Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 6 - 11 |
| Updated: | 3/21/2019 |
| Start Date: | July 6, 2017 |
| End Date: | December 17, 2024 |
| Contact: | Reference Study ID Number: WN40227 www.roche.com/about_roche/roche_worldwide.htm |
| Email: | global-roche-genentech-trials@gene.com |
| Phone: | 888-662-6728 (U.S. and Canada) |
A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy
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).
efficacy, safety and tolerability of two different weekly doses of RO7239361 in ambulatory
boys with Duchenne Muscular Dystrophy (DMD).
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.
We found this trial at
21
sites
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707 North Broadway
Baltimore, Maryland 21205
Baltimore, Maryland 21205
443-923-9200
Phone: 443-923-9515
Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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3333 Burnet Avenue
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
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700 Children's Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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10833 Le Conte Avenue
Los Angeles, California 90095
Los Angeles, California 90095
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20 York Street
New Haven, Connecticut 06510
New Haven, Connecticut 06510
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Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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2315 Stockton Blvd.
Sacramento, California 95817
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Worcester, Massachusetts 01655
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