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Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 5 of 9 sitesv3
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2025 to Jan 2, 2025 · Site details revised at 9 of 9 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2025 to Jan 2, 2025
    • Site details revised at 9 of 9 sites
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 2 Open-label (Core Phase Plus Extension Phase) With 2 Cohorts Study to Assess the Pharmacokinetics and Safety of Givinostat in younger DMD Patients. * Planned screening duration: approximately 4 weeks * Planned Core Treatment duration: approximately 48 weeks * Planned Extension Treatment duration: approximately 96 weeks * Planned Follow Up duration: approximately 4 weeks (± 7 days) * Total duration of study participation: up to 151 weeks (ie, 37-38 months)
Trial Details
NCT Number NCT06769633
Lead Sponsor Italfarmaco
Collaborators: Fortrea
Conditions Duchenne Muscular Dystrophy
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov