Last updated on October 2017

An Open-label Extension Study To Evaluate Safety Of PF-06252616 In Boys With Duchenne Muscular Dystrophy


Brief description of study

This study is an open-label extension to protocol B5161002 and will provide an assessment of the long term safety, efficacy, pharmacodynamics and pharmacokinetics of intravenous dosing of PF 06252616 in boys with Duchenne muscular dystrophy. Approximately 105 eligible subjects will be assigned to receive a monthly individualized maximum tolerated dose based on their tolerability profile/data from B5161002. This study will not contain a placebo comparator. Subjects will undergo safety evaluations (Laboratory, cardiac monitoring, physical exams, x-ray, MRI), functional capacity evaluations (4 stair climb, range of motion, strength testing, Northstar Ambulatory Assessment, upper limb functional testing, six minute walk test and pulmonary function tests) and pharmacokinetic testing.

Clinical Study Identifier: NCT02907619

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David Geffen School of Medicine at UCLA/UCLA Neorology
Los Angeles, CA United States
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Ronald Reagan UCLA Medical Center
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Ronald Reagan UCLA Pharmacy
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UCLA (David Geffen School of Medicine), Department of Orthopedic Surgery
Los Angeles, CA United States
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UCLA Clinical & Translational Research Center
Los Angeles, CA United States
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University of Iowa ICTS, Clinical Research Unit
Iowa City, IA United States
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Kennedy Krieger Institute Out-patient Center
Baltimore, MD United States
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Kennedy Krieger Institute
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Johns Hopkins Hospital
Baltimore, MD United States
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Johns Hopkins Investigational Drug Service
Baltimore, MD United States
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Duke University Medical Center, Lenox Baker Children's Hospital
Durham, NC United States
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Duke University, Investigational Drug Pharmacy
Durham, NC United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, OH United States
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Children's Hospital of Pittsburgh of UPMC
Pittsburgh, PA United States
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Alberta Children's Hospital
Calgary, AB Canada
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Children's Hospital- London Health Sciences Centre
London, ON Canada
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National Center of Neurology and Psychiatry
Kodaira, Japan
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Dubowitz Neuromuscular Centre, Institute of Child Health
London, United Kingdom
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Great Ormond Street Hospital
London, United Kingdom
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Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
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Institute of Genetic Medicine,Muscle Team
Newcastle-upon-Tyne, United Kingdom
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Clinical Research Facility
Newcastle-upon-Tyne, United Kingdom
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