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Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 42 to 43
  2. Study sites: 40 to 42
  3. Study sites: 39 to 40
  4. Study sites: 37 to 39
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 21 entries
  5. Study sites: 36 to 37v19
  6. Study sites: 34 to 36v18
  7. Trial sites expanded: 25 → 33 locationsv17
  8. Study sites: 25 to 33v16
  9. Trial sites expanded: 21 → 24 locationsv15
  10. Study sites: 21 to 24v14
  11. Study sites: 20 to 21v13
  12. Study sites: 19 to 20v12
  13. Study sites: 18 to 19v11
  14. Study sites: 17 to 18v10
  15. Study sites: 15 to 17v9
  16. Study sites: 14 to 15v8
  17. Trial sites expanded: 11 → 14 locations
    • Trial sites expanded: 6 → 11 locations
    v7
  18. Study sites: 6 to 11
    • Start date changed from estimate of Apr 2026 to May 14, 2026
    v6
  19. Study sites: 5 to 6v5
  20. Study sites: 4 to 5v4
  21. Recruitment opened
    • Trial sites expanded: 0 → 4 locations
    • Site contacts updated at 1 of 4 sites
    v3
  22. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Interventions: DYNE-101 (Drug), Placebo (Drug) to Placebo (Drug), zeleciment basivarsen (DYNE-101) (Drug)
    • Study title expanded, about 2 words
    v2
  23. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of the study is to assess the efficacy, safety, and tolerability of zeleciment basivarsen (DYNE-101) for the treatment of myotonic dystrophy 1 (DM1).
Trial Details
NCT Number NCT07486934
Lead Sponsor Dyne Therapeutics
Conditions
(from sponsor)		 Myotonic Dystrophy Type 1 (DM1), DM1, Myotonic Dystrophy, Steinert Disease, Steinert
Related terms Myotonia, Myotonic Disorders, Myotonic Dystrophy
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov