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A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy

Study acronym: TOPAS-MSA
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fields
  2. Lead sponsor: Teva Branded Pharmaceutical Products R&D LLC to Teva Branded Pharmaceutical Products R&D LLC Enrollment closed, study ongoing · Enrollment target: estimated 350 to confirmed 349 · Eligibility criteria expanded, about 14 words · 2 more Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Enrollment target: estimated 350 to confirmed 349
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 3 of 19 entries
    • Site details revised at 61 of 61 sites
  3. Study sites: 60 to 61v39
  4. Study sites: 58 to 60v38
  5. Trial sites expanded: 55 → 58 locationsv37
Show 35 earlier versionsHide 35 earlier versions
  1. Study sites: 54 to 55v36
  2. Site details revised at 34 of 54 sitesv35
  3. Site details revised at 1 of 54 sitesv34
  4. Site details revised at 1 of 54 sitesv33
  5. Site details revised at 1 of 54 sitesv32
  6. Site details revised at 9 of 54 sitesv31
  7. Enrollment target: 200 to 350 Primary completion date: May 20, 2027 to Sep 15, 2027 · Completion date: Jun 17, 2027 to Sep 15, 2027 · Site details revised at 7 of 54 sites · 2 morev30 Show 5 more changesShow less
    • Primary completion date: May 20, 2027 to Sep 15, 2027
    • Completion date: Jun 17, 2027 to Sep 15, 2027
    • Site details revised at 7 of 54 sites
    • Study description expanded, about 1 word
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 53 to 54v29
  9. Study sites: 52 to 53v28
  10. Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc. to Teva Branded Pharmaceutical Products R&D LLC Site details revised at 3 of 52 sitesv27 Show 1 more changeShow less
    • Site details revised at 3 of 52 sites
  11. Re-verified, no change to tracked fieldsv26
  12. Primary endpoints: 1 to 2 Eligibility criteria shortened, about 27 words · Secondary endpoints: 10 to 19v25 Show 2 more changesShow less
    • Eligibility criteria shortened, about 27 words
    • Secondary endpoints: 10 to 19

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites: 50 to 52v24
  14. Study sites: 49 to 50v23
  15. Study sites: 48 to 49v22
  16. Study sites: 46 to 48v21
  17. Study sites: 45 to 46v20
  18. Site details revised at 4 of 45 sitesv19
  19. Study sites: 43 to 45v18
  20. Study sites: 42 to 43v17
  21. Study sites: 38 to 42v16
  22. Study sites: 34 to 38v15
  23. Study sites: 32 to 34v14
  24. Study sites: 29 to 32v13
  25. Study sites: 27 to 29v12
  26. Study sites: 26 to 27v11
  27. Study sites: 24 to 26v10
  28. Study sites: 19 to 24v9
  29. Study sites: 17 to 19v8
  30. Study sites: 13 to 17v7
  31. Study sites: 6 to 13v6
  32. Study sites: 3 to 6v5
  33. Study sites: 2 to 3v4
  34. Study description expanded, about 17 words Study title expanded, about 2 wordsv3 Show 1 more changeShow less
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  35. Primary completion date: May 18, 2027 to May 20, 2027 Completion date: Jun 15, 2027 to Jun 17, 2027 · Start date changed from estimate of Oct 1, 2024 to Oct 2, 2024v2 Show 2 more changesShow less
    • Completion date: Jun 15, 2027 to Jun 17, 2027
    • Start date changed from estimate of Oct 1, 2024 to Oct 2, 2024
  1. 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.
The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286. Another secondary objective is to evaluate the safety and tolerability of TEV-56286. The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.
Trial Details
NCT Number NCT06568237
Lead Sponsor Teva Branded Pharmaceutical Products R&D LLC
Conditions Multiple System Atrophy
Enrollment 349 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov