'title': 'PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered orally in one of five treatment periods.'}, {'id': 'OG001', 'title': 'Alprazolam - 2 mg', 'description': '2 mg of Alprazolam administered orally in one of five treatment periods'}, {'id': 'OG002', 'title': 'Lasmiditan - 100 mg', 'description': '100 mg of lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG003', 'title': 'Lasmiditan - 200 mg', 'description': '200 mg of lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG004', 'title': 'Lasmiditan - 400 mg', 'description': '400 mg of lasmiditan administered orally in one of five treatment periods'}], 'classes': [{'title': 'Alertness/drowsiness', 'categories': [{'measurements': [{'value': '42.5', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '1.97', 'groupId': 'OG001'}, {'value': '25.6', 'spread': '1.97', 'groupId': 'OG002'}, {'value': '22.9', 'spread': '1.97', 'groupId': 'OG003'}, {'value': '17.7', 'spread': '1.97', 'groupId': 'OG004'}]}]}, {'title': 'Agitation/relaxation', 'categories': [{'measurements': [{'value': '44.1', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '24.6', 'spread': '1.94', 'groupId': 'OG002'}, {'value': '22.4', 'spread': '1.94', 'groupId': 'OG003'}, {'value': '15.4', 'spread': '1.94', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-29.9', 'ciLowerLimit': '-34.0', 'ciUpperLimit': '-25.9', 'groupDescription': 'Alertness/drowsiness', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-16.9', 'ciLowerLimit': '-20.9', 'ciUpperLimit': '-12.8', 'groupDescription': 'Alertness/drowsiness', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-19.6', 'ciLowerLimit': '-23.6', 'ciUpperLimit': '-15.5', 'groupDescription': 'Alertness/drowsiness', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-24.8', 'ciLowerLimit': '-28.8', 'ciUpperLimit': '-20.8', 'groupDescription': 'Alertness/drowsiness', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-30.8', 'ciLowerLimit': '-35.0', 'ciUpperLimit': '-26.5', 'groupDescription': 'Agitation/relaxation', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-19.5', 'ciLowerLimit': '-23.7', 'ciUpperLimit': '-15.3', 'groupDescription': 'Agitation/relaxation', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-21.7', 'ciLowerLimit': '-25.9', 'ciUpperLimit': '-17.5', 'groupDescription': 'Agitation/relaxation', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-28.8', 'ciLowerLimit': '-33.0', 'ciUpperLimit': '-24.5', 'groupDescription': 'Agitation/relaxation', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Each Phase:Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose', 'description': 'Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The scales included: Alertness/Drowsiness (I am feeling) ranges from 0 very drowsy to 100 very alert. Agitation/Relaxation (my mood is) and ranges from 0 very relaxed to 100 very agitated. Emin is derived across all postdose time points for each participant. LS Mean was calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.'}, {'type': 'SECONDARY', 'title': 'PD: Mean Scores on Drug Similarity VAS Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Qualification Phase', 'description': 'Placebo was administered orally in one of 2 treatment periods.'}, {'id': 'OG001', 'title': '1 mg Alprazolam - Qualification Phase', 'description': '1 mg of Alprazolam was administered orally in one of 2 treatment periods.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered orally in one of five treatment periods.'}, {'id': 'OG003', 'title': '2 mg Alprazolam', 'description': '2 mg of Alprazolam was administered orally in one of five treatment periods.'}, {'id': 'OG004', 'title': 'Lasmiditan - 100 mg', 'description': '100 mg of lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG005', 'title': 'Lasmiditan - 200 mg', 'description': '200 mg of lasmiditan administered orally in one of five treatment periods'}, {'id': 'OG006', 'title': 'Lasmiditan - 400 mg', 'description': '400 mg of lasmiditan administered orally in one of five treatment periods'}], 'classes': [{'title': 'How similar with cocaine /', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '27', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '6.6', 'groupId': 'OG002'}, {'value': '6.1', 'spread': '13.6', 'groupId': 'OG003'}, {'value': '2.7', 'spread': '4.2', 'groupId': 'OG004'}, {'value': '14.6', 'spread': '26.3', 'groupId': 'OG005'}, {'value': '12.5', 'spread': '23.3', 'groupId': 'OG006'}]}]}, {'title': 'How similar with caffeine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}, {'value': '43', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '7.2', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '9.7', 'groupId': 'OG003'}, {'value': '2.2', 'spread': '2.4', 'groupId': 'OG004'}, {'value': '4.4', 'spread': '9.8', 'groupId': 'OG005'}, {'value': '4.1', 'spread': '8.3', 'groupId': 'OG006'}]}]}, {'title': 'How similar to MDMA (Ectasy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '20.4', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '3.9', 'groupId': 'OG002'}, {'value': '20.5', 'spread': '23.7', 'groupId': 'OG003'}, {'value': '10.6', 'spread': '19.9', 'groupId': 'OG004'}, {'value': '17.1', 'spread': '28.2', 'groupId': 'OG005'}, {'value': '18.7', 'spread': '28.2', 'groupId': 'OG006'}]}]}, {'title': 'How similar to amphetamine or methamphetamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '6.0', 'groupId': 'OG002'}, {'value': '3.9', 'spread': '5.5', 'groupId': 'OG003'}, {'value': '2.3', 'spread': '2.5', 'groupId': 'OG004'}, {'value': '4.6', 'spread': '4.8', 'groupId': 'OG005'}, {'value': '4.4', 'spread': '6.2', 'groupId': 'OG006'}]}]}, {'title': 'How similar to phencyclidine (PCP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '22.0', 'spread': '30.6', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '26.7', 'spread': '40.3', 'groupId': 'OG003'}, {'value': '1.3', 'spread': '1.5', 'groupId': 'OG004'}, {'value': '24.0', 'spread': '37.3', 'groupId': 'OG005'}, {'value': '32.3', 'spread': '43.7', 'groupId': 'OG006'}]}]}, {'title': 'How similar to codeine or morphine use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '11.4', 'spread': '23.8', 'groupId': 'OG000'}, {'value': '41.5', 'spread': '35.1', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '21.7', 'groupId': 'OG002'}, {'value': '50.8', 'spread': '31.2', 'groupId': 'OG003'}, {'value': '30.9', 'spread': '30.4', 'groupId': 'OG004'}, {'value': '37.6', 'spread': '31.7', 'groupId': 'OG005'}, {'value': '45.9', 'spread': '32.4', 'groupId': 'OG006'}]}]}, {'title': 'How similar to (lysergic acid diethylamide (LSD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '6.6', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '7.5', 'groupId': 'OG003'}, {'value': '3.5', 'spread': '4.6', 'groupId': 'OG004'}, {'value': '5.9', 'spread': '5.5', 'groupId': 'OG005'}, {'value': '7.2', 'spread': '8.0', 'groupId': 'OG006'}]}]}, {'title': 'How similar to nicotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '9.6', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '5.5', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '9.4', 'groupId': 'OG003'}, {'value': '3.3', 'spread': '11.0', 'groupId': 'OG004'}, {'value': '3.6', 'spread': '9.0', 'groupId': 'OG005'}, {'value': '4.3', 'spread': '8.6', 'groupId': 'OG006'}]}]}, {'title': 'How similar to cannabis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '33.5', 'groupId': 'OG001'}, {'value': '8.9', 'spread': '22.9', 'groupId': 'OG002'}, {'value': '51.2', 'spread': '30.3', 'groupId': 'OG003'}, {'value': '29.9', 'spread': '30.0', 'groupId': 'OG004'}, {'value': '37.4', 'spread': '29.6', 'groupId': 'OG005'}, {'value': '41.7', 'spread': '31.6', 'groupId': 'OG006'}]}]}, {'title': 'How similar to benzodiazepine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '14.4', 'spread': '32.4', 'groupId': 'OG000'}, {'value': '75.9', 'spread': '36.2', 'groupId': 'OG001'}, {'value': '13.1', 'spread': '30.6', 'groupId': 'OG002'}, {'value': '88.1', 'spread': '22.6', 'groupId': 'OG003'}, {'value': '57.2', 'spread': '40.3', 'groupId': 'OG004'}, {'value': '66.9', 'spread': '38.7', 'groupId': 'OG005'}, {'value': '74.6', 'spread': '31.9', 'groupId': 'OG006'}]}]}, {'title': 'How similar to mushrooms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '5.2', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '6.1', 'groupId': 'OG003'}, {'value': '2.1', 'spread': '2.1', 'groupId': 'OG004'}, {'value': '3.8', 'spread': '5.7', 'groupId': 'OG005'}, {'value': '4.9', 'spread': '6.3', 'groupId': 'OG006'}]}]}, {'title': 'How similar to heroin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '38.1', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean and standard deviation are not calculated due to N=2, minimum and maximum values are reported: minimum value is 0 and maximum value is 0.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean and standard deviation are not calculated due to N=2, minimum and maximum values are reported: minimum value is 0 and maximum value is 79.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean and standard deviation are not calculated due to N=2, minimum and maximum values are reported: minimum value is 0 and maximum value is 3.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean and standard deviation are not calculated due to N=2, minimum and maximum values are reported: minimum value is 2 and maximum value is 60.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean and standard deviation are not calculated due to N=2, minimum and maximum values are reported: minimum value is 2 and maximum value is 96.', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Each Phase: 24 Hours Post Dose', 'description': 'Participants marked a point on a 100-mm horizontal line that best represented their response to the given question. The endpoints of each electronic scale were marked with descriptive anchors on a scale from 0 to 100 (Fraser et al. 1961; Bond and Lader 1974; Bigelow 1991; Shram et al. 2010). In the "How similar" questions, ranges from 0 to 100 and a score of 0 indicates definitely not similar, and a score of 100 indicates definitely similar.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug, were familiar with each listed drug on the questionnaire and had evaluable data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Qualification Phase - Alprazolam Then Placebo Sequence 1', 'description': 'Sequence 1 - One tablet of 1 milligram (mg) alprazolam was administered orally in period 1 then placebo period 2.'}, {'id': 'FG001', 'title': 'Qualification Phase - Placebo Then Alprazolam (Alp) Sequence 2', 'description': 'Sequence 2 - Placebo was administered orally period 1 then one tablet of 2 mg alprazolam period 2.'}, {'id': 'FG002', 'title': 'Sequence 1', 'description': 'Sequence 1, Periods 1 - 5: (Placebo, 100 mg Las, 2 mg Alp, 200 mg Las, then 400 mg Las)\n\nAll participants received:\n\nPeriod 1: Placebo Period 2: 100 mg Las Period 3: 200 mg Las Period 4: 400 mg Las Period 5: 2 mg Alp\n\nOrally with a 3 day washout between doses.'}, {'id': 'FG003', 'title': 'Sequence 2', 'description': 'Sequence 2 , Periods 1 - 5: (100 mg Las, 200 mg Las, Placebo, 400 mg Las, then 2 mg Alp)\n\nAll participants received:\n\nPeriod 1: 100 mg Las Period 2: 200 mg Las Period 3: Placebo Period 4: 400 mg Las Period 5: 2 mg Alp\n\nOrally with a 3 day washout between doses.'}, {'id': 'FG004', 'title': 'Sequence 3', 'description': 'Sequence 3, Periods 1 - 5: (200 mg Las, 400 mg Las, 100 mg Las, 2 mg Alp, then Placebo)\n\nAll participants received:\n\nPeriod 1: 200 mg Las Period 2: 400 mg Las Period 3: 100 mg Las Period 4: 2 mg Las Period 5: Placebo\n\nOrally with a 3 day washout between doses.'}, {'id': 'FG005', 'title': 'Sequence 4', 'description': 'Sequence 4, Periods 1 - 5: (400 mg Las, 2 mg Alp, 200 mg Las, Placebo, then 100 mg Las)\n\nAll participants received:\n\nPeriod 1: 400 mg Las Period 2: 2 mg Alp Period 3: 200 mg Las Period 4: Placebo Period 5: 100 mg Las\n\nOrally with a 3 day washout between doses.'}, {'id': 'FG006', 'title': 'Sequence 5', 'description': 'Sequence 5, Periods 1 - 5: (2 mg Alp, Placebo, 400 mg Las, then 200 mg Las)\n\nAll participants received:\n\nPeriod 1: 2 mg Alp Period 2: Placebo Period 3: 400 mg Las Period 4: 200 mg Las Period 5: 100 mg Las\n\nOrally with a 3 day washout between doses.'}, {'id': 'FG007', 'title': 'Sequence 6', 'description': 'Sequence 6, Periods 1 - 5 (400 mg Las, 200 mg Las, 2 mg Alp, 100 mg Las, then Placebo)\n\nAll participants received:\n\nPeriod 1: 400 mg Las Period 2: 200 mg Las Period 3: 2 mg Alp Period 4: 100 mg Las Period 5: Placebo\n\nOrally with a 3 day washout between doses.'}, {'id': 'FG008', 'title': 'Sequence 7', 'description': 'Sequence 7, Periods 1-5: (2 mg Alp, 400 mg Las, Placebo, 200 mg Las, then 100 mg Las)\n\nAll participants received:\n\nPeriod 1: 2 mg Alp Period 2: 400 mg Las Period 3: Placebo Period 4: 200 mg Las Period 5: 100 mg Las\n\nOrally with a 3 day washout between doses.'}, {'id': 'FG009', 'title': 'Sequence 8', 'description': 'Sequence 8, Periods 1 - 5: Placebo, 2 mg Lap, 100 mg Las, 400 mg Las, then 200 mg Las)\n\nAll participants received:\n\nPeriod 1: Placebo Period 2: 2 mg Las Period 3: 100 mg Las Period 4: 400 mg Las Period 5: 200 mg Las\n\nOrally with a 3 day washout between doses.'}, {'id': 'FG010', 'title': 'Sequence 9', 'description': 'Sequence 9, Periods 1 - 5: (100 mg Las, Placebo, 200 mg Las, 2 mg Alp, 400 mg Las)\n\nAll participants received:\n\nPeriod 1: 100 mg Las Period 2: Placebo Period 3: 200 mg Las Period 4: 2 mg Alp Period 5: 400 mg Las\n\nOrally with a 3 day washout between doses.'}, {'id': 'FG011', 'title': 'Sequence 10', 'description': 'Sequence 10, Periods 1 - 5: (200 mg Las, 100 mg Las, 400 mg Las, Placebo, then 2 mg Alp)\n\nAll participants received:\n\nPeriod 1: 200 mg Las Period 2: 100 mg Las Period 3: 400 mg Las Period 4: Placebo Period 5: 2 mg Alp\n\nOrally with a 3 day washout between doses.'}], 'periods': [{'title': 'Qualification Phase Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'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': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'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': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'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': '1'}, {'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'}]}], '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': 'Withdrawal by Subject', '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': 'Qualification Phase Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'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': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'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': '19'}, {'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': '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'}]}, {'type': 'Failure to meet randomization criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'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': 'Lost to Follow-up', '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'}]}, {'type': 'Protocol Violation', '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': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'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 Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants completed the Qualification Phase prior to entering the Treatment Phase.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants completed the Qualification Phase prior to entering the Treatment Phase.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Participants completed the Qualification Phase and crossed over to the Treatment Phase.', 'groupId': 'FG002', 'numSubjects': '6'}, {'comment': 'Participants completed the Qualification Phase and crossed over to the Treatment Phase.', 'groupId': 'FG003', 'numSubjects': '6'}, {'comment': 'Participants completed the Qualification Phase and crossed over to the Treatment Phase.', 'groupId': 'FG004', 'numSubjects': '5'}, {'comment': 'Participants completed the Qualification Phase and crossed over to the Treatment Phase.', 'groupId': 'FG005', 'numSubjects': '6'}, {'comment': 'Participants completed the Qualification Phase and crossed over to the Treatment Phase.', 'groupId': 'FG006', 'numSubjects': '6'}, {'comment': 'Participants completed the Qualification Phase and crossed over to the Treatment Phase.', 'groupId': 'FG007', 'numSubjects': '6'}, {'comment': 'Participants completed the Qualification Phase and crossed over to the Treatment Phase.', 'groupId': 'FG008', 'numSubjects': '6'}, {'comment': 'Participants completed the Qualification Phase and crossed over to the Treatment Phase.', 'groupId': 'FG009', 'numSubjects': '6'}, {'comment': 'Participants completed the Qualification Phase and crossed over to the Treatment Phase.', 'groupId': 'FG010', 'numSubjects': '5'}, {'comment': 'Participants completed the Qualification Phase and crossed over to the Treatment Phase.', 'groupId': 'FG011', 'numSubjects': '6'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}]}, {'title': 'Treatment Phase Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'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': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Treatment Phase Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'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': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Treatment Phase Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'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': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}], 'dropWithdraws': [{'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': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}]}, {'title': 'Treatment Phase Period 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'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': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Qualification Phase: Participants randomized in a 2-period crossover design with a washout period of at least 72 hours Treatment Phase: Participants randomized to 1 of 10 dosing sequences, irrespective of their qualification randomization, in a 5-period crossover design with a washout period of 3 days in between doses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Participants', 'description': 'All participants received one dose of alprazolam and placebo in the qualification phase and participants received at least one dose lasmiditan, alprazolam and/or placebo in the treatment phase.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '8.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '77', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '91', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-05', 'size': 618009, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-11-05T09:28', 'hasProtocol': True}, {'date': '2017-09-11', 'size': 469056, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-11-05T09:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-20', 'studyFirstSubmitDate': '2017-09-15', 'resultsFirstSubmitDate': '2019-11-08', 'studyFirstSubmitQcDate': '2017-09-15', 'lastUpdatePostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-20', 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores', 'timeFrame': 'Each Phase: 24 Hours', 'description': 'The Emax of Bipolar Drug Liking VAS Scores were derived as the maximum at-the-moment Drug Liking VAS score where the time to Emax was the corresponding time point at which the maximum score occurred. The bipolar Drug Liking VAS is consistent with FDA Guidance (January 2017) such that placebo should produce a score between 40 and 60 representing neutral drug-liking (ie, neither like nor dislike); a score ranging from 0 to 100 and a score of 0 indicates strong disliking, and a score of 100 indicates strong liking. Least squares mean (LS mean) was calculated using a linear mixed-effects model, including period, sequence, and treatment as fixed effects, and subject as a random effect, was used to evaluate the hypothesis tests of primary interest (at-the-moment Drug Liking) at the Emax.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose', 'description': 'Pharmacokinetics (PK) defined as the maximum observed drug concentration (Cmax) of lasmiditan'}, {'measure': 'PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞])', 'timeFrame': 'Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose', 'description': 'PK defined as the area under the curve of lasmiditan from zero to infinity (AUC\\[0-∞\\])'}, {'measure': 'PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS)', 'timeFrame': 'Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose', 'description': 'Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. Scales include: Overall drug liking (overall, my liking for this drug is) and ranges from 0 definitely not to 100 definitely so. Take Drug Again (I would take this drug again) and ranges from 0 definitely not to 100 definitely so. Good effects (I can feel good drug effects) and ranges from 0 definitely not to 100 definitely so. Bad effects (I can feel bad drug effects) and ranges from 0 definitely not to 100 definitely so. High (I am feeling) and ranges from 0 not at all high to 100 extremely high. Emax is derived as the maximum score across all postdose time points for each participant. Least Square (LS) Mean is calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.'}, {'measure': 'PD: Maximal Drug Effects (Emax) VAS (Hallucinations)', 'timeFrame': 'Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose', 'description': 'Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The hallucinations scale is presented meaning (I am hallucinating) and ranges from 0 not at all to 100 extremely. Emax is derived as the maximum score across all postdose time points for each participant. Median and interquartile range are reported for each treatment group.'}, {'measure': 'PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS)', 'timeFrame': 'Each Phase:Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose', 'description': 'Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The scales included: Alertness/Drowsiness (I am feeling) ranges from 0 very drowsy to 100 very alert. Agitation/Relaxation (my mood is) and ranges from 0 very relaxed to 100 very agitated. Emin is derived across all postdose time points for each participant. LS Mean was calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.'}, {'measure': 'PD: Mean Scores on Drug Similarity VAS Measures', 'timeFrame': 'Each Phase: 24 Hours Post Dose', 'description': 'Participants marked a point on a 100-mm horizontal line that best represented their response to the given question. The endpoints of each electronic scale were marked with descriptive anchors on a scale from 0 to 100 (Fraser et al. 1961; Bond and Lader 1974; Bigelow 1991; Shram et al. 2010). In the "How similar" questions, ranges from 0 to 100 and a score of 0 indicates definitely not similar, and a score of 100 indicates definitely similar.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recreational Drug Use', 'Prescription Drug Abuse (Not Dependent)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the abuse potential of study drug lasmiditan.\n\nLasmiditan will be compared to a marketed benzodiazepine, alprazolam (positive control), as well as to placebo (dummy substance that looks like lasmiditan or alprazolam without any active drug) to determine the potential for drug abuse. The dosages will be in tablet form and will be taken orally (by mouth).\n\nThis study will last about 55 days, including screening. Screening will occur within 28 days prior to qualification phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy males or females, as determined by medical history and physical examination.\n* Have a body mass index (BMI) of 18 to 32 kilograms per meter squared (kg/m²) inclusive, at the time of screening.\n* Must be recreational drug user and agree not to consume any recreational drugs during the study.\n\nExclusion Criteria:\n\n* Have known allergies to lasmiditan, alprazolam, related compounds, or any components of the formulation, or a history of significant atopy.\n* Are currently seeking or participating in treatment for addiction or substance-related disorders, or have recovered from substance abuse disorder.\n* Are currently taking excluded prescription or over-the-counter (OTC) medications.\n* Have a history of significant sleep disorder, including sleep apnea or narcolepsy.\n* Have a history of orthostatic hypotension, vertigo, syncope, or presyncope.\n* Have a history of brain injury, including a history of concussions.'}, 'identificationModule': {'nctId': 'NCT03286218', 'briefTitle': 'A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Subject- and Investigator-Blind, Placebo and Active-Controlled Study to Assess the Abuse Potential of Lasmiditan', 'orgStudyIdInfo': {'id': '16853'}, 'secondaryIdInfos': [{'id': 'H8H-MC-LAHB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo was administered orally in one of five treatment periods', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alprazolam 2 milligram (mg)', 'description': '2 mg of alprazolam was administered orally in one of five treatment periods', 'interventionNames': ['Drug: Alprazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Lasmiditan 100 mg', 'description': '100 mg of lasmiditan was administered orally in one of five treatment periods', 'interventionNames': ['Drug: Lasmiditan']}, {'type': 'EXPERIMENTAL', 'label': 'Lasmiditan 200 mg', 'description': '200 mg of lasmiditan was administered orally in one of five treatment periods', 'interventionNames': ['Drug: Lasmiditan']}, {'type': 'EXPERIMENTAL', 'label': 'Lasmiditan 400 mg', 'description': '400 mg of lasmiditan was administered orally in one of five treatment periods', 'interventionNames': ['Drug: Lasmiditan']}], 'interventions': [{'name': 'Lasmiditan', 'type': 'DRUG', 'otherNames': ['LY573144'], 'description': 'Administered orally', 'armGroupLabels': ['Lasmiditan 100 mg', 'Lasmiditan 200 mg', 'Lasmiditan 400 mg']}, {'name': 'Alprazolam', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Alprazolam 2 milligram (mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Vince & Associates Clinical Research, Inc.', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}