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Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 10 entries Completion pushed from Jan 31, 2027 to Jan 31, 2031 · Eligibility criteria expanded, about 4 words Show 2 more changesShow less
    • Completion pushed from Jan 31, 2027 to Jan 31, 2031
    • Eligibility criteria expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv11
  3. Site details revised at 1 of 2 sitesv10
  4. Primary and study completion dates: Mar 31, 2024 to Jan 31, 2027v9
  5. Primary and study completion dates: Mar 31, 2023 to Mar 31, 2024v8
Show 6 earlier versionsHide 6 earlier versions
  1. Re-verified, no change to tracked fieldsv7
  2. Primary and study completion dates: Mar 31, 2022 to Mar 31, 2023v6
  3. Start date: Jul 8, 2020 to Jun 30, 2020v5
  4. Trial status: Enrolling by Invitation to Active, Not Recruitingv4
  5. Study sites: 1 to 2 Start date: Jul 1, 2020 to Jul 8, 2020v3 Show 1 more changeShow less
    • Start date: Jul 1, 2020 to Jul 8, 2020
  6. Trial status: Not Yet Recruiting to Enrolling by Invitation Primary endpoints revised (10) · Study sites: 0 to 1 · Study title expanded, about 2 wordsv2 Show 3 more changesShow less
    • Primary endpoints revised (10)
    • Study sites: 0 to 1
    • Study title expanded, about 2 words

    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter, open-label, long-term, extension, phase 2 study to evaluate the safety and efficacy of long-term treatment with DS-5141b in patients with DMD who have completed DS5141-A-J101.
Trial Details
NCT Number NCT04433234
Lead Sponsor Daiichi Sankyo Co., Ltd.
Conditions Duchenne Muscular Dystrophy
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov