Drug Treatment Study for Boys with Duchenne Muscular Dystrophy

Clinical Trial Title

A multi-site, randomized, placebo-controlled, double-blind, multiple ascending subcutaneous dose study to evaluate the safety, tolerability and pharmcokinetics of BMS-986089 in ambulatory boys with Duchenne muscular dystrophy.

Contact Information

Susan Rohde

Clinical Trial Protocol Description:

The purpose of this study is to assess the safety and tolerability of an anti-myostatin adnectin called BMS-986089 in ambulatory boys with genetically confirmed Duchenne muscular dystrophy (DMD).

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Be male, 5 to 10 years old and ambulatory without assistance.
  • Weigh at least 15 kg.
  • Have a diagnosis of DMD, confirmed by genotyping.
  • Are receiving corticosteroids (eg, prednisone, prednisolone, or deflazacort) for at least 6 months prior to the start of study drug administration.

You will be excluded from the study if any of the following criteria apply to you:

  • Have a history of current renal disease.
  • Have ejection fraction < 55% on screening echocardiogram.
  • Have known cognitive impairment or behavioral issues that will compromise ability to comply with study procedure.
  • Have uncontrolled clinical signs and symptoms of chronic heart failure (American College of Cardiology/American Heart Associated Stage C or D).

This is a partial list of inclusion and exclusion criteria.

Study Details

Clinical Trial Investigator

Peter T. Heydemann, MD

Contact Information

Susan Rohde

(312) 942-0079

Location

Rush University Medical Center

1620 W Harrison St
Chicago, IL 60612

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