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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Biohaven Therapeutics Ltd.
Study ID
NCT06976268
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • BHV-8000 10mg — DRUG
    taken orally
  • BHV-8000 20 mg — DRUG
    taken orally
  • Placebo — DRUG
    taken orally

Study Details

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.

Key Dates

First listed
May 16, 2025
Start date
May 28, 2025
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BHV-8000 10 mg
    Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP. Open-label Phase: Participants will receive BHV-8000.
  • Experimental: BHV-8000 20 mg
    Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP. Open-label Phase: Participants will receive BHV-8000.
  • Placebo Comparator: Placebo
    Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP (matching placebo). Open-label Phase: Participants will receive BHV-8000.

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 ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Site-049BirminghamAlabama35294-
Site-041Los AngelesCalifornia90033-
Site-031FarmingtonConnecticut06030-
Site-028New HavenConnecticut06510-
Site-038AtlantisFlorida33462-
Site-017Boca RatonFlorida33486-
Site-051MaitlandFlorida32751-
Site-027ChicagoIllinois60611-
Site-071BostonMassachusetts02114-
Site-015Farmington HillsMichigan48334-
Site-044ChesterfieldMissouri63005-
Site-005New YorkNew York10021-
Site-091PortlandOregon97210-
Site-043Round RockTexas78681-
Site-007BellevueWashington98007-

Find similar trials in Birmingham, AL

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Site-049· Birmingham, ALSite-041· Los Angeles, CASite-031· Farmington, CTSite-028· New Haven, CTSite-038· Atlantis, FLSite-017· Boca Raton, FL

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