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

NCT03761849

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Huntingtons Disease

Interventions: RO7234292, Placebo

Countries: United States, Argentina, Australia, Austria, Canada, Chile, Denmark, France

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

Eligibility overview

Sex: ALL

Age: 25 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 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
Locations (96)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • La Jolla, California, United States
  • Palo Alto, California, United States
  • Pasadena, California, United States
  • Sacramento, California, United States
  • Englewood, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Tampa, Florida, United States
  • Chicago, Illinois, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • Amherst, New York, United States
  • New York, New York, United States
  • Pittsburgh, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Kirkland, Washington, United States
  • CABA, Argentina
  • Capital Federal, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Westmead, New South Wales, Australia
  • Clayton, Victoria, Australia
  • Parkville, Victoria, Australia
  • Innsbruck, Austria
  • Salzburg, Austria
  • Edmonton, Alberta, Canada
  • Vancouver, British Columbia, Canada
  • + 66 more on CT.gov