Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05481879 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-101 in Participants With Myotonic Dystrophy Type 1

Study acronym: ACHIEVE
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Enrollment target: estimated 116 to confirmed 127
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 16 of 33 entries
    • Site details revised at 20 of 20 sites
  2. Trial sites expanded: 17 → 20 locationsv21
  3. Study sites: 16 to 17v20
  4. Site contacts updated at 1 of 16 sitesv19
  5. Study sites: 15 to 16v18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 14 to 15v17
  2. Site contacts updated at 1 of 14 sitesv16
  3. Study sites: 13 to 14v15
  4. Study sites: 9 to 13v14
  5. Primary endpoints revised (2)
    • Enrollment target: 104 to 116
    • Secondary endpoints: 25 to 33
    • Eligibility criteria expanded, about 3 words
    v13
  6. Primary and study completion dates: Jul 2026 to Jul 2029v12 Show 4 more changesShow less
    • Primary endpoints: 1 to 2
    • Secondary endpoints: 20 to 25
    • Site contacts updated at 1 of 9 sites
    • Study arms: 4 to 8
  7. Site contacts updated at 8 of 9 sitesv11
  8. Enrollment target: 72 to 104
    • Eligibility criteria expanded, about 101 words
    • Secondary endpoints: details revised at 3 of 20 entries
    v10
  9. Study sites: 8 to 9v9
  10. Study sites: 7 to 8v8
  11. Enrollment target: 64 to 72
    • Eligibility criteria shortened, about 14 words
    • Secondary endpoints: 19 to 20
    v7
  12. Study sites: 6 to 7v6
  13. Study sites: 4 to 6v5
  14. Study sites: 1 to 4
    • Start date changed from estimate of Aug 2022 to Sep 5, 2022
    v4
  15. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  16. Site contact updatedv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of the study is to evaluate the safety and tolerability of multiple intravenous (IV) doses of DYNE-101 administered to participants with Myotonic Dystrophy Type 1 (DM1). The study consists of 4 periods: A Screening Period (up to 8 weeks), a Placebo-Controlled Period (24 weeks), a Treatment Period (24 weeks) and a Long-Term Extension (LTE) Period (208 weeks) in both multiple-ascending dose (MAD) and dose expansion cohorts.
Trial Details
NCT Number NCT05481879
Lead Sponsor Dyne Therapeutics
Conditions
(from sponsor)		 Myotonic Dystrophy Type 1 (DM1)
Related terms Myotonic Dystrophy
Enrollment 127 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov