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

NCT03761849 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 899

Last updated 2024-03-01

Study results available
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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)

Conditions

  • Huntingtons Disease

Interventions

DRUG

RO7234292

Intrathecal injection

DRUG

Placebo

Intrathecal injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-23
Primary Completion
2022-03-24
Completion
2022-03-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Canada
  • Chile
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Poland
  • Russia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03761849 on ClinicalTrials.gov