At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 85 enrolled
Drug / intervention
pregabalin +2 moredrug
Likely dose
pregabalin 300 mgfrom 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.
A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover, Multicenter Polysomnography Study Of Pregabalin And Pramipexole In Adults With Restless Legs Syndrome
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Oct 7, 2009·Updated Feb 15, 2021
In Brief
A Phase 3 clinical trial evaluating pregabalin, placebo, and 1 other intervention for Restless Legs Syndrome. Completed, enrolled 85 participants across 41 sites.
Detailed Summary
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartDec 2009
Primary CompletionJun 2011
TodayJul 2026
First PostedOct 7, 2009
Enrollment StartDec 1, 2009
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.7 years ago
Interventions
pregabalindrug
capsules; 300 mg once-per-day; 4 weeks of treatment
placebodrug
capsules; 0 mg once-per-day; 4 weeks of treatment
pramipexoledrug
capsules; 0.5 mg once-per-day; 4 weeks of treatment