At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 67 enrolled
Drug / intervention
migalastat hydrochloride +1 moredrug
Likely dose
Not stated in 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 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamics of AT1001 in Patients With Fabry Disease and AT1001-Responsive GLA Mutations
In Brief
A Phase 3 clinical trial evaluating migalastat hydrochloride and Placebo for Fabry Disease. Completed, enrolled 67 participants across 28 sites in 13 countries.
Detailed Summary
The primary objective of this study was to compare the effect of migalastat (123 milligrams \[mg\] of migalastat \[equivalent to 150 mg of migalastat hydrochloride\]) (migalastat) versus placebo on kidney globotriaosylceramide (GL-3).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesArgentina, Australia, Brazil, Canada, Denmark, Egypt, France, Italy, Poland, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartOct 2009
Primary CompletionJun 2012
Study CompletionJan 2014
TodayJul 2026
First PostedJun 22, 2009
Enrollment StartOct 23, 2009
Primary CompletionJun 12, 2012
Study CompletionJan 29, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.0 years ago
Interventions
migalastat hydrochloridedrug
Oral capsule QOD
Placebodrug
Oral capsule QOD