CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
migalastat HCldrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Males aged 18-55 years (inclusive)
  • ✓Hemizygous for Fabry disease
  • ✓Confirmed Fabry disease diagnosis with documented missense gene mutation (individual or familial)
  • ✓Demonstrable enhanceable enzyme activity
Key exclusion· 6
  • ✕Significant comorbidities: end-stage renal disease, NYHA Class III or IV heart disease, active cancer (except basal cell carcinoma), diabetes with HbA1c >8%, or neurological disease impairing participation
  • ✕Prior organ transplant
  • ✕Serum creatinine >2 mg/dL on Day -2
  • ✕Corrected QT interval >450 milliseconds on screening 12-lead ECG

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00214500
NCT00214500Phase 2Completed
CompareCT.gov

A Phase 2, Open-Label, Multicenter, 12-Week Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AT1001 in Patients With Fabry Disease

Amicus Therapeutics·interventional·Posted Sep 22, 2005·Updated Oct 30, 2018

In Brief

A Phase 2 clinical trial evaluating migalastat HCl for Fabry Disease. Completed, enrolled 9 participants across 5 sites.

Detailed Summary

Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartJan 2, 2006
Primary CompletionJan 29, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 20.8 years ago

Interventions

migalastat HCldrug