Summary

for males ages 6-11 (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

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).

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

Keywords

Duchenne Muscular Dystrophy muscular dystrophy Duchenne's Muscular Dystrophy DMD Muscular Dystrophies Muscular Dystrophy, Duchenne RO7239361, dose 1 RO7239361, dose 2

Eligibility

You can join if…

Open to males ages 6-11

  • 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

You CAN'T join if...

  • 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

  • University of California Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Stanford University accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
Links
FDA Safety Alerts and Recalls
Provides information about the Roche clinical trial NCT03039686 and molecule being investigated in Duchenne
Sign up for this study
ID
NCT03039686
Phase
Phase 2/3
Study Type
Interventional
Last Updated