At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IR
In Brief
A Phase 3 clinical trial evaluating Pramipexole Extended Release and Pramipexole Immediate Release for Parkinson Disease. Completed, enrolled 156 participants across 36 sites in 3 countries.
Detailed 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.