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NCT Number: NCT06976268

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

A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease. The study will consist of a 48-week double-blind treatment phase followed by a 48-week open-label phase.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Site-049, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BHV-8000 10mg

Drug

taken orally

BHV-8000 20 mg

Drug

taken orally

Placebo

Drug

taken orally

Primary outcomes

  1. Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II

    Time frame: Up to 48 Weeks

    To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the time to prespecified worsening on MDS-UPDRS Part II (motor experiences of daily living per self-administered questionnaire). MDS-UPDRS Part II is a 52-point scale with a higher total score representing more severe disability.

Secondary outcomes

  1. Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III from Baseline to Week 48 of the DB Phase

    Time frame: Baseline to Week 48

    To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the change in MDS-UPDRS Part III (motor examination conducted by rater). MDS-UPDRS Part III is a 132-point scale with a higher total score representing a greater degree of motor impairment.

  2. Change in Clinical Global Impression of Severity (CGI-S) from Baseline to Week 48 of the DB Phase

    Time frame: Baseline to Week 48

    To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the change in severity of a participant's illness as determined by the managing clinician. The CGI-S is a 7-point scale (1 - 7) with 7 representing the most extremely ill participants.

  3. Change in DaT-SPECT scan from Baseline to Week 48 of the DB Phase

    Time frame: Baseline to Week 48

    To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by change in DaT-SPECT Striatal Binding Ratio (SBR) in the putamen (assessing the activity of the dopamine transporters). Reduced uptake of the radiotracer is indicative of a decreased number of dopamine-secreting cells and suggestive of disease progression.

  4. Change in Parkinson's Disease Composite Score - Function (PARCOMS-Function) from Baseline to Week 48 of the DB Phase

    Time frame: Baseline to Week 48

    To compare the efficacy of BHV-8000 compared to placebo. This objective is measured by changes in the Parkinson's Disease Composite Score - Function (PARCOMS-Function) score. The PARCOMS-Function is a composite of select items taken from the MDS-UPDRS Part II and the PDQ-39© (assessing ability to complete daily activities). The PARCOMS-Function is a 100-point scale (0 - 100) with higher scores representing greater dysfunction.

  5. Number of Participants with Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs

    Time frame: Up to 96 weeks

    To assess the safety and tolerability of BHV-8000. This objective will be measured by assessing the number of unique participants with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs

  6. Number of participants with clinically significant laboratory abnormalities

    Time frame: Up to 96 weeks

    To assess the safety and tolerability of BHV-8000. This objective will be measured by assessing the number of unique participants with treatment-emergent Grade 3 and 4 laboratory abnormalities

Study contacts

Contact information is provided by the study sponsor or research team.

Chief Medical Officer

CONTACT

[email protected]

203-404-0410

Sponsors and collaborators

Lead sponsor

Biohaven Therapeutics Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 16, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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