At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 375 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Gabapentin Enacarbil Post-marketing Clinical Study A Randomized, Double-blind, Placebo-controlled, Parallel-group Study in Subjects With Restless Legs Syndrome.
In Brief
A Phase 4 clinical trial evaluating Placebo and Gabapentin enacarbil for Restless Legs Syndrome (RLS). Completed, enrolled 375 participants across 46 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome (RLS)
CountriesJapan
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 2017
Enrollment StartMar 2017
Primary CompletionJun 2018
TodayJul 2026
First PostedFeb 15, 2017
Enrollment StartMar 30, 2017
Primary CompletionJun 25, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.4 years ago
Interventions
Placebodrug
Oral administration
Gabapentin enacarbildrug
Oral administration