Conditions: Early Parkinson Disease (Early PD)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 539
Healthy volunteers: no

Brief summary:
The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III combined), safety, and tolerability of Pramipexole Extended Release (ER) (in daily doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority between the two formulations (ER and IR) of pramipexole.

In addition, the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo, for assay sensitivity

Detailed description:

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

Interventions: intervention 1: Pramipexol Extended Release intervention 2: Pramipexol Immediate Release intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: