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

  • Muscle And Peripheral Nerve Disease
  • Duchenne Muscular Dystrophy (DMD)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Countries
  • Argentina
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom
  • United States
Study Identifier:

NCT03039686 2016-001654-18 WN40227 CN001-016

      Show study locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study Summary

      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).

      Hoffmann-La Roche Sponsor
      Phase 2/Phase 3 Phase
      NCT03039686, CN001-016, 2016-001654-18,WN40227 Study Identifier
      RO7239361, Placebo for RO7239361 Treatments
      Duchenne Muscular Dystrophy, Duchenne Muscular Dystrophy Condition
      Official Title

      A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy

      Eligibility Criteria

      Male Gender
      ≥6 Years & ≤ 11 Years Age
      No Healthy Volunteers
      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.

      For the latest version of this information please go to www.forpatients.roche.com

       

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