Study of ACE-083 in Patients With Facioscapulohumeral Muscular Dystrophy (FSHD)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Facioscapulohumeral Muscular Dystrophy
In brief
Study A083-02 is a multi-center, Phase 2 study to evaluate the safety, tolerability, pharmacodynamics (PD), efficacy, and pharmacokinetics (PK) of locally-acting ACE-083 in patients with Facioscapulohumeral muscular dystrophy (FSHD) to be conducted in two parts. Part 1 is open-label, dose-escalation and Part 2 is randomized, double-blind, and placebo-controlled.
Key facts
- Study ID
- NCT02927080
- Run by
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- People needed
- 95
- Starts
- 2016-11-01
- Expected to finish
- 2019-10-09
- Last updated by the study team
- 2022-09-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California Los Angeles Medical Center — Los Angeles, California, United States
- University of California Davis Medical Center — Sacramento, California, United States
- University of Colorado — Aurora, Colorado, United States
- Indiana University School of Medicine — Indianapolis, Indiana, United States
- University of Iowa — Iowa City, Iowa, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Johns Hopkins Hugo W. Moser Research Inst. at Kennedy Krieger Inc. — Baltimore, Maryland, United States
- Brigham & Women's Hospital — Boston, Massachusetts, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- University of Rochester School of Medicine — Rochester, New York, United States
- Carolinas Healthcare System Neurosciences Institute — Charlotte, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- The Ohio State University — Columbus, Ohio, United States
- Oregon Health & Science University — Portland, Oregon, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Utah — Salt Lake City, Utah, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
- University of Calgary — Calgary, Alberta, Canada
- London Health Sciences Centre — London, Ontario, Canada
- Montreal Neurological Institute & Hospital — Montreal, Quebec, Canada
- Hospital Universitario Vall d'Hebrón — Barcelona, Spain
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
- Hospital Universitario y Politécnico La Fe — Valencia, Spain
Full record on ClinicalTrials.gov
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