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) |
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).
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
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
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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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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University of South Florida The University of South Florida is a high-impact, global research university...
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6431 Fannin Street
Houston, Texas 77030
Houston, Texas 77030
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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660 S Euclid Ave
Saint Louis, Missouri 63110
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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