A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's Disease



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:25 - 65
Updated:3/22/2019
Start Date:January 23, 2019
End Date:August 1, 2022
Contact:Reference Study ID Number: BN40423 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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A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's Disease

This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042)
compared with placebo in patients with manifest Huntington's disease (HD).


Inclusion Criteria:

- Manifest HD diagnosis, defined as a DCL score of 4

- Independence Scale (IS) score >= 70

- Genetically confirmed disease by direct DNA testing with a CAP score >400

- Clinical assessment to ensure individual has intact functional independence at
baseline to maintain self-care and core activities of daily living (ADLs).

Exclusion Criteria:

- Any serious medical condition or clinically significant laboratory, or vital sign
abnormality at screening that, in the investigator's judgment, precludes the patient's
safe participation in and completion of the study

- Pregnant or breastfeeding, or intending to become pregnant during the study or within
5 months after the final dose of study drug
We found this trial at
21
sites
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Baltimore, Maryland 21287
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1876 5th Avenue South
Birmingham, Alabama 35233
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Edmonton, Alberta
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Englewood, Colorado 80113
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Evanston, Illinois 60208
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Kirkland, Washington 98034
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Palo Alto, California 94304
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Pasadena, California 91105
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Phoenix, Arizona 85013
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2315 Stockton Boulevard
Sacramento, California 95817
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Washington, District of Columbia 20007
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3980 Sheridan Drive
Williamsville, New York 14221
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