Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Huntingtons Disease
Eligibility:
All Genders
25-65 years
Phase:
PHASE3
Brief Summary
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2022
Estimated Enrollment :
899 Patients enrolled
Trial Details
Trial ID
NCT03761849
Start Date
January 23 2019
End Date
March 24 2022
Last Update
March 1 2024
Active Locations (96)
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1
Uab Medicine
Birmingham, Alabama, United States, 35294
2
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
3
University of California San Diego
La Jolla, California, United States, 92037-1337
4
Stanford Univ Medical Center
Palo Alto, California, United States, 94304