At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double Blind, 12-Month Study Of Pregabalin In Subjects With Restless Legs Syndrome
In Brief
A Phase 3 clinical trial evaluating placebo and pregabalin, pramipexol, and 1 other intervention for Idiopathic Restless Legs Syndrome. Completed, enrolled 731 participants across 110 sites in 9 countries.
Detailed Summary
This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.
Study Details
Timeline
Interventions
following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime.
following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.
following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.
pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months