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Open-Label Phase 3 Long-Term Safety Study of Migalastat

NCT01458119 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2018-10-02

Study results available
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Summary

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.

Conditions

Interventions

DRUG

migalastat hydrochloride

Oral capsule QOD

Sponsors & Collaborators

  • Amicus Therapeutics

    lead INDUSTRY

Principal Investigators

  • Medical Monitor, Clinical Research · Amicus Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-14
Primary Completion
2016-02-17
Completion
2016-02-17

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Denmark
  • Egypt
  • France
  • Italy
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01458119 on ClinicalTrials.gov