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Parkinson DiseasePhase 2/3NCT06976268

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

A Phase 2/3 study testing BHV-8000 10mg and BHV-8000 20 mg in people with Parkinson Disease, run by Biohaven Therapeutics Ltd. at 25 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
BHV-8000 10mg and BHV-8000 20 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
550 participants
Where
25 sitesUnited States
Study dates
28 May 2025to Sep 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chief Medical Officer contact

203-404-0410

clinicaltrials@biohavenpharma.com

25 sites in 1 country

United States25 sites, 25 recruiting

  • Site-006

    Albany, New York, 12208

    Recruiting

  • Site-038

    Atlantis, Florida, 33462

    Recruiting

  • Site-025

    Aurora, Colorado, 80045

    Recruiting

  • Site-007

    Bellevue, Washington, 98007

    Recruiting

  • Site-049

    Birmingham, Alabama, 35294

    Recruiting

  • Site-017

    Boca Raton, Florida, 33486

    Recruiting

  • Site-071

    Boston, Massachusetts, 02114

    Recruiting

  • Site-044

    Chesterfield, Missouri, 63005

    Recruiting

  • Site-027

    Chicago, Illinois, 60611

    Recruiting

  • Site-082

    Cleveland, Ohio, 44195

    Recruiting

  • Site-031

    Farmington, Connecticut, 06030

    Recruiting

  • Site-015

    Farmington Hills, Michigan, 48334

    Recruiting

  • Site-004

    Foxborough, Massachusetts, 02035

    Recruiting

  • Site-009

    Henrico, Virginia, 23233

    Recruiting

  • Site-003

    Irvine, California, 92618

    Recruiting

  • Site-029

    Kansas City, Kansas, 66160

    Recruiting

  • Site-041

    Los Angeles, California, 90033

    Recruiting

  • Site-051

    Maitland, Florida, 32751

    Recruiting

  • Site-028

    New Haven, Connecticut, 06510

    Recruiting

  • Site-005

    New York, New York, 10021

    Recruiting

  • Site-074

    Newport News, Virginia, 23601

    Recruiting

  • Site-091

    Portland, Oregon, 97210

    Recruiting

  • Site-043

    Round Rock, Texas, 78681

    Recruiting

  • Site-019

    Seattle, Washington, 98122

    Recruiting

  • Site-079

    Sun City, Arizona, 85351

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants 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.

Being tested
BHV-8000 10mg, BHV-8000 20 mg, Placebo
Keywords
Early Parkinson's Disease, Parkinson's Disease, Early stage Parkinson's Disease, treatment naiive early Parkinson's Disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BHV-8000 10mgDrug

    taken orally

  • BHV-8000 20 mgDrug

    taken orally

  • PlaceboDrug

    taken orally

Study groups in NCT06976268
Study groupRoleWhat they receive
BHV-8000 10 mgExperimentalDouble-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP. Open-label Phase: Participants will receive BHV-8000.
Receives: Drug: BHV-8000 10mg; Drug: BHV-8000 20 mg; Drug: Placebo
BHV-8000 20 mgExperimentalDouble-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP. Open-label Phase: Participants will receive BHV-8000.
Receives: Drug: BHV-8000 10mg; Drug: BHV-8000 20 mg; Drug: Placebo
PlaceboPlacebo comparatorDouble-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP (matching placebo). Open-label Phase: Participants will receive BHV-8000.
Receives: Drug: BHV-8000 10mg; Drug: BHV-8000 20 mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Up to 48 Weeks

Secondary outcomes (6)

  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

    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.

    Measured: Baseline to Week 48

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

    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.

    Measured: Baseline to Week 48

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

    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.

    Measured: Baseline to Week 48

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

    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.

    Measured: Baseline to Week 48

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

    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

    Measured: Up to 96 weeks

  6. Number of participants with clinically significant laboratory abnormalities

    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

    Measured: Up to 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2025
  2. Study start28 May 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06976268
Sponsor's protocol ID
BHV8000-301
Other IDs
2025-521113-13-00, 2025
Status last verified
Oct 2026
First submitted
9 May 2025
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BHV-8000 10mg and BHV-8000 20 mg in people with Parkinson Disease, run by Biohaven Therapeutics Ltd. at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chief Medical Officer (203-404-0410, clinicaltrials@biohavenpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06976268.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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