NCT00329602

Long-term Study Of Ropinirole In Restless Legs Syndrome

A Parallel Group Study to Evaluate the Efficacy and Safety of Ropinirole for 26 Weeks and to Further Evaluate the Incidence of Augmentation and Rebound for a Further 40 Weeks Open-label Extension Treatment Period in Subjects Suffering From Moderate to Severe Restless Legs Syndrome.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome.

Detailed description

A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open-label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Placebo	Matching Placebo
DRUG	Ropinirole	Ropinirole IR 0.25mg/day to 4mg/day for RLS

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2006-05-25
• Last updated: 2017-03-23
• Results posted: 2010-05-27

Locations

39 sites across 11 countries: Australia, Czechia, Denmark, Germany, Italy, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland