Last updated on January 2020

A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER

Brief description of study

This is a Phase 3, 12-week, multi-Center, multi-national, randomized, double-blind, double-dummy, parallel-group study to determine the effectiveness, safety and tolerability of P2B001 taken once daily compared to its individual components in adults with early Parkinson's disease (PD) and to a calibration arm of Pramipexole ER. A total of 525 eligible subjects with early untreated Parkinson's disease will be randomized to 4 treatment groups. Each subject will participate in the study for approximately 18 weeks including a 30-day screening period, 12-week treatment period, and 2-week follow-up period.

Clinical Study Identifier: TX207230

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