At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 16 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.
A Long-term, Open-label Study to Evaluate the Safety, Pharmacodynamics, and Efficacy of Migalastat in Subjects > 12 Years of Age With Fabry Disease and Amenable GLA Variants
In Brief
A Phase 3 clinical trial evaluating migalastat HCl 150 mg for Fabry Disease. Completed, enrolled 16 participants across 6 sites in 2 countries.
Detailed Summary
This is a long-term, Open-label Study to Evaluate the Safety, Pharmacodynamics, and Efficacy of Migalastat in Subjects \> 12 Years of Age With Fabry Disease and Amenable GLA Variants
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesUnited Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartOct 2019
Primary CompletionNov 2024
TodayJul 2026
First PostedAug 8, 2019
Enrollment StartOct 11, 2019
Primary CompletionNov 29, 2024
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 6.9 years ago
Interventions
migalastat HCl 150 mgdrug
migalastat HCl 150 mg capsule