Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-29 @ 4:19 PM
Study NCT ID:
NCT04657666
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2020-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587251', 'term': 'nabiximols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@JazzPharma.com', 'phone': '215-832-3750', 'title': 'Clinical Trial Disclosure & Transparency', 'organization': 'Jazz Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).', 'description': 'A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.', 'eventGroups': [{'id': 'EG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 19, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 3, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Facial spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Lower Limb Muscle Tone-6 (LLMT-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7152', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Combined least mean square difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.23', 'pValueComment': 'Based on a combination of 300 linear mixed models for crossover data on the response variable change from baseline in LLMT-6 with period level LLMT-6 baseline covariate, treatment group, period, and sequence as fixed effects.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Pattern mixture model (PMM) control-based imputation, mixed model repeated measures (MMRM)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'description': 'LLMT-6 is defined as the average of the 6 individual Modified Ashworth Scale (MAS) transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body. Transformed MAS ranges from 0 (no increase in muscle tone) to 5 (affected part rigid in flexion or extension). The combined (treatment period 1 and treatment period 2) least square mean change from baseline in LLMT-6 score is being reported. Negative values indicate an improvement in muscle tone.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'LLMT-6 was assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lower Limb Muscle Tone-4 (LLMT-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'description': 'LLMT-4 is defined as the average of the 4 individual MAS transformed scores of knee flexors and knee extensors on both sides of the body. Transformed MAS ranges from 0 (no increase in muscle tone) to 5 (affected part rigid in flexion or extension). The combined (treatment period 1 and treatment period 2) least square mean change from baseline in LLMT-4 score is being reported. Negative values indicate an improvement in muscle tone.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'LLMT-4 was assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'description': 'A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety events were assessed in the Safety Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '10.48', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '10.85', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '9.06', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '8.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital signs were assessed in the Safety Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'spread': '8.12', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '9.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Electrocardiogram parameters were assessed in the Safety Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Physical exam parameters were assessed in the Safety Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Physical exam parameters were assessed in the Safety Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Laboratory Test Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'title': 'Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.144', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '-0.324', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.015', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '-0.316', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.010', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.011', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.172', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-0.013', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.009', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '40.58', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '35.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical laboratory tests were assessed in the Safety Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.101', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-0.017', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'unitOfMeasure': '10^12 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical laboratory tests were assessed in the Safety Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical laboratory tests were assessed in the Safety Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematocrit Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.006', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.001', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'description': 'Hematocrit was measured in whole blood samples. The ratio of packed cells to total volume was assessed. Normal ratio ranges from 0.350-0.470 female and 0.400-0.540 male (normal ranges per our central lab), 0.37 (or 37%) to 0.52 (or 52%) in adults. Lower hematocrit ratios indicate worse clinical outcome.', 'unitOfMeasure': 'ratio of packed cells to total volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical laboratory tests were assessed in the Safety Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocyte Mean Corpuscular Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.64', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '3.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'unitOfMeasure': 'fL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical laboratory tests were assessed in the Safety Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'unitOfMeasure': 'pg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical laboratory tests were assessed in the Safety Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Electrocardiogram Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'title': 'PR interval', 'categories': [{'measurements': [{'value': '11.4', 'spread': '102.54', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '24.79', 'groupId': 'OG001'}]}]}, {'title': 'QRS duration', 'categories': [{'measurements': [{'value': '0', 'spread': '13.61', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '9.34', 'groupId': 'OG001'}]}]}, {'title': 'QT interval', 'categories': [{'measurements': [{'value': '2.4', 'spread': '22.19', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '32.57', 'groupId': 'OG001'}]}]}, {'title': 'QTcB interval', 'categories': [{'measurements': [{'value': '1.1', 'spread': '56.32', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '51.80', 'groupId': 'OG001'}]}]}, {'title': 'QTcF interval', 'categories': [{'measurements': [{'value': '3.0', 'spread': '55.83', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '50.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Electrocardiogram parameters were assessed in the Safety Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Electrocardiogram Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.6', 'spread': '8.76', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '9.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital signs were assessed in the Safety Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'title': 'Baseline, Suicidal ideation, Wish to be dead', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Suicidal ideation, Non-specific active suicidal thoughts', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Suicidal ideation, Active with any methods (not planned) without intent to act', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Suicidal ideation, Active with some intent to act, without specific plan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Suicidal ideation, Active with specific plan and intent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Suicidal behavior, Preparatory acts or behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Suicidal behavior, Aborted attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Suicidal behavior, Interrupted attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Suicidal behavior, Actual attempt (non-fatal)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Suicidal behavior, Completed suicide', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Suicidal ideation or behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Self-injurious behavior without suicidal intent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, Suicidal ideation, Wish to be dead', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, Suicidal ideation, Non-specific active suicidal thoughts', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, Suicidal ideation, Active with any methods (not planned) without intent to act', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, Suicidal ideation, Active with some intent to act, without specific plan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, Suicidal ideation, Active with specific plan and intent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, Suicidal behavior, Preparatory acts or behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, Suicidal behavior, Aborted attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, Suicidal behavior, Interrupted attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, Suicidal behavior, Actual attempt (non-fatal)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, Suicidal behavior, Completed suicide', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, Suicidal ideation or behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, Self-injurious behavior without suicidal intent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21, Suicidal ideation, Wish to be dead', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21, Suicidal ideation, Non-specific active suicidal thoughts', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21, Suicidal ideation, Active with any methods (not planned) without intent to act', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21, Suicidal ideation, Active with some intent to act, without specific plan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21, Suicidal ideation, Active with specific plan and intent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21, Suicidal behavior, Preparatory acts or behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21, Suicidal behavior, Aborted attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21, Suicidal behavior, Interrupted attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21, Suicidal behavior, Actual attempt (non-fatal)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21, Suicidal behavior, Completed suicide', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21, Suicidal ideation or behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21, Self-injurious behavior without suicidal intent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Day 15, and Day 21', 'description': 'The C-SSRS is a short questionnaire that is used to assess suicidal ideation (5 questions) and behavior (5 questions) since last patient visit. The questionnaire is completed by participants answering yes or no to each question.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Suicidal ideation or behavior was assessed in the Safety Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations for Δ9-tetrahydrocannabinol (THC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'title': 'Day 1, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.60', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Day 1, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.77', 'groupId': 'OG000'}]}]}, {'title': 'Day 1, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.91', 'spread': '1.77', 'groupId': 'OG000'}]}]}, {'title': 'Day 15, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.13', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Day 15, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.07', 'spread': '1.96', 'groupId': 'OG000'}]}]}, {'title': 'Day 21, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Day 21, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.50', 'spread': '1.77', 'groupId': 'OG000'}]}]}, {'title': 'Day 21, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.08', 'spread': '2.90', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1: Day 1: predose,0-2 and 2-4 hours (hr) postdose. Day 15: 0-2 and 2-4 hr postdose. Day 21: predose,0-1 and 2-3 hr postdose.', 'description': 'Plasma concentrations were assessed using blood samples collected at the timepoints specified.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma concentrations were assessed in the Pharmacokinetic Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'title': '11-OH-THC: Day 1, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.31', 'spread': '1.87', 'groupId': 'OG000'}]}]}, {'title': '11-OH-THC: Day 1, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.17', 'spread': '1.52', 'groupId': 'OG000'}]}]}, {'title': '11-OH-THC: Day 1, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.79', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': '11-OH-THC: Day 15, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.12', 'spread': '1.92', 'groupId': 'OG000'}]}]}, {'title': '11-OH-THC: Day 15, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.91', 'spread': '2.23', 'groupId': 'OG000'}]}]}, {'title': '11-OH-THC: Day 21, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.77', 'spread': '1.42', 'groupId': 'OG000'}]}]}, {'title': '11-OH-THC: Day 21, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.22', 'spread': '1.66', 'groupId': 'OG000'}]}]}, {'title': '11-OH-THC: Day 21, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.75', 'spread': '3.10', 'groupId': 'OG000'}]}]}, {'title': '11-COOH-THC: Day 1, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.54', 'spread': '32.94', 'groupId': 'OG000'}]}]}, {'title': '11-COOH-THC: Day 1, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.53', 'spread': '24.16', 'groupId': 'OG000'}]}]}, {'title': '11-COOH-THC: Day 1, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.49', 'spread': '9.91', 'groupId': 'OG000'}]}]}, {'title': '11-COOH-THC: Day 15, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.75', 'spread': '47.02', 'groupId': 'OG000'}]}]}, {'title': '11-COOH-THC: Day 15, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.86', 'spread': '45.23', 'groupId': 'OG000'}]}]}, {'title': '11-COOH-THC: Day 21, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.59', 'spread': '74.28', 'groupId': 'OG000'}]}]}, {'title': '11-COOH-THC: Day 21, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.53', 'spread': '68.49', 'groupId': 'OG000'}]}]}, {'title': '11-COOH-THC: Day 21, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.31', 'spread': '59.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1: Day 1: predose,0-2 and 2-4 hours (hr) postdose. Day 15: 0-2 and 2-4 hr postdose. Day 21: predose,0-1 and 2-3 hr postdose.', 'description': 'Plasma concentrations were assessed using blood samples collected at the timepoints specified.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma concentrations were assessed in the Pharmacokinetic Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations for Cannabidiol (CBD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'title': 'Day 1, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'Day 1, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.55', 'groupId': 'OG000'}]}]}, {'title': 'Day 1, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Day 15, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Day 15, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.68', 'spread': '1.29', 'groupId': 'OG000'}]}]}, {'title': 'Day 21, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.80', 'groupId': 'OG000'}]}]}, {'title': 'Day 21, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.40', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Day 21, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.42', 'spread': '2.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1: Day 1: predose,0-2 and 2-4 hours (hr) postdose. Day 15: 0-2 and 2-4 hr postdose. Day 21: predose,0-1 and 2-3 hr postdose.', 'description': 'Plasma concentrations were assessed using blood samples collected at the timepoints specified.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma concentrations were assessed in the Pharmacokinetic Analysis Set in participants with available data.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nabiximols', 'description': 'A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).'}], 'classes': [{'title': '7-OH-CBD: Day 1, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.07', 'groupId': 'OG000'}]}]}, {'title': '7-OH-CBD: Day 1, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': '7-OH-CBD: Day 1, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.24', 'groupId': 'OG000'}]}]}, {'title': '7-OH-CBD: Day 15, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.14', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': '7-OH-CBD: Day 15, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.76', 'groupId': 'OG000'}]}]}, {'title': '7-OH-CBD: Day 21, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '0.80', 'groupId': 'OG000'}]}]}, {'title': '7-OH-CBD: Day 21, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.22', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': '7-OH-CBD: Day 21, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.59', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': '7-COOH-CBD: Day 1, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.06', 'spread': '4.91', 'groupId': 'OG000'}]}]}, {'title': '7-COOH-CBD: Day 1, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.67', 'spread': '47.41', 'groupId': 'OG000'}]}]}, {'title': '7-COOH-CBD: Day 1, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.49', 'spread': '3.50', 'groupId': 'OG000'}]}]}, {'title': '7-COOH-CBD: Day 15, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.84', 'spread': '47.81', 'groupId': 'OG000'}]}]}, {'title': '7-COOH-CBD: Day 15, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.78', 'spread': '46.27', 'groupId': 'OG000'}]}]}, {'title': '7-COOH-CBD: Day 21, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.95', 'spread': '69.64', 'groupId': 'OG000'}]}]}, {'title': '7-COOH-CBD: Day 21, 0-2H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.04', 'spread': '62.73', 'groupId': 'OG000'}]}]}, {'title': '7-COOH-CBD: Day 21, 2-4H postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.32', 'spread': '62.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1: Day 1: predose,0-2 and 2-4 hours (hr) postdose. Day 15: 0-2 and 2-4 hr postdose. Day 21: predose,0-1 and 2-3 hr postdose.', 'description': 'Plasma concentrations were assessed using blood sample collected at the timepoints specified.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma concentrations were assessed in the Pharmacokinetic Analysis Set in participants with available data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nabiximols First, Then Placebo', 'description': 'Participants who were randomized to receive GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received matching placebo treatment for 21 days (starting at Day 31; Treatment Period 2).'}, {'id': 'FG001', 'title': 'Placebo First, Then Nabiximols', 'description': 'Participants who were randomized to receive matching placebo self-administered for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received GW-1000-02 (nabiximols) self-administered as an oromucosal spray in the morning and evening for 21 days (starting on Day 31; Treatment Period 2).'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal of participant consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawn/discontinued due to AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Administrative decision by investigator, GW, or a regulatory authority', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawn/discontinued due to AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'A total of 68 participants who met all inclusion and no exclusion criteria were randomized to treatment at 9 clinic centers in Poland and 1 center in Czech Republic.', 'preAssignmentDetails': 'Randomized participants completed 2 treatment periods with administration of study drug for 21 days per period. A washout period of at least 7 days separated the 2 treatment periods. During the washout period, participants continued their current MS anti-spasticity medications. Each treatment period included a dose titration phase (\\~14 days) followed by a maintenance-dose phase (\\~7 days), where the optimized dose level remained unchanged for the remainder of the period after titration.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nabiximols First, Then Placebo', 'description': 'Participants who were randomized to receive GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received matching placebo treatment for 21 days (starting at Day 31; Treatment Period 2).'}, {'id': 'BG001', 'title': 'Placebo First, Then Nabiximols', 'description': 'Participants who were randomized to receive matching placebo self-administered for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received GW-1000-02 (nabiximols) self-administered as an oromucosal spray in the morning and evening for 21 days (starting on Day 31; Treatment Period 2).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.7', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '49.7', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '49.7', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Czechia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline demographics were assessed in the Full Analysis Set.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-02', 'size': 748310, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-26T10:57', 'hasProtocol': True}, {'date': '2022-06-06', 'size': 1266693, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-26T10:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-14', 'studyFirstSubmitDate': '2020-11-11', 'resultsFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-14', 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Lower Limb Muscle Tone-6 (LLMT-6)', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'description': 'LLMT-6 is defined as the average of the 6 individual Modified Ashworth Scale (MAS) transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body. Transformed MAS ranges from 0 (no increase in muscle tone) to 5 (affected part rigid in flexion or extension). The combined (treatment period 1 and treatment period 2) least square mean change from baseline in LLMT-6 score is being reported. Negative values indicate an improvement in muscle tone.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Lower Limb Muscle Tone-4 (LLMT-4)', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'description': 'LLMT-4 is defined as the average of the 4 individual MAS transformed scores of knee flexors and knee extensors on both sides of the body. Transformed MAS ranges from 0 (no increase in muscle tone) to 5 (affected part rigid in flexion or extension). The combined (treatment period 1 and treatment period 2) least square mean change from baseline in LLMT-4 score is being reported. Negative values indicate an improvement in muscle tone.'}, {'measure': 'Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'description': 'A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.'}, {'measure': 'Change From Baseline in Blood Pressure', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)'}, {'measure': 'Change From Baseline in Heart Rate', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)'}, {'measure': 'Change From Baseline in Weight', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)'}, {'measure': 'Change From Baseline in Body Mass Index', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)'}, {'measure': 'Change From Baseline in Clinical Laboratory Test Values', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)'}, {'measure': 'Change From Baseline in Erythrocytes', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)'}, {'measure': 'Change From Baseline in Hemoglobin', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)'}, {'measure': 'Change From Baseline in Hematocrit Ratio', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)', 'description': 'Hematocrit was measured in whole blood samples. The ratio of packed cells to total volume was assessed. Normal ratio ranges from 0.350-0.470 female and 0.400-0.540 male (normal ranges per our central lab), 0.37 (or 37%) to 0.52 (or 52%) in adults. Lower hematocrit ratios indicate worse clinical outcome.'}, {'measure': 'Change From Baseline in Erythrocyte Mean Corpuscular Volume', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)'}, {'measure': 'Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)'}, {'measure': 'Change From Baseline in Electrocardiogram Parameters', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)'}, {'measure': 'Change From Baseline in Electrocardiogram Pulse Rate', 'timeFrame': 'Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)'}, {'measure': 'Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)', 'timeFrame': 'Baseline, Day 15, and Day 21', 'description': 'The C-SSRS is a short questionnaire that is used to assess suicidal ideation (5 questions) and behavior (5 questions) since last patient visit. The questionnaire is completed by participants answering yes or no to each question.'}, {'measure': 'Plasma Concentrations for Δ9-tetrahydrocannabinol (THC)', 'timeFrame': 'Period 1: Day 1: predose,0-2 and 2-4 hours (hr) postdose. Day 15: 0-2 and 2-4 hr postdose. Day 21: predose,0-1 and 2-3 hr postdose.', 'description': 'Plasma concentrations were assessed using blood samples collected at the timepoints specified.'}, {'measure': 'Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)', 'timeFrame': 'Period 1: Day 1: predose,0-2 and 2-4 hours (hr) postdose. Day 15: 0-2 and 2-4 hr postdose. Day 21: predose,0-1 and 2-3 hr postdose.', 'description': 'Plasma concentrations were assessed using blood samples collected at the timepoints specified.'}, {'measure': 'Plasma Concentrations for Cannabidiol (CBD)', 'timeFrame': 'Period 1: Day 1: predose,0-2 and 2-4 hours (hr) postdose. Day 15: 0-2 and 2-4 hr postdose. Day 21: predose,0-1 and 2-3 hr postdose.', 'description': 'Plasma concentrations were assessed using blood samples collected at the timepoints specified.'}, {'measure': 'Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)', 'timeFrame': 'Period 1: Day 1: predose,0-2 and 2-4 hours (hr) postdose. Day 15: 0-2 and 2-4 hr postdose. Day 21: predose,0-1 and 2-3 hr postdose.', 'description': 'Plasma concentrations were assessed using blood sample collected at the timepoints specified.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spasticity', 'multiple sclerosis', 'nabiximols', 'adjunctive therapy', 'velocity-dependent muscle tone'], 'conditions': ['Spasticity in Participants With Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '39106541', 'type': 'DERIVED', 'citation': 'Bethoux FA, Farrell R, Checketts D, Sahr N, Berwaerts J, Alexander JK, Skobieranda F. A randomized, double-blind, placebo-controlled trial to evaluate the effect of nabiximols oromucosal spray on clinical measures of spasticity in patients with multiple sclerosis. Mult Scler Relat Disord. 2024 Sep;89:105740. doi: 10.1016/j.msard.2024.105740. Epub 2024 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate the effect of multiple doses of nabiximols as adjunctive therapy compared with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Modified Ashworth Scale Lower Limb Muscle Tone-6 \\[MAS LLMT-6\\]) in participants with multiple sclerosis (MS) who have not achieved adequate relief from spasticity with other antispasticity medications.', 'detailedDescription': 'Each period of this multicenter, randomized, double-blind, placebo-controlled, 2-treatment, 2-period, crossover trial includes a 7-day Baseline period, a 3-week treatment period (comprising a 2-week titration phase and a 1-week maintenance phase).\n\nEligible participants will enter the 7-day baseline period of each treatment period. During baseline, participants will maintain their optimized oral MS antispasticity medication regimen and record their 11-point NRS spasticity score and spasm count using an electronic daily diary. On Day 1, eligible participants will be randomized to 1 of 2 treatment sequences, each composed of 2 treatment periods, with administration of multiple doses of nabiximols or placebo in a 1:1 ratio.\n\nParticipants will be advised to titrate the investigational medicinal product (IMP), beginning with 1 spray/day, to an optimized dose or to a maximum of 12 sprays/day over the first 14 days of treatment. Participants should continue at the same dose level achieved at the end of the titration phase ±1 spray divided into a morning dose and an evening dose for the remainder of the treatment period.\n\nLower limb muscle tone, health-related quality of life, safety, tolerability, and pharmacokinetics will be evaluated during the treatment period.\n\nParticipants who complete the trial will participate for a maximum of 90 days, which consists of a maximum 29-day screening period and a maximum 61-day treatment period (s), including washout between periods, and safety follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nScreening (Visit 1)\n\n* Has had a diagnosis with any disease subtype of multiple sclerosis (MS), by revised 2017 McDonald criteria, for at least 12 months prior to Visit 1 and is expected to remain stable for the duration of the trial\n* Has a Modified Ashworth Scale (MAS) untransformed score of at least 2 in 2 or more of 6 muscle groups (right knee flexors, left knee flexors, right knee extensors, left knee extensors, right plantar flexors, or left plantar flexors) at Visit 1\n* Currently receiving optimized treatment with at least 1 oral antispasticity drug (baclofen, tizanidine, and/or dantrolene) that has been stable for at least 30 days prior to Visit 1. Despite optimization, the participant does not have adequate relief of spasticity symptoms, including muscle spasms. Optimization of antispasticity medications is defined as having reached the most efficacious and best tolerated dose according to the relevant local prescribing information. The participant must be willing to maintain the same antispasticity medication and not plan to initiate a new course of physiotherapy for the duration of the trial.\n* If currently receiving an approved MS disease-modifying therapy, it must be at a stable dose for at least 3 months prior to Visit 1 and is expected to remain stable for the duration of the trial.\n* If currently receiving dalfampridine or fampridine, it must be at a stable dose for at least 3 months prior to Visit 1 and is expected to remain stable for the duration of the trial.\n* For Randomization (Visit 2): Completed at least 5 of 7 days of their electronic diary reporting during the 7 days immediately preceding Visit 2 (Day 1)\n\nExclusion Criteria:\n\n* Has taken nabiximols, cannabis, or a cannabis-derived product for medicinal or recreational purposes in the 30 days prior to Visit 1 and unable to abstain for the duration of the study\n* Did not tolerate or did not respond adequately to treatment with nabiximols or another cannabis-based medication if exposed at any time before the 30-day period prior to Visit 1\n* Any concomitant disease or disorder that has spasticity-like symptoms or that may influence the participant's level of spasticity\n* Medical history suggests that relapse/remission is likely to occur during the trial, which, in the opinion of the investigator, is expected to influence the participant's spasticity\n* Has had a relapse of MS within the 60 days prior to Visit 1\n* Currently using botulinum toxin injection for the relief of spasticity (within 6 months of Visit 1) and is unwilling to abstain for the duration of the trial\n* Currently taking antipsychotic medication\n* Currently taking benzodiazepines unless doses and dosing regimen have been stable for at least 30 days prior to Visit 1\n* Clinically suspected to have a contracture in one of the muscle groups of the lower limbs, preventing assessment with the MAS\n* Has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal product (IMP)\n* Male and fertile (i.e., after puberty unless permanently sterile by bilateral orchiectomy) unless willing to ensure that he uses male contraception (condom or vasectomy) or remains sexually abstinent during the trial and for 3 months thereafter\n* Female and of childbearing potential (i.e., following menarche and until becoming postmenopausal for ≥ 12 consecutive months unless permanently sterile by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) unless willing to ensure that she uses a highly effective method of birth control (e.g., intrauterine device/hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence) during the trial and for 3 months thereafter. Participants using combined hormonal methods or a progestogen-only pill or injection or implant should use an additional barrier method such as a male condom or diaphragm during the trial and for 3 months thereafter.\n* Female and pregnant (positive pregnancy test at Visit 1 or Visit 2), lactating, or planning pregnancy during the course of the trial or within 3 months thereafter\n* Has received an IMP within the 30 days prior to Visit 1\n* Has any history of suicidal behavior in the 5 years prior to Visit 1 or a score of 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the month prior to Visit 1\n* Has donated blood during the 3 months prior to Visit 1 and is unwilling to abstain from donation of blood during the trial\n* Has been previously randomized into this trial\n* Has any known or suspected history of alcohol or substance abuse (including opiate abuse) or dependence within 1 year prior to Visit 1\n* Currently using an illicit drug or current nonprescribed use of any prescription drug\n* Has a history of psychiatric or neurologic disorder that, in the opinion of the investigator, may interfere with trial participation, data interpretation, or conduct of trial procedures\n* Has a history of severe psychiatric disorder that may be exacerbated by the use of a cannabinoid-containing product.\n* Has any planned clinical interventions or intends to change any or all medications that may have an effect on spasticity or MS during the trial"}, 'identificationModule': {'nctId': 'NCT04657666', 'acronym': 'RELEASE MSS1', 'briefTitle': 'Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jazz Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'GWSP19066'}, 'secondaryIdInfos': [{'id': '2019-002625-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nabiximols', 'description': 'Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides. Each spray delivers 100 microliters (μL) of nabiximols.\n\nNabiximols will be self-administered by participants as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.', 'interventionNames': ['Drug: Nabiximols']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo to match nabiximols will be presented as an oromucosal spray containing the excipients ethanol and propylene glycol (50% v/v) with colorings and flavored with peppermint oil (0.05% v/v). Each spray will deliver 100 μL containing no active ingredients.\n\nPlacebo will be self-administered by participants as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nabiximols', 'type': 'DRUG', 'otherNames': ['GW-1000-02', 'Sativex'], 'description': 'oromucosal spray', 'armGroupLabels': ['Nabiximols']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oromucosal spray', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '565 01', 'city': 'Choceň', 'country': 'Czechia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 50.00161, 'lon': 16.22303}}, {'zip': '61-853', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'country': 'Poland', 'facility': 'Clinical Trial Site 2', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '62-064', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'country': 'Poland', 'facility': 'Clinical Trial Site 1', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '85-163', 'city': 'Bydgoszcz', 'state': 'Kuyavian-Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '30-539', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Clinical Trial Site 1', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '32-600', 'city': 'Oświęcim', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 50.03437, 'lon': 19.21037}}, {'zip': '01-211', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Clinical Trial Site 2', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '01-868', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Clinical Trial Site 1', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '80-803', 'city': 'Gdansk', 'state': 'Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '41-500', 'city': 'Chorzów', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 50.30582, 'lon': 18.9742}}, {'zip': '40-123', 'city': 'Katowice', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Clinical Trial Site 3', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '40-571', 'city': 'Katowice', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Clinical Trial Site 1', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '40-684', 'city': 'Katowice', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Clinical Trial Site 2', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '30-149', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '41-800', 'city': 'Zabrze', 'country': 'Poland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'zip': '25-726', 'city': 'Kielce', 'state': 'Świętokrzyskie Voivodeship', 'country': 'Poland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 50.87033, 'lon': 20.62752}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}