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A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep ((CR-RLS))
The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 39 |
| Start date | 2006-10 |
| Completion | 2007-06 |
Conditions
- Restless Legs Syndrome (RLS)
- Restless Legs Syndrome
Interventions
- ropinirole CR-RLS
Primary outcomes
- Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12. — 12 Weeks
Countries
United States