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)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Countries
  • Argentina
  • Australia
  • Austria
  • Canada
  • Chile
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Poland
  • Russia
  • Spain
  • Switzerland
  • United Kingdom
  • United States
Study Identifier:

NCT03761849 2018-002987-14 BN40423

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

      Results Disclaimer

      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)

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT03761849, BN40423, 2018-002987-14 Study 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

       

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