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Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy

Study acronym: ULYSSES
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 2 of 29 sitesv14
  2. Study sites: 20 to 29v13
  3. Site details revised at 1 of 20 sitesv12
  4. Site details revised at 2 of 20 sitesv11
  5. Site details revised at 4 of 20 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Site details revised at 1 of 20 sitesv9
  2. Study sites revised (20)v8 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (20)v7 See this version in full on ClinicalTrials.gov ↗
  4. Site details revised at 5 of 20 sitesv6
  5. Site details revised at 1 of 20 sites Publications: 2 to 3 · Collaborators expanded, about 1 wordv5 Show 2 more changesShow less
    • Publications: 2 to 3
    • Collaborators expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Site details revised at 20 of 20 sitesv4
  7. Trial status: Not Yet Recruiting to Recruiting Primary endpoint revised · Primary and study completion dates: Dec 2027 to Feb 2028 · Start date changed from estimate of Dec 2023 to Feb 19, 2024 · 3 morev3 Show 6 more changesShow less
    • Primary endpoint revised
    • Primary and study completion dates: Dec 2027 to Feb 2028
    • Start date changed from estimate of Dec 2023 to Feb 19, 2024
    • Eligibility criteria expanded, about 142 words
    • Secondary endpoints expanded, about 114 words
    • Study description expanded, about 347 words

    See this version in full on ClinicalTrials.gov ↗

  8. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy, safety, and tolerability of givinostat in non-ambulant male paediatric (aged 9 to \<18 years) patients with DMD. 138 patients will be randomised 2:1 to givinostat or placebo and will be treated for 18 months. * Planned screening duration: approximately 4 weeks (±14 days) * Planned treatment duration: 18 months (approximately 72 weeks) * Planned follow-up duration: 4 weeks (±7 days) (for patients not participating in the long-term safety study) * Total duration of study participation: up to 83 weeks (ie, 20-21 months)
Trial Details
NCT Number NCT05933057
Lead Sponsor Italfarmaco
Collaborators: Fortrea
Conditions Duchenne Muscular Dystrophy
Enrollment 138 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov