BHV-8000 in Participants with Early Parkinson’s Disease
Research type
Research Study
Full title
A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants with Early Parkinson’s Disease.
IRAS ID
1012050
Contact name
Raquel Vaquer
Contact email
Sponsor organisation
Biohaven Therapeutics, Ltd., c/o Biohaven Pharmaceuticals, Inc.(BPI)
Clinicaltrials.gov Identifier
Research summary
Parkinson's disease (PD) is a condition where certain parts of the brain and nervous system that help control movement and coordination do not work as well as they should. This can cause problems like shaking, stiffness, and difficulty moving. BHV-8000 is a new medicine being tested to help people with early PD.
This study will see if BHV-8000 can help people with early PD by slowing down the disease and improving their daily lives, while also evaluating its safety profile.
The study will consist of the following phases:
•Screening phase (up to 8 weeks)
•Double-blind phase (meaning that neither the participant nor the study doctors will know which treatment they are taking). (48 weeks: participants will be divided into 3 groups and will receive either oral tablets of BHV-8000 or placebo):
- Group 1: 10 mg BHV-8000 taken once a day for 48 weeks
- Group 2: 20 mg BHV-8000 taken once a day for 48 weeks
- Group 3: Placebo taken once a day for 48 weeks
•Follow-up phase (4 weeks)REC name
London - Riverside Research Ethics Committee
REC reference
25/LO/0728
Date of REC Opinion
2 Dec 2025
REC opinion
Further Information Favourable Opinion