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Trials / Recruiting

RecruitingNCT06976268

A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease

A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease

Status
Recruiting
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
550 (estimated)
Sponsor
Biohaven Therapeutics Ltd. · Industry
Sex
All
Age
40 Years – 85 Years
Healthy volunteers
Not accepted

Summary

A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease.

Conditions

Interventions

TypeNameDescription
DRUGBHV-8000BHV-8000 10 mg. Participants will take blinded investigational product (IP) once daily
DRUGBHV-8000BHV-8000 20 mg. Participants will take blinded investigational product (IP) once daily
DRUGPlaceboMatching placebo taken once daily

Timeline

Start date
2025-05-28
Primary completion
2027-08-01
Completion
2027-09-01
First posted
2025-05-16
Last updated
2026-01-14

Locations

15 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06976268. Inclusion in this directory is not an endorsement.

A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson' (NCT06976268) · Clinical Trials Directory