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Troriluzole in Adult Participants With Spinocerebellar Ataxia

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 53 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study completion date: Jun 2026 to Aug 2026v53
  2. Study completion date: Oct 2025 to Jun 2026v52
  3. Results first posted: Feb 10, 2025v51 Show 6 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 218 to 299
    • Interventions: Placebos (Drug), troriluzole (Drug) to Placebo (Drug), troriluzole (Drug)
    • Secondary endpoints revised (4)
    • Study title revised
    • Eligibility criteria shortened, about 5 words
  4. Study completion date: Dec 22, 2024 to Oct 2025v50
  5. 2 versions Re-verified since Oct 4, 2022, no change to tracked fieldsv48-v49
Show 44 earlier versionsHide 44 earlier versions
  1. Primary completion date: Apr 29, 2022 to Feb 18, 2022v47
  2. Primary completion date changed from estimate of Apr 8, 2022 to Apr 29, 2022v46
  3. Primary completion date: Mar 7, 2022 to Apr 8, 2022
    • Study completion date: Jan 22, 2024 to Dec 22, 2024
    v45
  4. Primary completion date: Nov 30, 2021 to Mar 7, 2022
    • Study completion date: Nov 30, 2021 to Jan 22, 2024
    v44
  5. Enrollment target: estimated 210 to confirmed 218v43
  6. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 23 of 23 sites
    v42
  7. Site details revised at 1 of 23 sitesv41
  8. Site details revised at 1 of 23 sitesv40
  9. Site details revised at 1 of 23 sitesv39
  10. Site details revised at 1 of 23 sitesv38
  11. Primary and study completion dates: Oct 31, 2020 to Nov 30, 2021v37
  12. Study sites: 21 to 23v36
  13. Site contacts updated at 2 of 21 sitesv35
  14. Site details revised at 1 of 21 sitesv34
  15. Site details revised at 1 of 21 sitesv33
  16. Primary endpoint revised
    • Enrollment target: 230 to 210
    • Secondary endpoints: 10 to 4
    • Eligibility criteria shortened, about 4 words
    v32
  17. Site details revised at 1 of 21 sitesv31
  18. Site details revised at 1 of 21 sitesv30
  19. Study sites: 20 to 21v29
  20. Site details revised at 1 of 20 sitesv28
  21. Site contacts updated at 1 of 20 sitesv27
  22. Site contacts updated at 1 of 20 sitesv26
  23. Site contacts updated at 1 of 20 sitesv25
  24. Site details revised at 1 of 20 sitesv24
  25. Site details revised at 1 of 20 sitesv23
  26. Site details revised at 1 of 20 sitesv22
  27. Site details revised at 1 of 20 sitesv21
  28. Site details revised at 1 of 20 sitesv20
  29. Site details revised at 1 of 20 sitesv19
  30. Eligibility criteria expanded, about 27 wordsv18
  31. Site details revised at 1 of 20 sitesv17
  32. Site details revised at 2 of 20 sitesv16
  33. Site details revised at 1 of 20 sitesv15
  34. Site details revised at 1 of 20 sitesv14
  35. Site details revised at 1 of 20 sitesv13
  36. Site details revised at 1 of 20 sitesv12
  37. Site details revised at 1 of 20 sitesv11
  38. Study sites: 18 to 20v10
  39. Site contacts updated at 1 of 18 sitesv9
  40. Site details revised at 1 of 18 sitesv8
  41. Start date changed from estimate of Mar 15, 2019 to Mar 8, 2019v7
  42. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Eligibility criteria expanded, about 92 words
    • Secondary endpoints revised (10)
    • Site details revised at 18 of 18 sites
    • Study title revised
  43. Start date: Jan 31, 2019 to Mar 15, 2019v5
  44. Start date: Nov 15, 2018 to Jan 31, 2019v4
  • 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 compare the efficacy of Troriluzole (200 mg once daily) versus placebo after 48 weeks of treatment in subjects with spinocerebellar ataxia (SCA).
Trial Details
NCT Number NCT03701399
Lead Sponsor Biohaven Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Spinocerebellar Ataxias, Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3, Spinocerebellar Ataxia Type 6, Spinocerebellar Ataxia Type 7, Spinocerebellar Ataxia Type 8, Spinocerebellar Ataxia Type 10
Related terms Ataxia, Heart Arrest, Machado-Joseph Disease, Spinocerebellar Ataxia 10, Spinocerebellar ataxia 8, Spinocerebellar Ataxias
Enrollment 299 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov