A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease
Biohaven Therapeutics Ltd.
Summary
A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease.
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Male or female participants 40 to 85 years of age, inclusive, at the time of informed consent. * Meet the diagnostic criteria for "Probable PD" as assessed on the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD as assessed by the Investigator. * Have a clinician-documented diagnosis of idiopathic PD with an onset within 2 years of the Screening Visit Key Exclusion Criteria: * Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including, but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, dr…
Interventions
- DrugBHV-8000
BHV-8000 10 mg. Participants will take blinded investigational product (IP) once daily
- DrugBHV-8000
BHV-8000 20 mg. Participants will take blinded investigational product (IP) once daily
- DrugPlacebo
Matching placebo taken once daily
Locations (15)
- Site-049Birmingham, Alabama
- Site-041Los Angeles, California
- Site-031Farmington, Connecticut
- Site-028New Haven, Connecticut
- Site-038Atlantis, Florida
- Site-017Boca Raton, Florida