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Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Active, Not Recruiting to Recruiting Site details revised at 39 of 39 sitesv20 Show 1 more changeShow less
    • Site details revised at 39 of 39 sites
  2. Primary and study completion dates: Dec 2025 to Dec 2029 Trial status: Enrolling by Invitation to Active, Not Recruitingv19 Show 1 more changeShow less
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
  3. Primary and study completion dates: Dec 2023 to Dec 2025v18
  4. Enrollment target: 194 to 206v17
  5. Enrollment target: 183 to 194 Study sites: 38 to 39v16 Show 1 more changeShow less
    • Study sites: 38 to 39
Show 14 earlier versionsHide 14 earlier versions
  1. Enrollment target: 156 to 183 Study sites: 36 to 38v15 Show 1 more changeShow less
    • Study sites: 36 to 38
  2. Enrollment target: 151 to 156 Study sites: 34 to 36v14 Show 1 more changeShow less
    • Study sites: 34 to 36
  3. Enrollment target: 100 to 151 Study sites: 28 to 34v13 Show 1 more changeShow less
    • Study sites: 28 to 34
  4. Study sites: 25 to 28v12
  5. Trial status: Recruiting to Enrolling by Invitation Study sites: 20 to 25v11 Show 1 more changeShow less
    • Study sites: 20 to 25
  6. Study sites: 18 to 20 Eligibility criteria revised · Study description revisedv10 Show 2 more changesShow less
    • Eligibility criteria revised
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 10 to 18 Eligibility criteria expanded, about 214 wordsv9 Show 1 more changeShow less
    • Eligibility criteria expanded, about 214 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 8 to 10v8
  9. Eligibility criteria shortened, about 1 word Study description shortened, about 1 wordv7 Show 1 more changeShow less
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 4 to 8 Eligibility criteria expanded, about 98 words · Study description expanded, about 152 wordsv6 Show 2 more changesShow less
    • Eligibility criteria expanded, about 98 words
    • Study description expanded, about 152 words

    See this version in full on ClinicalTrials.gov ↗

  11. Re-verified, no change to tracked fieldsv5
  12. Site contacts updated at 4 of 4 sitesv4
  13. Re-verified, no change to tracked fieldsv3
  14. Study title shortened, about 2 wordsv2 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 an open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD (Duchenne's muscular dystrophy) patients who have been previously treated in one of the GIVINOSTAT studies.
Trial Details
NCT Number NCT03373968
Lead Sponsor Italfarmaco
Collaborators: Cromsource
Conditions Duchenne Muscular Dystrophy
Enrollment 206 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov