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RO7234292 for Huntington's Disease

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for odc at 13th month, for ndc at week 101
Awards & highlights

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)

Eligible Conditions
  • Huntington's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for odc at 13th month, for ndc at week 101
This trial's timeline: 3 weeks for screening, Varies for treatment, and for odc at 13th month, for ndc at week 101 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the Composite Unified Huntington's Disease Rating Scale (cUHDRS) Score-Z Score
Change From Baseline in the Total Functional Capacity (TFC) Score
Secondary outcome measures
Change From Baseline in CSF Neurofilament Light Chain (NfL) Proteint Level
Change From Baseline in CSF mHTT Protein Level
Change From Baseline in Montreal Cognitive Assessment (MoCA)
+14 more

Side effects data

From 2022 Phase 3 trial • 899 Patients • NCT03761849
19%
Post lumbar puncture syndrome
14%
Procedural pain
11%
Headache
11%
Back pain
11%
Fall
6%
Urinary tract infection
6%
Diarrhoea
6%
Puncture site pain
6%
Paraesthesia
6%
Haematoma
6%
Vomiting
6%
Contusion
6%
Somnolence
6%
Pain in extremity
3%
Insomnia
3%
Anxiety
3%
Gait disturbance
3%
Pyrexia
3%
Suicidal ideation
3%
Nasopharyngitis
3%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Q8W ODC
Q8W NDC
Q4W ODC
PLB NDC
PLB ODC
Q16W NDC

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: RO7234292 Q8WExperimental Treatment1 Intervention
RO4234292 is administered intrathecally every 8 weeks.
Group II: RO7234292 Q16WExperimental Treatment2 Interventions
RO7234292 is administered intrathecally every 16 weeks. Participants in this arm will also receive placebo at alternate weeks to keep the blind.
Group III: PlaceboPlacebo Group1 Intervention
Placebo will be administered every 8 weeks by IT injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
RO7234292
2019
Completed Phase 3
~900

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,166 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
887,546 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
University of British Columbia Hospital; Division of Neurology
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease
2019. "A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03761849.
~146 spots leftby Apr 2025
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