Evaluating BHV-8000 for treating early Parkinson's disease in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy, safety, and tolerability of BHV-8000 in adults diagnosed with early Parkinson's disease. Participants aged 40 to 85 will be enrolled if they meet specific diagnostic criteria for probable Parkinson's disease and have had symptoms for no more than two years. The study will involve administering either BHV-8000 or a placebo to evaluate its effects on the condition. The goal is to determine if this treatment can improve patient outcomes in the early stages of Parkinson's disease.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Male or female participants 40 to 80 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 \[in any form, e.g., tobacco smoke, electronic cigarettes, etc.\] )
* Treatment with PD medication(s)
* 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.

Where it's running

• Site-049
  Birmingham, Alabama, United States Recruiting
• Site-079
  Sun City, Arizona, United States Recruiting
• Site-003
  Irvine, California, United States Recruiting
• Site-041
  Los Angeles, California, United States Recruiting
• Site-025
  Aurora, Colorado, United States Recruiting
• Site-031
  Farmington, Connecticut, United States Recruiting

Study contacts

• Study coordinator: Chief Medical Officer
• Email: clinicaltrials@biohavenpharma.com
• Phone: 203-404-0410

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.