A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Early Parkinson's Disease
- Parkinson Disease
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 4 armsMasking: Triple (Participant, Care Provider, Investigator)Masking Description: double blind studyPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 35 years and 80 years
- Gender
- Both males and females
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. Subjects will b...
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. Subjects will be requested to take one capsule and 1-3 tablets of study drug by mouth with a glass of water every day for 13 weeks. The study requires seven visits to the clinic one every 2-4 weeks.
Tracking Information
- NCT #
- NCT03329508
- Collaborators
- Not Provided
- Investigators
- Study Director: Pninit Litman Pharma2b LTD
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