ClinicalTrials.gov Identifier: NCT03329508
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
This study is planned to see how effective and how safe a new investigational medication named P2B001 is in 525 adults in North America and Europe with early Parkinson’s disease.
All subjects receive an active study treatment, one of four that are being compared. There is no placebo arm in the study.
Who may be eligible to participate?
Subjects who were recently diagnosed with Parkinson's disease, are between the ages 35 and 75 and have not been taking other Parkinson’s disease medication for more than 4 weeks.
What does participation involve?
The study includes seven visits to the study center during approximately 14 to 18 weeks.
The study involves taking study medications once-daily for 13 weeks.
The study team will be monitoring subjects’ condition and will be available for subjects if they have any questions.
Subjects will be asked to attend all scheduled visits, follow the study doctor’s instructions and take study drugs as directed; to not participate in any other clinical trials, while participating in this study and to inform the study doctor of any changes in their health or medication, whether or not they think they are related to the study drugs.
Daniel Burdick, MD, Booth Gardner Parkinson’s Care Center