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A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints removed 9 → 3 primary endpoints
See other at-risk trials from Ono Pharmaceutical Co., Ltd.

Record History

  1. Primary endpoint(s) modified Results posted: Oct 6, 2026 · Eligibility criteria expanded, about 14 words · Secondary endpoint revised · 1 more Show 4 more changesShow less
    • Results posted: Oct 6, 2026
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoint revised
    • Site details revised at 3 of 35 sites
  2. Completion pushed from Jan 1, 2027 to Oct 31, 2027 Secondary endpoints: 2 to 1 · Study description expanded, about 9 wordsv11 Show 2 more changesShow less
    • Secondary endpoints: 2 to 1
    • Study description expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  3. Sponsor changed: Ono Pharmaceutical Co. Ltd to Ono Pharmaceutical Co., Ltd. Primary completion date changed from estimate of Aug 31, 2025 to Sep 15, 2025 · Completion date: Aug 31, 2025 to Jan 1, 2027 · Study description expanded, about 53 words · 1 morev10 Show 4 more changesShow less
    • Primary completion date changed from estimate of Aug 31, 2025 to Sep 15, 2025
    • Completion date: Aug 31, 2025 to Jan 1, 2027
    • Study description expanded, about 53 words
    • Site details revised at 1 of 35 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv9
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 80 to confirmed 92 · Study sites: 36 to 35v8 Show 2 more changesShow less
    • Enrollment target: estimated 80 to confirmed 92
    • Study sites: 36 to 35
Show 6 earlier versionsHide 6 earlier versions
  1. Re-verified, no change to tracked fieldsv7
  2. Study sites: 16 to 36 Eligibility criteria shortened, about 21 wordsv6 Show 1 more changeShow less
    • Eligibility criteria shortened, about 21 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 3 of 16 sitesv5
  4. Re-verified, no change to tracked fieldsv4
  5. Study sites: 6 to 16v3
  6. Trial status: Not Yet Recruiting to Recruiting Primary endpoints revised (9) · Study sites: 1 to 6 · Start date changed from estimate of Jul 15, 2023 to Sep 22, 2023 · 2 morev2 Show 5 more changesShow less
    • Primary endpoints revised (9)
    • Study sites: 1 to 6
    • Start date changed from estimate of Jul 15, 2023 to Sep 22, 2023
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

  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.
This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of multiple doses of ONO-2808 in patients with MSA. This is the first study of ONO-2808 in patients with MSA.
Trial Details
NCT Number NCT05923866
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Conditions Multiple System Atrophy (MSA)
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov