Find participating medical centers and current study status in each of them
Find participating medical centers
-
Home
-
Clinical Trial Finder
- Clinical Trial Details
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)
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 2/Phase 3
Trial Identifier
NCT03039686, CN001-016, 2016-001654-18,WN40227
Condition
Duchenne Muscular Dystrophy, Duchenne Muscular Dystrophy
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
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).
Eligibility Criteria
Male
≥6 Years & ≤ 11 Years
No
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.
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
Explore related studies
For the latest version of this information please go to www.forpatients.roche.com