P2B001 for Early Stage Parkinson’s Disease
P2B001 is currently in Phase III clinical trial. This is a twelve-week, randomized, double-blind, double-dummy, 4-arm, parallel group, multi-center, multinational study to determine the efficacy, safety and tolerability of P2B001 in subjects with early PD as compared to its individual components and compared to a calibration arm of pramipexole ER.
A total of 525 early stage untreated PD patients will be randomized to 4-arms of treatment with: P2B001, a once daily (pramipexole 0.6mg / rasagiline 0.75 mg), or to pramipexole 0.6 mg once daily, or to rasagiline 0.75 mg once daily, or to pramipexole ER titrated to optimal dose (1.5, 3.0 or 4.5mg) using a randomization scheme of 2:2:2:1, respectively. Subjects will be recruited from approximately 70 sites in North America and Europe.
For information regarding P2B001 on-going phase III clinical study, please see: https://clinicaltrials.gov/ct2/show/NCT03329508