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)

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Trial Summary
Trial Overview
Inclusion Criteria

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).


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
Yale University School of Medicine ; Pulmonary & Critical Care
20 York Street
New Haven, Connecticut 06510
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Kennedy Krieger Institute
707 North Broadway
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
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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University of Iowa
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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Children's Hospital of Philadelphia
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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Rare Disease Research, LLC
Atlanta, Georgia 30318
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Atlanta, GA
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Instituto Centenario
3855 Avenida Rivadavia
Buenos Aires, C1204AAD
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Buenos Aires,
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Rush University Medical Center - PPDS
1653 West Congress Parkway
Chicago, Illinois 60612
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Chicago, IL
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Cincinnati Childrens Hospital Medical Center;Investigational Pharmacy
3333 Burnet Avenue
Cincinnati, Ohio 45229
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Cincinnati, OH
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Nationwide Childrens Hospital; Research Institute at Nationwide Childrens Hospital
700 Children's Drive
Columbus, Ohio 43205
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Columbus, OH
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University of Kansas Medical Center
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Las Vegas Clinic
Las Vegas, Nevada 89145
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Las Vegas, NV
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Arkansas Children's Hospital; Pediatrics
Little Rock, Arkansas 72202
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Little Rock, AR
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David Geffen School of Medicine at UCLA; Clinical Trials Contract Unit
10833 Le Conte Avenue
Los Angeles, California 90095
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Los Angeles, CA
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Nemours Children's Hospital
13535 Nemours Parkway
Orlando, Florida 32827
(407) 567-4000
Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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Orlando, FL
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Stanford University
Palo Alto, California 94304
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Palo Alto, CA
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Neuromuscular Research Center
Phoenix, Arizona 85028
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Phoenix, AZ
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University of California, Davis Medical Center
2315 Stockton Blvd.
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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Saint Louis Children's Hospital
Saint Louis, Missouri 63110
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Saint Louis, MO
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Seattle Children's Hospital
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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University of Massachusetts Memorial Childrens Medical Center; Department of Neurology
Worcester, Massachusetts 01655
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Worcester, MA
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