NCT00806026

Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

Randomized, Double Blind, 12-Month Study Of Pregabalin In Subjects With Restless Legs Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 731 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	placebo and pregabalin	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.
DRUG	pramipexol	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.
DRUG	pramipexol	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.
DRUG	Pregabalin	pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
DRUG	pramipexol	pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
DRUG	pramipexol	pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2008-12-10
• Last updated: 2021-01-26
• Results posted: 2012-09-27

Locations

110 sites across 9 countries: United States, Austria, Finland, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom