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

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 22 to 24
  2. Primary endpoints: details revised at 1 of 1 entry
    • Trial sites expanded: 19 → 22 locations
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 6 of 6 entries
  3. Study sites: 18 to 19v23
  4. Study sites: 17 to 18v22
  5. Study sites: 16 to 17v21
  6. Study sites: 15 to 16v20
  7. Study completion pushed from Sep 2027 to Sep 2028
    • Interventions: BHV-8000 (Drug), BHV-8000 (Drug), Placebo (Drug) to BHV-8000 10mg (Drug), BHV-8000 20 mg (Drug), Placebo (Drug)
    • Eligibility criteria revised
    • Secondary endpoints revised (6)
    v19
  8. Study sites: 14 to 15v18
  9. Study sites: 13 to 14v17
  10. Study sites: 67 to 13v16
  11. Re-verified, no change to tracked fieldsv15
  12. Study sites: 65 to 67
    • Eligibility criteria shortened, about 28 words
    v14
  13. Site details revised at 1 of 65 sitesv13
  14. Site details revised at 1 of 65 sitesv12
  15. Site details revised at 1 of 65 sitesv11
  16. Site details revised at 2 of 65 sitesv10
  17. Study sites: 5 to 65v9
  18. Site details revised at 1 of 5 sitesv8
  19. Site details revised at 1 of 5 sitesv7
  20. Study sites: 3 to 5v6
  21. Study sites: 2 to 3v5
  22. Site details revised at 1 of 2 sitesv4
  23. Start date changed from estimate of May 2025 to May 28, 2025v3
  24. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v2
  25. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06976268
Lead Sponsor Biohaven Therapeutics Ltd.
Conditions
(from sponsor)		 Parkinson Disease
Related terms Parkinson Disease
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov