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A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's Disease
- Neurodegenerative Disorder
- Huntington Disease (HD)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Cities
- Aachen
- Aarhus
- Aberdeen
- Amherst
- Angers
- Auckland
- Badajoz
- Baltimore
- Barakaldo
- Barcelona
- Basel
- Berlin
- Bern
- Birmingham
- Bologna
- Boston
- Buenos Aires
- Burgos
- Cambridge
- Cardiff
- Chicago
- Christchurch
- Clayton
- Créteil
- Denver
- Edmonton
- Erlangen
- Gdańsk
- Genova
- Glasgow
- Groningen
- Halifax
- Houston
- Innsbruck
- Kazan
- Kirkland
- Kodaira
- Kraków
- Krasnoyarsk
- København
- Lazio
- Leeds
- Leiden
- Lille
- London
- Lübeck
- Madrid
- Manchester
- Marseille
- Milano
- Montpellier
- Montréal
- Moscow Oblast
- Münster
- Nashville
- New York
- Osaka
- Ottawa
- Oxford
- Palo Alto
- Paris
- Parkville
- Pasadena
- Phoenix
- Pittsburgh
- Sacramento
- Salt Lake City
- Salzburg
- San Diego
- San Giovanni Rotondo
- Sevilla
- Sheffield
- Southampton
- St. Louis
- Tampa
- Toronto
- Toulouse
- Ulm
- València
- Vancouver
- Warszawa
- Washington
- Wellington
- Westmead
- 横浜市
Trial Identifier:
NCT03761849 GENERATION HD1 BN40423
Trial 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)
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT03761849, BN40423, GENERATION HD1
Trial Identifier
RO7234292, Placebo
Treatments
Huntingtons Disease, Huntingtons Disease
Condition
Official Title
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
Eligibility Criteria
All
Gender
≥25 Years & ≤ 65 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com