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

Launched by BIOHAVEN THERAPEUTICS LTD. · May 9, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called BHV-8000 to see if it is effective, safe, and tolerable for adults with early Parkinson's disease. Parkinson's disease (PD) is a condition that affects movement and can cause symptoms like tremors and stiffness. The study will include men and women aged 40 to 85 who have been diagnosed with "probable" Parkinson's disease within the last two years. This means they have shown signs of the disease that doctors can recognize.

If you or someone you know is considering participating, it's important to know that potential participants will be screened to ensure they have the right type of Parkinson's disease and meet other health criteria. For example, individuals who have certain other conditions or have used Parkinson's medications for long periods will not be eligible. While the study is not yet recruiting participants, those who join can expect to be monitored closely to assess how well the treatment works and if it is safe for them. Overall, this trial aims to contribute valuable information about new treatment options for early Parkinson's disease.

Gender

ALL

Eligibility criteria

• 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, drug-induced Parkinsonism, essential tremor, or primary dystonia.
• • Diagnosis of clinically significant central nervous system (CNS) disease other than PD.
• • Participants who are current smokers (defined as smoking \[in any form, e.g., tobacco smoke, electronic cigarettes, etc.\] within 6 months prior to the Baseline Visit).
• • Treatment with PD medication(s) for a total of more than 28 days or treatment with any PD medication within 90 days of the Baseline Visit.
• • Any other condition(s) that may compromise participant safety, interfere with study conduct, or jeopardize the potential proper interpretation of study results, in the opinion of the investigator.