Pivotal Study in Advanced Parkinsons Disease Patients
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The general aim of this trial is to determine the efficacy (as measured by the change from
baseline to the end of the maintenance phase in the total score for Unified Parkinsons
Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER,
in daily doses from 0.375 milligram to 4.5 milligram once a day, in comparison to placebo, in
Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with
advanced Parkinsons Disease and motor fluctuations.
In addition, a numerical comparison of the efficacy of pramipexole extended release versus
pramipexole immediate release will be done.
The efficacy of pramipexole immediate release will also be compared to placebo, for assay
sensitivity.