Conditions: Restless Legs Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 306
Healthy volunteers: no

Brief summary:
To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)

Detailed description:

Arms:
arm 1: 4 weeks of individual dose titration starting with Pramipexole 0.125 mg, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily arm 2: 4 weeks of individual dose titration as for the investigational product, once daily

Interventions: intervention 1: Pramipexole intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: