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A Study of Migalastat in Pediatric Subjects (2 to <12 Yrs) With Fabry Disease and Amenable GLA Variants

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 11 to 12v12
  2. Site details revised at 1 of 11 sitesv11
  3. Site details revised at 1 of 11 sitesv10
  4. Study sites: 9 to 11v9
  5. Start date changed from estimate of Dec 2025 to Jan 8, 2026
    • Site details revised at 2 of 9 sites
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Oct 2025 to Dec 2025
    • Study sites: 7 to 9
    v7
  2. Study sites: 1 to 7v6
  3. Start date: Jul 2025 to Oct 2025v5
  4. Start date: Jun 2025 to Jul 2025v4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Start date: May 2025 to Jun 2025
    • Secondary endpoints: details revised at 1 of 9 entries
    • Site details revised
    • Eligibility criteria shortened, about 1 word
    • Study description shortened, about 1 word
  6. Study Identification, Study Status, Contacts/Locationsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
An open-label study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of migalastat treatment in pediatric subjects 2 to \< 12 years of age with Fabry disease and with amenable GLA variants.
Trial Details
NCT Number NCT06904261
Lead Sponsor Amicus Therapeutics
Conditions
(from sponsor)		 Fabry Disease
Related terms Fabry Disease
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov