Conditions: Restless Legs Syndrome
Keywords: Moderate Restless Legs Syndrome Severe ropinirole
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 404
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Double-blind (Ropinirole:Placebo) for 12 to 26 weeks arm 2: Open label ropinirole for 40 weeks

Interventions: intervention 1: Placebo intervention 2: Ropinirole
Intervention descriptions: intervention 1: Matching Placebo intervention 2: Ropinirole IR 0.25mg/day to 4mg/day for RLS

Protocol document: