At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 137 enrolled
Drug / intervention
placebo +5 moredrug
Likely dose
Pregabalin 50 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.
Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted May 13, 2008·Updated Feb 10, 2021
In Brief
A Phase 2 clinical trial evaluating placebo and Pregabalin for Restless Legs Syndrome. Completed, enrolled 137 participants across 25 sites in 4 countries.
Detailed Summary
To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome
CountriesAustria, Germany, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedMay 2008
Primary CompletionJan 2009
TodayJul 2026
First PostedMay 13, 2008
Enrollment StartApr 1, 2008
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.1 years ago
Interventions
placebodrug
Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks
Pregabalindrug
50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Pregabalindrug
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Pregabalindrug
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Pregabalindrug
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Pregabalindrug
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks