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Eine Studie zur Beurteilung der Wirksamkeit und Sicherheit von intrathekal verabreichtem RO7234292 (RG6042) bei Patient*innen mit manifester Chorea Huntington
A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease
- Neurodegenerative Erkrankung
- Huntington-Krankheit
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Städte
- Aachen
- Berlin
- Bochum
- Bonn
- Erlangen
- Lübeck
- Münster
- Ulm
Studien-ID:
NCT03761849 BN40423
Studienzusammenfassung
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
Studien-ID
RO7234292, Placebo
Treatments
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
Einschlusskriterien
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
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