A Phase 3 Study With P2B001 in Subjects With Early Parkinson's

Brief Summary:
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.

Detailed Description:
A total of 525 eligible subjects with early untreated Parkinson's disease (PD), 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 weeks follow-up period.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 4 arms
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double blind study
Primary Purpose: Treatment
Official Title: A Phase 3, Twelve-week 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.
Actual Study Start Date: January 29, 2018
Estimated Primary Completion Date: March 30, 2020
Estimated Study Completion Date: September 30, 2020

Arms:
- Experimental: P2B001
- Experimental: rasagiline capsule
- Experimental: Pramipexole capsule
- Active Comparator: Pramipexole Extended Release