Conditions: Parkinson Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 312
Healthy volunteers: no

Brief summary:
Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo.

Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among the treatment groups over 12 weeks

Detailed description:

Arms:
arm 1: None arm 2: Pramipexole 0.5 mg tid (three times a day) arm 3: Pramipexole 0.5 mg bid (bis in die (two times a day)) arm 4: Pramipexole 0.75 mg bid (bis in die (two times a day))

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

Protocol document: