Open-Label Phase 3 Long-Term Safety Study of Migalastat
(AT1001-041 Trial)
Recruiting in Palo Alto (17 mi)
+24 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Amicus Therapeutics
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This was a long-term, open-label study of migalastat (123 milligrams \[mg\] of migalastat \[equivalent to 150 mg of migalastat hydrochloride\]) (migalastat) in participants with Fabry disease who completed treatment in a previous monotherapy trial with migalastat.
Research Team
MM
Medical Monitor, Clinical Research
Principal Investigator
Amicus Therapeutics
Eligibility Criteria
Inclusion Criteria
Completed migalastat treatment in a previous Fabry disease protocol
Both male and female participants were enrolled
Age 16 years or older
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Treatment Details
Interventions
- Migalastat Hydrochloride (Chaperone Therapy)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: MigalastatExperimental Treatment1 Intervention
Migalastat 150-mg capsule taken orally QOD. The median duration of exposure was 23.5 m.
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Who Is Running the Clinical Trial?
Amicus Therapeutics
Lead Sponsor
Trials
55
Recruited
2,700+