Conditions: Restless Legs Syndrome
Keywords: restless legs syndrome RLS polysomnography PSG sleep disturbance patient reported outcome
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 85
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: pregabalin intervention 2: placebo intervention 3: pramipexole
Intervention descriptions: intervention 1: capsules; 300 mg once-per-day; 4 weeks of treatment intervention 2: capsules; 0 mg once-per-day; 4 weeks of treatment intervention 3: capsules; 0.5 mg once-per-day; 4 weeks of treatment

Protocol document: