At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 84 enrolled
Drug / intervention
migalastat HCl 150 mgdrug
Likely dose
migalastat HCl 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects With Fabry Disease
In Brief
A Phase 3 clinical trial evaluating migalastat HCl 150 mg for Fabry Disease. Completed, enrolled 84 participants across 28 sites in 15 countries.
Detailed Summary
This is an open-label extension study intended to provide continued treatment with migalastat hydrochloride (HCl) for participants with Fabry disease who completed treatment of a previous migalastat HCl study. The study assessed the long-term safety and effectiveness of migalastat HCl.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Egypt, France, Italy, Japan, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartMar 2015
Primary CompletionOct 2019
TodayJul 2026
First PostedJul 21, 2014
Enrollment StartMar 14, 2015
Primary CompletionOct 23, 2019
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 11.9 years ago
Interventions
migalastat HCl 150 mgdrug
Migalastat HCl 150 mg (equivalent to 123 mg migalastat) was provided as capsules in blister packs. One capsule was taken orally every other day.