Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-29 @ 11:23 PM
Study NCT ID:
NCT03053427
Status:
COMPLETED
Last Update Posted:
2024-12-12
First Post:
2017-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012148', 'term': 'Restless Legs Syndrome'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C493250', 'term': '1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astellas.resultsdisclosure@astellas.com', 'phone': '+81 3-3244-0512', 'title': 'Clinical Trial Disclosure', 'organization': 'Astellas Pharma Inc.'}, 'certainAgreement': {'otherDetails': "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to week 13', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily after the evening meal.', 'otherNumAtRisk': 186, 'deathsNumAtRisk': 186, 'otherNumAffected': 32, 'seriousNumAtRisk': 186, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Gabapentin Enacarbil', 'description': 'Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \\< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.', 'otherNumAtRisk': 189, 'deathsNumAtRisk': 189, 'otherNumAffected': 59, 'seriousNumAtRisk': 189, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Somnolence neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 26, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily after the evening meal.'}, {'id': 'OG001', 'title': 'Gabapentin Enacarbil', 'description': 'Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \\< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.5', 'groupId': 'OG000', 'lowerLimit': '-11.4', 'upperLimit': '-9.5'}, {'value': '-11.7', 'groupId': 'OG001', 'lowerLimit': '-12.6', 'upperLimit': '-10.7'}]}]}], 'analyses': [{'pValue': '0.088', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7', 'groupDescription': 'MMRM with compound symmetry as the covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point.', 'statisticalMethod': 'Mixed Model of Repeated Measurements', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 12', 'description': 'The IRLS consisted of 10-item scale for assessing severity of restless legs syndrome (RLS) with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 to 40. Higher IRLS score indicated greater disease activity. Mixed Model of Repeated Measurements (MMRM) model with compound symmetry as a covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all participants who received the study drug for the treatment period and were evaluated for at least one efficacy (either primary or secondary) endpoint during the treatment period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IRLS Score at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily after the evening meal.'}, {'id': 'OG001', 'title': 'Gabapentin Enacarbil', 'description': 'Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \\< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '-2.3'}, {'value': '-4.2', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '-3.4'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'groupId': 'OG000', 'lowerLimit': '-5.2', 'upperLimit': '-3.4'}, {'value': '-5.8', 'groupId': 'OG001', 'lowerLimit': '-6.7', 'upperLimit': '-4.9'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'groupId': 'OG000', 'lowerLimit': '-6.9', 'upperLimit': '-5.0'}, {'value': '-7.5', 'groupId': 'OG001', 'lowerLimit': '-8.4', 'upperLimit': '-6.5'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.4', 'groupId': 'OG000', 'lowerLimit': '-8.4', 'upperLimit': '-6.3'}, {'value': '-8.8', 'groupId': 'OG001', 'lowerLimit': '-9.9', 'upperLimit': '-7.8'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'groupId': 'OG000', 'lowerLimit': '-9.8', 'upperLimit': '-7.8'}, {'value': '-9.8', 'groupId': 'OG001', 'lowerLimit': '-10.8', 'upperLimit': '-8.8'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.6', 'groupId': 'OG000', 'lowerLimit': '-10.6', 'upperLimit': '-8.5'}, {'value': '-11.2', 'groupId': 'OG001', 'lowerLimit': '-12.3', 'upperLimit': '-10.2'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.5', 'groupId': 'OG000', 'lowerLimit': '-11.6', 'upperLimit': '-9.4'}, {'value': '-11.9', 'groupId': 'OG001', 'lowerLimit': '-13.0', 'upperLimit': '-10.8'}]}]}, {'title': 'EoT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.2', 'groupId': 'OG000', 'lowerLimit': '-11.4', 'upperLimit': '-9.1'}, {'value': '-11.1', 'groupId': 'OG001', 'lowerLimit': '-12.2', 'upperLimit': '-9.9'}]}]}], 'analyses': [{'pValue': '0.051', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'groupDescription': 'LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Time frame: week 1'}, {'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7', 'groupDescription': 'LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Time frame: week 2'}, {'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7', 'groupDescription': 'LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Time frame: week 4'}, {'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '-0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7', 'groupDescription': 'LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Time frame: week 6'}, {'pValue': '0.184', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7', 'groupDescription': 'LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Time frame: week 8'}, {'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7', 'groupDescription': 'LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Time frame: week 10'}, {'pValue': '0.087', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8', 'groupDescription': 'LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Time frame: week 12'}, {'pValue': '0.312', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8', 'groupDescription': 'LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Time frame: EoT'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and weeks 1, 2, 4, 6, 8, 10, 12 and EoT (week 12)', 'description': 'ANCOVA model with the baseline value as a covariate was used.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an Investigator-rated Clinical Global Impression (ICGI) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily after the evening meal.'}, {'id': 'OG001', 'title': 'Gabapentin Enacarbil', 'description': 'Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \\< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000', 'lowerLimit': '45.8', 'upperLimit': '60.6'}, {'value': '57.4', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '64.6'}]}]}], 'analyses': [{'pValue': '0.467', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '-6.4', 'ciUpperLimit': '14.8', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'EoT (week 12)', 'description': 'ICGI was assessed by 7-point ordinate scale. Participants who were "Very much improved" or "Much improved" were defined as responders.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Patient-rated Clinical Global Impression (PCGI) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily after the evening meal.'}, {'id': 'OG001', 'title': 'Gabapentin Enacarbil', 'description': 'Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \\< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000', 'lowerLimit': '43.1', 'upperLimit': '57.9'}, {'value': '56.4', 'groupId': 'OG001', 'lowerLimit': '49.0', 'upperLimit': '63.6'}]}]}], 'analyses': [{'pValue': '0.300', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '16.5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'EoT (week 12)', 'description': 'PCGI was assessed by 7-point ordinate scale. Participants who were "Very much improved" or "Much improved" were defined as responders.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pittsburgh Sleep Quality Index Total Score (PSQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily after the evening meal.'}, {'id': 'OG001', 'title': 'Gabapentin Enacarbil', 'description': 'Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \\< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-2.1', 'upperLimit': '-1.4'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '-1.4'}]}]}], 'analyses': [{'pValue': '0.877', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'groupDescription': 'LMS difference (gabapentin enacarbil group minus placebo group) of the changes in PSQI component and global scores from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and EoT (week 12)', 'description': 'The self-rated items of the PSQI generate seven component scores (range of subscale scores, 0-3). The sum of these seven component scores yielded one global score of subjective sleep quality (range, 0-21). Higher scores represent poorer subjective sleep. ANCOVA model with the baseline value as a covariate was used.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Athens Insomnia Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily after the evening meal.'}, {'id': 'OG001', 'title': 'Gabapentin Enacarbil', 'description': 'Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \\< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '-2.0'}, {'value': '-2.5', 'groupId': 'OG001', 'lowerLimit': '-2.9', 'upperLimit': '-2.0'}]}]}], 'analyses': [{'pValue': '0.975', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'groupDescription': 'LSM difference (gabapentin enacarbil group minus placebo group) of the changes in total score of Athens insomnia scale from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and EoT (week 12)', 'description': 'Athens Insomnia Scale consisted of 8-item scale (range of subscale scores, 0-3). The scale range of Athens Insomnia was 0-24. Higher scores represent poorer sleep quality. ANCOVA model with the baseline value as a covariate was used.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Restless Legs Syndrome (RLS) Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily after the evening meal.'}, {'id': 'OG001', 'title': 'Gabapentin Enacarbil', 'description': 'Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \\< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '-0.7'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '-0.7'}]}]}], 'analyses': [{'pValue': '0.838', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'groupDescription': 'LSM difference (gabapentin enacarbil group minus placebo group) of the changes in RLS pain score from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and EoT (week 12)', 'description': 'The scale range of RLS pain score was 0-10. Higher scores represent greater RLS pain intensity. ANCOVA model with the baseline value as a covariate was used.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Status Score of EuroQol-5 Dimension-5 Level (EQ-5D-5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily after the evening meal.'}, {'id': 'OG001', 'title': 'Gabapentin Enacarbil', 'description': 'Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \\< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '15.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and EoT (week 12)', 'description': 'Health status was assessed by general visual analog scale (VAS). The VAS ranges from 0 (worst health status) and 100 (best health status).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily after the evening meal.'}, {'id': 'OG001', 'title': 'Gabapentin Enacarbil', 'description': 'Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \\< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related TEAEs', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs leading to discontinuation of study drug', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related TEAEs leading to disc. of study drug', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to week 13', 'description': 'Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) with onset after the start of the run-in period. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. Serious TEAE was an AE considered serious.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAF) consisted of all participants given at least one dose of the study drug for the treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily after the evening meal.'}, {'id': 'FG001', 'title': 'Gabapentin Enacarbil', 'description': 'Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \\< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '189'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Worsening of the target disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants with moderate to severe idiopathic restless legs syndrome were enrolled in 51 study sites in Japan.', 'preAssignmentDetails': 'Participants received single-blind placebo for 1 week (run-in period). Subsequently, eligible participants were randomized to receive gabapentin enacarbil or placebo orally once daily after dinner for 12 weeks (treatment period).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily after the evening meal.'}, {'id': 'BG001', 'title': 'Gabapentin Enacarbil', 'description': 'Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \\< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week (upward titration period) followed by gabapentin enacarbil 600 mg for 11 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52.2', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '51.1', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '51.6', 'spread': '13.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '375', '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': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '375', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'International Restless Legs Syndrome Rating Scale (IRLS) score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '374', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23.8', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '23.7', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '23.7', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The IRLS consisted of 10-item scale for assessing severity of restless legs syndrome with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 to 40. Higher IRLS score indicated greater disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data were provided for the full analysis set (FAS), which included all participants who received study drug and were evaluated for at least one efficacy (either primary or secondary) endpoint during the treatment period.'}], 'populationDescription': 'Safety Analysis Set (SAF) consisted of all participants given at least one dose of the study drug for the treatment period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-13', 'size': 918117, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-13T16:57', 'hasProtocol': True}, {'date': '2018-09-03', 'size': 338430, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-13T17:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 375}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2017-02-12', 'resultsFirstSubmitDate': '2019-06-18', 'studyFirstSubmitQcDate': '2017-02-12', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-18', 'studyFirstPostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12', 'timeFrame': 'Baseline and week 12', 'description': 'The IRLS consisted of 10-item scale for assessing severity of restless legs syndrome (RLS) with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 to 40. Higher IRLS score indicated greater disease activity. Mixed Model of Repeated Measurements (MMRM) model with compound symmetry as a covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in IRLS Score at Each Time Point', 'timeFrame': 'Baseline and weeks 1, 2, 4, 6, 8, 10, 12 and EoT (week 12)', 'description': 'ANCOVA model with the baseline value as a covariate was used.'}, {'measure': 'Percentage of Participants With an Investigator-rated Clinical Global Impression (ICGI) Response', 'timeFrame': 'EoT (week 12)', 'description': 'ICGI was assessed by 7-point ordinate scale. Participants who were "Very much improved" or "Much improved" were defined as responders.'}, {'measure': 'Percentage of Participants With a Patient-rated Clinical Global Impression (PCGI) Response', 'timeFrame': 'EoT (week 12)', 'description': 'PCGI was assessed by 7-point ordinate scale. Participants who were "Very much improved" or "Much improved" were defined as responders.'}, {'measure': 'Change From Baseline in Pittsburgh Sleep Quality Index Total Score (PSQI)', 'timeFrame': 'Baseline and EoT (week 12)', 'description': 'The self-rated items of the PSQI generate seven component scores (range of subscale scores, 0-3). The sum of these seven component scores yielded one global score of subjective sleep quality (range, 0-21). Higher scores represent poorer subjective sleep. ANCOVA model with the baseline value as a covariate was used.'}, {'measure': 'Change From Baseline in Athens Insomnia Scale', 'timeFrame': 'Baseline and EoT (week 12)', 'description': 'Athens Insomnia Scale consisted of 8-item scale (range of subscale scores, 0-3). The scale range of Athens Insomnia was 0-24. Higher scores represent poorer sleep quality. ANCOVA model with the baseline value as a covariate was used.'}, {'measure': 'Change From Baseline in Restless Legs Syndrome (RLS) Pain Score', 'timeFrame': 'Baseline and EoT (week 12)', 'description': 'The scale range of RLS pain score was 0-10. Higher scores represent greater RLS pain intensity. ANCOVA model with the baseline value as a covariate was used.'}, {'measure': 'Change From Baseline in Health Status Score of EuroQol-5 Dimension-5 Level (EQ-5D-5L)', 'timeFrame': 'Baseline and EoT (week 12)', 'description': 'Health status was assessed by general visual analog scale (VAS). The VAS ranges from 0 (worst health status) and 100 (best health status).'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From first dose of study drug up to week 13', 'description': 'Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) with onset after the start of the run-in period. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. Serious TEAE was an AE considered serious.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Restless Legs Syndrome', 'ASP8825', 'Gabapentin enacarbil'], 'conditions': ['Restless Legs Syndrome (RLS)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=333', 'label': 'Link to results on the Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in participants with moderate-to-severe idiopathic restless legs syndrome. This study also assessed the safety of Gabapentin enacarbil.', 'detailedDescription': 'After 1 week run in period with single-blind placebo, participants meeting the inclusion and none of the exclusion criteria were randomized to receive double-blind treatment with either gabapentin enacarbil 600 mg or placebo for 12 weeks treatment period. After then, single-blind placebo was given for 1 week for follow-up observation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has Restless Legs Syndrome (RLS), based on the International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic Criteria.\n* Subject has reported history of RLS symptoms for at least 15 days in the month prior to the first dosing; if on treatment, this frequency of symptoms was started before treatment.\n* Subject with International Restless Legs Syndrome Rating Scale (IRLS) score ≥ 15.\n* Subject has discontinued dopamine agonists, and/or gabapentin at least 1 week prior to the first dosing.\n* Subject has discontinued other treatments for RLS at least 2 weeks prior to the first dosing.\n* Female subject must either:\n\nBe of non-childbearing potential:\n\n* Post-menopausal (defined as at least 1 year without any menses) prior to Screening, or\n* documented surgically sterile\n\nOr, if of childbearing potential:\n\n* Agree not to try to become pregnant during the study and for 28 days after the final study drug administration\n* And have a negative urine pregnancy test at Screening\n* And, if heterosexually active, agree to consistently use two forms of highly effective birth control starting at Screening and throughout the study period and for 28 days after the final study drug administration.\n\n * Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 28 days after the final study drug administration.\n * Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.\n * Subject agrees not to participate in another interventional study while on treatment.\n * Subject with a Body Mass Index of ≥ 18.5 and \\< 30.\n * Subject with estimated creatinine clearance of ≥ 60 mL/min.\n\nExclusion Criteria:\n\n* Subject has a sleep disorder that may significantly affect the assessment of RLS.\n* Subject has a history of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment.\n* Subject has neurologic disease or movement disorder.\n* Subject has poorly controlled diabetes, iron deficiency anemia, or are currently taking any sedative/hypnotic.\n* Subject has a history of suicide attempt within 6 months prior to informed consent.\n* Subject has a high level of Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST).\n* Subject is currently suffering from moderate or severe depression.\n* Subject has a history of alcohol dependence or drug abuse, or subject had alcohol or drug abuse or dependence in the last 1 year.\n* Subject is a shift worker, professional driver, or operator of dangerous machinery.\n* Subject has clinically significant or unstable medical conditions.\n* Subject has a history of hypersensitivity reaction to gabapentin.\n* Subject has previously taken pregabalin, gabapentin enacarbil, or the study drug of Gabapentin enacarbil.\n* Subject has participated in a clinical study for another investigational drug or medical device or post-marketing clinical study within 12 weeks (84 days) prior to the first dosing, or is currently participating in any of these studies.'}, 'identificationModule': {'nctId': 'NCT03053427', 'briefTitle': 'A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Gabapentin Enacarbil Post-marketing Clinical Study A Randomized, Double-blind, Placebo-controlled, Parallel-group Study in Subjects With Restless Legs Syndrome.', 'orgStudyIdInfo': {'id': '8825-CL-0101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo was administered orally once daily after the evening meal.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Gabapentin enacarbil', 'description': 'Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \\< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week followed by gabapentin enacarbil 600 mg for 11 weeks.', 'interventionNames': ['Drug: Gabapentin enacarbil']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Placebo']}, {'name': 'Gabapentin enacarbil', 'type': 'DRUG', 'otherNames': ['Regnite'], 'description': 'Oral administration', 'armGroupLabels': ['Gabapentin enacarbil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Site JP00025', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Site JP00029', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Site JP00040', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Site JP00006', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Site JP00022', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Site JP00002', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Site JP00003', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Site JP00004', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Site JP00023', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Kawanishi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Site JP00041', 'geoPoint': {'lat': 34.81667, 'lon': 135.41667}}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Site JP00005', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Site JP00038', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Site JP00007', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Site JP00017', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Site JP00049', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Site JP00050', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokosuka', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Site JP00009', 'geoPoint': {'lat': 35.28361, 'lon': 139.66722}}, {'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Site JP00032', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'city': 'Tokorozawa', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Site JP00043', 'geoPoint': {'lat': 35.79916, 'lon': 139.46903}}, {'city': 'Arakawa City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Site JP00012', 'geoPoint': {'lat': 35.73825, 'lon': 139.78047}}, {'city': 'Chōfu', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Site JP00001', 'geoPoint': {'lat': 35.65924, 'lon': 139.54837}}, {'city': 'Chōfu', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Site JP00028', 'geoPoint': {'lat': 35.65924, 'lon': 139.54837}}, {'city': 'Chūō', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Site JP00018', 'geoPoint': {'lat': 35.67004, 'lon': 139.77544}}, {'city': 'Chūō', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Site JP00024', 'geoPoint': {'lat': 35.67004, 'lon': 139.77544}}, {'city': 'Meguro City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Site 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'Osaka', 'country': 'Japan', 'facility': 'Site JP00037', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site JP00039', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site JP00047', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Site JP00030', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Site JP00044', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}