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Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy
Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy

NCT03039686

CompletedPhase 2, Phase 3

Sponsor: Hoffmann-La Roche

Conditions: Duchenne Muscular Dystrophy

Interventions: RO7239361, Placebo for RO7239361

Countries: United States, Argentina, Australia, Belgium, Canada, France, Germany, Italy

This is a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of two different weekly doses of RO7239361 in ambulatory boys with Duchenne Muscular Dystrophy (DMD).

Eligibility overview

Sex: MALE

Age: 6 Years to 11 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Diagnosed with DMD by confirmed medical history and genetic testing
* Able to walk without assistance
* Minimum North Star Ambulatory Assessment score of 15 at screening
* Able to walk up 4 stairs in 8 seconds or less
* Weigh at least 15 kg (33 lbs)
* Taking corticosteroids for DMD

Exclusion Criteria:

* Any behavior or mental issue that will affect the ability to complete the required study procedures
* Previously or currently taking medications like androgens or human growth hormone
* Use of a ventilator during the day
* Unable to have blood samples collected or receive an injection under the skin
* Concomitant or previous participation at any time in a gene therapy study

Other protocol defined Inclusion/Exclusion Criteria could apply.
Locations (44)
  • Phoenix, Arizona, United States
  • Palo Alto, California, United States
  • Sacramento, California, United States
  • New Haven, Connecticut, United States
  • Gainesville, Florida, United States
  • Orlando, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Iowa City, Iowa, United States
  • Kansas City, Kansas, United States
  • Baltimore, Maryland, United States
  • Worcester, Massachusetts, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • Cincinnati, Ohio, United States
  • Columbus, Ohio, United States
  • Seattle, Washington, United States
  • Buenos Aires, Argentina
  • Westmead, New South Wales, Australia
  • South Brisbane, Queensland, Australia
  • Parkville, Victoria, Australia
  • Ghent, Belgium
  • London, Ontario, Canada
  • Ottawa, Ontario, Canada
  • Lyon, France
  • Nantes, France
  • Paris, France
  • Strasbourg, France
  • Essen, Germany
  • Milano, Emilia-Romagna, Italy
  • + 14 more on CT.gov