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A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

Study acronym: RISE 2
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 80 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Trial sites reduced: 124 → 104 locations
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 8 of 8 entries
  2. Site details revised at 10 of 124 sitesv79
  3. Site details revised at 1 of 124 sitesv78
  4. Site details revised at 1 of 124 sitesv77
  5. Study sites: 125 to 124
    • Interventions: BHV-7000 (Drug), BHV-7000 (Drug), Placebo (Drug) to BHV-7000 (Drug), BHV-7000 (Drug), BHV-7000 (Drug), Placebo (Drug), Placebo (Drug)
    • Secondary endpoints revised (8)
    • Study arms: 3 to 5
    v76
Show 45 earlier versionsHide 45 earlier versions
  1. Primary completion date: Aug 2025 to Dec 2026
    • Study sites: 124 to 125
    • Study completion date: Sep 2025 to Dec 2026
    v75
  2. Site details revised at 1 of 124 sitesv74
  3. Site details revised at 1 of 124 sitesv73
  4. Study sites: 123 to 124v72
  5. Site details revised at 2 of 123 sitesv71
  6. Site details revised at 1 of 123 sitesv70
  7. Study sites: 122 to 123v69
  8. Site details revised at 3 of 122 sitesv68
  9. Study sites: 120 to 122v67
  10. Site details revised at 1 of 120 sitesv66
  11. Site details revised at 1 of 120 sitesv65
  12. Site details revised at 1 of 120 sitesv64
  13. Study sites: 118 to 120v63
  14. Eligibility criteria shortened, about 17 words
    • Site details revised at 2 of 118 sites
    v62
  15. Site details revised at 1 of 118 sitesv61
  16. Site details revised at 3 of 118 sitesv60
  17. Site details revised at 1 of 118 sitesv59
  18. Site details revised at 1 of 118 sitesv58
  19. Site details revised at 2 of 118 sitesv57
  20. Site details revised at 1 of 118 sitesv56
  21. Site details revised at 1 of 118 sitesv55
  22. Site details revised at 1 of 118 sitesv54
  23. Site details revised at 3 of 118 sitesv53
  24. Site details revised at 2 of 118 sitesv52
  25. Site details revised at 1 of 118 sitesv51
  26. Site details revised at 22 of 118 sitesv50
  27. Site details revised at 2 of 118 sitesv49
  28. Site details revised at 1 of 118 sitesv48
  29. Site details revised at 1 of 118 sitesv47
  30. Site details revised at 1 of 118 sitesv46
  31. Site details revised at 2 of 118 sitesv45
  32. Site details revised at 2 of 118 sitesv44
  33. Site details revised at 1 of 118 sitesv43
  34. Site details revised at 1 of 118 sitesv42
  35. Site details revised at 1 of 118 sitesv41
  36. Site details revised at 1 of 118 sitesv40
  37. Site details revised at 1 of 118 sitesv39
  38. Site details revised at 1 of 118 sitesv38
  39. Site details revised at 1 of 118 sitesv37
  40. Study sites: 105 to 118v36
  41. Study sites: 104 to 105v35
  42. Study sites: 91 to 104v34
  43. Study sites: 88 to 91v33
  44. Study sites: 64 to 88v32
  45. Site details revised at 1 of 64 sitesv31
  • 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.
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Trial Details
NCT Number NCT06132893
Lead Sponsor Biohaven Therapeutics Ltd.
Conditions
(from sponsor)		 Focal Epilepsy
Related terms Drug Resistant Epilepsy, Epilepsies, Partial, Epilepsy, Seizures
Enrollment 390 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov