A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients 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

Neurodegenerative Disorder
Huntington Disease (HD)

For Medical Professional
Results
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 3

Study Identifier NCT03761849, BN40423, 2018-002987-14

Condition Huntingtons Disease, Huntingtons Disease

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

Study 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

Gender

All

Age

≥25 Years & ≤ 65 Years

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

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

LPS BN40423 GENERATION HD1 Final Results September 2023 English (PDF, 1.2 MB)

LPS BN40423 GENERATION HD1 Final Results July 2023 Russia Russian (PDF, 0.7 MB)

LPS BN40423 GENERATION HD1 Final Results November 2023 France French (PDF, 1.7 MB)

LPS BN40423 GENERATION HD1 Final Results November 2023 Japan Japanese (PDF, 1.8 MB)

LPS BN40423 GENERATION HD1 Final Results September 2023 Argentina Spanish (PDF, 1.4 MB)

LPS BN40423 GENERATION HD1 Final Results September 2023 Austria German (PDF, 2.0 MB)

LPS BN40423 GENERATION HD1 Final Results September 2023 Chile Spanish (PDF, 1.2 MB)

LPS BN40423 GENERATION HD1 Final Results September 2023 Germany German (PDF, 1.3 MB)

LPS BN40423 GENERATION HD1 Final Results September 2023 Italy Italian (PDF, 1.1 MB)

LPS BN40423 GENERATION HD1 Final Results September 2023 Netherlands Dutch (PDF, 1.0 MB)

LPS BN40423 GENERATION HD1 Final Results September 2023 Poland Polish (PDF, 1.1 MB)

LPS BN40423 GENERATION HD1 Final Results September 2023 Spain Spanish (PDF, 1.1 MB)

LPS BN40423 GENERATION HD1 Final Results September 2023 Switzerland French (PDF, 1.8 MB)

LPS BN40423 GENERATION HD1 Final Results September 2023 Denmark Danish (PDF, 1.2 MB)

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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

For the latest version of this information please go to www.forpatients.roche.com