Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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