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

Stopped early · Phase 3

Conditions studied: Fabry Disease

In brief

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.

Key facts

Study ID

NCT01458119

Run by

Amicus Therapeutics

People needed

85

Starts

2011-10-14

Expected to finish

2016-02-17

Last updated by the study team

2018-10-02

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed migalastat treatment in a previous Fabry disease protocol
• Both male and female participants were enrolled
• Age 16 years or older
• Male and female participants had to agree to use protocol-identified acceptable contraception

You may not qualify if…

• Estimated glomerular filtration rate (eGFR) in the previous study was <30 milliliters/minute/1.73 square meters (mL/min/1.73 m\^2) unless there was a measured GFR available within 3 m of the Baseline Visit that was >30 mL/min/1.73 m\^2
• Had undergone, or was scheduled to undergo, kidney transplantation or was currently on dialysis
• Pregnant or breast feeding
• Treated with another investigational drug (except migalastat) within 30 days of study start
• Unable to comply with study requirements, or deemed otherwise unsuitable for study entry, in the opinion of the investigator
• Had documented transient ischemic attack, stroke, unstable angina, or myocardial infarction within the 12 m before the Baseline Visit
• Had clinically significant, unstable cardiac disease in the opinion of the investigator
• Had a history of allergy or sensitivity to migalastat (including excipients) or to other iminosugars
• Required treatment with Glyset (miglitol) or Zavesca (miglustat)
• Had any intercurrent illness or condition that may have precluded the participant from fulfilling the protocol requirements
• Had a severe or unsuitable concomitant medical condition
• Had a clinically significant abnormal laboratory value and a clinically significant electrocardiogram finding at the Baseline Visit.

Where it is running

• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — Boston, Massachusetts, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — New York, New York, United States
• Study site — Portland, Oregon, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Fairfax, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Pilar, Argentina
• Study site — Adelaide, Australia
• Study site — Parkville, Australia
• Study site — Edegem, Belgium
• Study site — Porto Alegre, Brazil
• Study site — Montreal, Canada
• Study site — Copenhagen, Denmark
• Study site — Cairo, Egypt
• Study site — Garches, France
• Study site — Roma, Italy
• Study site — Barcelona, Spain
• Study site — Ankara, Turkey (Türkiye)
• Study site — London, United Kingdom
• Study site — Salford, United Kingdom

Full record on ClinicalTrials.gov

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