Overview

Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease

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 assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). A successful switch at a specific visit is defined as no worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by more than 15% from baseline and no drug-related adverse events leading to withdrawal; - To establish if this successful switch can be obtained with or without dose-adaptation; - To provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER.
Phase:
Phase 3
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Pramipexole