RECRUITING

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

Conditions

Parkinson Disease Early Parkinson's Disease Parkinson's Disease Early onset Parkinson's Disease treatment naiive early Parkinson's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-05

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06976268

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Chief Medical Officer

CONTACT

203-404-0410

clinicaltrials@biohavenpharma.com

Study Locations (Sites)

Site-017

Boca Raton, Florida, 33486

United States

Site-015

Farmington Hills, Michigan, 48334

United States

Collaborators and Investigators

Sponsor: Biohaven Therapeutics Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05

Study Completion Date2027-09

Study Record Updates

Study Start Date2025-05

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

Early Parkinson's Disease
Parkinson's Disease
Early onset Parkinson's Disease
treatment naiive early Parkinson's Disease

Additional Relevant MeSH Terms

Parkinson Disease