Conditions: Idiopathic Restless Legs Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 154
Healthy volunteers: no

Brief summary:
The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label phase in this trial is to investigate the long term safety and efficacy of pramipexole in RLS.

Detailed description:

Arms:
arm 1: Pramipexole 0.25 mg given once daily arm 2: Pramipexole 0.5 mg given once daily arm 3: Pramipexole 0.75 mg given once daily

Interventions: intervention 1: Pramipexole 0.125 mg tablet intervention 2: Pramipexole 0.5 mg tablet
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: