Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-01-25 @ 12:42 AM
Study NCT ID:
NCT01668667
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2012-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000077206', 'term': 'Gabapentin'}, {'id': 'C493250', 'term': '1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '877-936-6778', 'title': 'XenoPort Call Center', 'organization': 'XenoPort, Inc.'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs are collected from the start of study medication and until the follow-up contact. SAEs are collected over the same time period as AEs. SAEs related to study participation are recorded from the time of consenting up to & including any follow-up contact', 'description': 'All safety summaries were based on Safety Population, which was defined as all subjects who received at least 1 dose or any portion of a dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'GSK1838262 600 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM', 'otherNumAtRisk': 122, 'otherNumAffected': 55, 'seriousNumAtRisk': 122, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'GSK1838262 450 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM', 'otherNumAtRisk': 123, 'otherNumAffected': 56, 'seriousNumAtRisk': 123, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'GSK1838262 300 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM', 'otherNumAtRisk': 121, 'otherNumAffected': 33, 'seriousNumAtRisk': 121, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'GSK1838262 Placebo Match', 'description': 'Once-daily dose with food in the evening at approximately 5 PMmatching placebo.', 'otherNumAtRisk': 121, 'otherNumAffected': 46, 'seriousNumAtRisk': 121, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Somnolence', 'notes': 'Treatment Emergent AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 121, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'notes': 'Treatment Emergent AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 121, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'notes': 'Treatment Emergent AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 121, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'notes': 'Treatment Emergent AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 121, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'notes': 'Treatment Emergent AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 121, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'notes': 'Treatment Emergent AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Ligament rupture', 'notes': 'Unrelated treatment emergent SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'notes': 'Unrelated treatment emergent SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alcohol withdrawal syndrome', 'notes': 'Unrelated treatment emergent SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'notes': 'Unrelated treatment emergent SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change From Baseline to the End of Treatment in the International Restless Legs Syndrome (IRLS) Rating Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1838262 600 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'OG001', 'title': 'GSK1838262 450 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'OG002', 'title': 'GSK1838262 300 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'OG003', 'title': 'GSK1838262 Placebo Match', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.50', 'spread': '0.745', 'groupId': 'OG000'}, {'value': '-12.54', 'spread': '0.764', 'groupId': 'OG001'}, {'value': '-11.48', 'spread': '0.767', 'groupId': 'OG002'}, {'value': '-9.93', 'spread': '0.753', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.57', 'ciLowerLimit': '-4.62', 'ciUpperLimit': '-0.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.745', 'estimateComment': 'The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.', 'groupDescription': 'The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'No adjustment for multiplicity will be made for these analyses.'}, {'pValue': '0.014', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.61', 'ciLowerLimit': '-4.68', 'ciUpperLimit': '-0.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.764', 'estimateComment': 'The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.', 'groupDescription': 'The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'No adjustment for multiplicity will be made for these analyses.'}, {'pValue': '0.144', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.55', 'ciLowerLimit': '-3.63', 'ciUpperLimit': '0.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.767', 'estimateComment': 'The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate', 'groupDescription': 'The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'No adjustment for multiplicity will be made for these analyses.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.\n\nChange from Baseline = LOCF value at current visit - value at Baseline (the last nonmissing assessment before the first dose of study medication). A negative treatment difference indicates a benefit relative to placebo.\n\nThe change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.'}, {'type': 'PRIMARY', 'title': 'The Proportion of Subjects at the End of Treatment Who Are Responders With Either "Much Improved" or "Very Much Improved" on the Investigator-rated Clinical Global Impression of Improvement (CGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1838262 600 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'OG001', 'title': 'GSK1838262 450 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'OG002', 'title': 'GSK1838262 300 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'OG003', 'title': 'GSK1838262 Placebo Match', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.26', 'ciLowerLimit': '1.30', 'ciUpperLimit': '3.95', 'estimateComment': 'The analysis method used was logistic regression with terms of pooled site and treatment.', 'groupDescription': 'The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with "much improved" or "very much improved" on the investigator-rated CGI-I at the end of treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.007', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.15', 'ciLowerLimit': '1.23', 'ciUpperLimit': '3.77', 'estimateComment': 'The analysis method used was logistic regression with terms of pooled site and treatment.', 'groupDescription': 'The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with "much improved" or "very much improved" on the investigator-rated CGI-I at the end of treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.005', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.24', 'ciLowerLimit': '1.27', 'ciUpperLimit': '3.94', 'estimateComment': 'The analysis method used was logistic regression with terms of pooled site and treatment.', 'groupDescription': 'The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with "much improved" or "very much improved" on the investigator-rated CGI-I at the end of treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 12 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT (modified intent to treat) population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.'}, {'type': 'SECONDARY', 'title': 'The Dose-response Relationship of Change From Baseline in IRLS Rating Scale Total Score at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1838262 600 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'OG001', 'title': 'GSK1838262 450 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'OG002', 'title': 'GSK1838262 300 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'OG003', 'title': 'GSK1838262 Placebo Match', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.1', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-12.7', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '-11.3', 'spread': '0.83', 'groupId': 'OG002'}, {'value': '-9.8', 'spread': '0.80', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For the mean change from Baseline for IRLS Rating Scale total score at the EOT, the linear contrast test based on an analysis of variance with treatment effect was used to detect linear dose-response trends across increasing levels of GEn dosage.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.072', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Overall treatment effect', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.\n\nThis model only includes treatment in the model. Least squares mean is used for analysis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.'}, {'type': 'SECONDARY', 'title': 'The Dose-response Relationship for Investigator-rated CGI-I Scale at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1838262 600 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'OG001', 'title': 'GSK1838262 450 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'OG002', 'title': 'GSK1838262 300 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'OG003', 'title': 'GSK1838262 Placebo Match', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': 'Non-Responder', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'A significant p-value will indicate a nonzero linear effect across increasing levels of GEn dosage.', 'statisticalMethod': 'Cochran-Armitage trend test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GSK1838262 600 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'FG001', 'title': 'GSK1838262 450 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'FG002', 'title': 'GSK1838262 300 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'FG003', 'title': 'GSK1838262 Placebo Match', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '125'}, {'groupId': 'FG002', 'numSubjects': '125'}, {'groupId': 'FG003', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '94'}, {'groupId': 'FG003', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '459', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'GSK1838262 600 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'BG001', 'title': 'GSK1838262 450 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'BG002', 'title': 'GSK1838262 300 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'BG003', 'title': 'GSK1838262 Placebo Match', 'description': 'Once-daily dose with food in the evening at approximately 5 PM'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.2', 'spread': '12.92', 'groupId': 'BG000'}, {'value': '52.1', 'spread': '12.22', 'groupId': 'BG001'}, {'value': '52.0', 'spread': '14.51', 'groupId': 'BG002'}, {'value': '52.1', 'spread': '13.01', 'groupId': 'BG003'}, {'value': '51.3', 'spread': '13.20', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '277', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '182', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}, {'value': '413', 'groupId': 'BG004'}]}]}, {'title': 'White & African American/African Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'White & Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Unknown or not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'IRLS Rating Scale Total Score, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.4', 'spread': '5.61', 'groupId': 'BG000'}, {'value': '24.0', 'spread': '5.23', 'groupId': 'BG001'}, {'value': '23.7', 'spread': '5.25', 'groupId': 'BG002'}, {'value': '23.5', 'spread': '5.34', 'groupId': 'BG003'}, {'value': '23.6', 'spread': '5.35', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.'}}, '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': 501}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-30', 'studyFirstSubmitDate': '2012-06-14', 'resultsFirstSubmitDate': '2014-07-14', 'studyFirstSubmitQcDate': '2012-08-16', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-10', 'studyFirstPostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change From Baseline to the End of Treatment in the International Restless Legs Syndrome (IRLS) Rating Scale Score', 'timeFrame': 'Baseline, 12 weeks', 'description': 'International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.\n\nChange from Baseline = LOCF value at current visit - value at Baseline (the last nonmissing assessment before the first dose of study medication). A negative treatment difference indicates a benefit relative to placebo.\n\nThe change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.'}, {'measure': 'The Proportion of Subjects at the End of Treatment Who Are Responders With Either "Much Improved" or "Very Much Improved" on the Investigator-rated Clinical Global Impression of Improvement (CGI-I)', 'timeFrame': '12 weeks', 'description': 'Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 12 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.'}], 'secondaryOutcomes': [{'measure': 'The Dose-response Relationship of Change From Baseline in IRLS Rating Scale Total Score at End of Treatment', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.\n\nThis model only includes treatment in the model. Least squares mean is used for analysis.'}, {'measure': 'The Dose-response Relationship for Investigator-rated CGI-I Scale at End of Treatment', 'timeFrame': '12 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gabapentin enacarbil', 'Horizant'], 'conditions': ['Restless Legs Syndrome']}, 'descriptionModule': {'briefSummary': 'Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently approved in the United States for the treatment of adults with moderate-to-severe primary Restless Legs Syndrome (RLS). The aim of this study is to compare the efficacy, tolerability, and safety of GEn at lower doses (450 and 300 mg/day) as well as the already approved dose of 600 mg/day versus placebo for the treatment of subjects with moderate to severe primary RLS. This study is being conducted as a post-marketing commitment (PMC) as a condition of the approval of HORIZANT tablets (NDA 022399).', 'detailedDescription': "This is a Phase IV randomized, double-blind, placebo-controlled, fixed-dose, parallel group study to assess the efficacy, tolerability, and safety of 3 doses of GEn (600, 450, and 300 mg/day) compared with placebo in the treatment of subjects with moderate-to-severe primary RLS.\n\nThe study will include 9 visits over approximately 14 weeks for eligible subjects including a 1-week Screening Period, a 12-week Treatment Period, and a 1 week Follow up Period. Screening will occur within 1 week of the first scheduled dose of study medication. The total duration of the study, from the first subject enrolled to the last subject completed will be approximately 2 years.\n\nEligible subjects (at least 18 years of age) must have:\n\n* a diagnosis of RLS according to the IRLSSG Diagnostic Criteria\n* a history of RLS symptoms for at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started\n* documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights during the Screening Period, and a total RLS severity score of at least 15 on the International Restless Legs Syndrome (IRLS) Rating Scale at the screening and baseline visits\n\nApproximately 498 subjects will be enrolled, randomly assigned to treatment groups, and receive study medication once daily for 12 weeks. Subjects will be randomly assigned to receive 1 of the 4 following treatment groups in a ratio of 1:1:1:1:\n\n* GEn 600 mg/day\n* GEn 450 mg/day\n* GEn 300 mg/day\n* Matching placebo\n\nSubjects will be instructed to take their study medication once daily with food in the evening at approximately 5 PM. Each tablet must be swallowed whole and not divided, crushed, or chewed.\n\nEach subject, regardless of treatment assignment, will take 3 tablets of study medication (1 tablet from Bottle A, 1 tablet from Bottle B, and 1 tablet from Bottle C) once daily continuing through the end of the Treatment Period (Week 12). Subjects will return to the study site for a follow-up visit (Visit 9, Week 13) approximately 1 week after the last dose of study medication.\n\nEach subject's participation in the study will be approximately 14 weeks unless they withdraw early from the study. For subjects who complete the study, Visit 9 (which can occur between Day 86 and 92) will be considered their end-of-study visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women 18 years of age or older\n* History of RLS symptoms for at least 15 nights/month\n* Documented RLS symptoms, using the 7-day RLS Symptom Record, for at least 4 of the 7 consecutive evenings/nights during the night\n* Total RLS severity score of 15 or greater on the International RLS (IRLS) Rating Scale at Visit 1 and at Visit 2\n* Discontinuation of dopamine agonists and/or gabapentin , or other treatments for RLS (e.g. opioids, benzodiazepines) at least 2 weeks prior to Baseline\n* If taking any prescription medication, therapy must have been stabilized for at least 3 months prior to Screening with no anticipated changes for the duration of the study\n* Female subjects are eligible if of non-childbearing potential or not lactating, has a negative pregnancy, and agrees to use a highly effective method for avoiding pregnancy\n* Body mass index of 34 or below\n* Estimated creatinine clearance of ≥60 mL/min\n* Provides written consent in accordance with all applicable regulatory requirements\n\nExclusion Criteria:\n\n* History of a sleep disorder that may affect the assessment of RLS\n* History of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment\n* Neurologic disease or movement disorder\n* Other medical conditions or drug therapy that could affect RLS efficacy assessments or may present a safety concern\n* Have clinically significant or unstable medical conditions\n* Have active suicidal plan/intent or has had active suicidal thoughts in the past 6 months; has a history of suicide attempt'}, 'identificationModule': {'nctId': 'NCT01668667', 'acronym': 'CONCORD', 'briefTitle': 'Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'XenoPort, Inc.'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group Study to Compare the Efficacy, Tolerability, and Safety of 3 Doses of Gabapentin Enacarbil (GSK1838262) With Placebo in Treatment of Moderate-to-Severe Primary RLS', 'orgStudyIdInfo': {'id': '114025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GSK1838262 600 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM', 'interventionNames': ['Drug: GSK1838262 600 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GSK1838262 450 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM', 'interventionNames': ['Drug: GSK1838262 450 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GSK1838262 300 mg', 'description': 'Once-daily dose with food in the evening at approximately 5 PM', 'interventionNames': ['Drug: GSK1838262 300 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'GSK1838262 placebo match', 'description': 'Once-daily dose with food in the evening at approximately 5 PM', 'interventionNames': ['Drug: GSK1838262 Placebo match']}], 'interventions': [{'name': 'GSK1838262 600 mg', 'type': 'DRUG', 'otherNames': ['Horizant', 'gabapentin enacarbil GEn', 'XP13512'], 'description': 'Drug: GSK1838262 600 mg/day Comparison of 3 doses', 'armGroupLabels': ['GSK1838262 600 mg']}, {'name': 'GSK1838262 450 mg', 'type': 'DRUG', 'otherNames': ['Horizant', 'gabapentin enacarbil GEn', 'XP13512'], 'description': 'Drug: GSK1838262 450 mg/day Comparison of 3 doses', 'armGroupLabels': ['GSK1838262 450 mg']}, {'name': 'GSK1838262 300 mg', 'type': 'DRUG', 'otherNames': ['Horizant', 'gabapentin enacarbil GEn', 'XP13512'], 'description': 'Drug: GSK1838262 300 mg/day Comparison of 3 doses', 'armGroupLabels': ['GSK1838262 300 mg']}, {'name': 'GSK1838262 Placebo match', 'type': 'DRUG', 'description': 'Drug; GSK1838262 placebo to match 600 mg, 450 mg, 300 mg doses', 'armGroupLabels': ['GSK1838262 placebo match']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'GSK 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'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45255', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44130', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '73112', 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