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

Completed · Phase 3 · Has a placebo group

Conditions studied: Huntingtons Disease

In brief

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

Key facts

Study ID

NCT03761849

Run by

Hoffmann-La Roche

People needed

899

Starts

2019-01-23

Expected to finish

2022-03-24

Last updated by the study team

2024-03-01

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Any serious medical condition or clinically significant laboratory, or vital sign abnormality or claustrophobia 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

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• University of California San Diego — La Jolla, California, United States
• Stanford Univ Medical Center — Palo Alto, California, United States
• SC3 Research Group, Inc — Pasadena, California, United States
• University of California Davis Medical System — Sacramento, California, United States
• CenExel Rocky Mountain Clinical Research, LLC — Englewood, Colorado, United States
• Georgetown University; Research Division, Psychiatry — Washington D.C., District of Columbia, United States
• University of South Florida — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• John Hopkins University School of Medicine — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Dent Neurological Institute — Amherst, New York, United States
• Columbia University — New York, New York, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• The University of Texas Health Science Center at Houston; McGovern Medical School — Houston, Texas, United States
• University of Utah Clinical Neurosciences Center — Salt Lake City, Utah, United States
• Evergreen Health Care Center — Kirkland, Washington, United States
• Hospital Ramos Mejía — CABA, Argentina
• INEBA — Capital Federal, Argentina
• Hospital Britanico de Buenos Aires — Ciudad Autonoma Buenos Aires, Argentina
• WESTMEAD HOSPITAL; Deparment of Neurology — Westmead, New South Wales, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• Uab Medicine — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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