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Antisense Oligonucleotide

RO7234292 (RG6042) 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
Patients who were screened and eligible for the placebo-controlled Phase III Study BN40423 but could not be randomized prior to the close of Study BN40423 enrollment due to challenges relating to the COVID-19 pandemic
Clinical assessment to ensure individual has intact functional independence at baseline to maintain self-care and core activities of daily living (ADLs).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights

Study Summary

This trial will study the long-term effects of RO7234292 on people who have completed other studies on Huntington's disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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will have the opportunity to enroll in an open-label extension study Patients who were screened and eligible for the Phase III study BN40423 but could not be randomized prior to the close of enrollment due to challenges relating to the COVID-19 pandemic will have the opportunity to enroll in an open-label extension study.
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The text suggests that the individual should have functional independence in order to maintain self-care and core activities of daily living.
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People who have been in a previous study for the development of the drug RO7234292 (RG6042) sponsored by Roche or Genentech are allowed to join an extension study.
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or more, was seen in 5.6% of the study population 5.6 percent of the study population had a HD diagnosis, which is defined as having a DCL score of 4 or more.
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The text states that if an individual's Independence Scale (IS) score is >=70 then they are considered to be independent.
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A disease that has been confirmed genetically by direct DNA testing with a CAP score of >400.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years 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 Cognition, Using Montreal Cognitive Assessment (MoCA)
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Percentage of Participants With Treatment Emergent Adverse Events

Side effects data

From 2022 Phase 3 trial • 236 Patients • NCT03842969
24%
Fall
16%
Back pain
8%
Anxiety
7%
Syncope
7%
Contusion
7%
Insomnia
7%
Irritability
7%
Headache
7%
Procedural pain
6%
Diarrhoea
6%
Gait disturbance
5%
Balance disorder
5%
Urinary tract infection
5%
Fatigue
5%
Depression
5%
CSF protein increased
3%
Nasopharyngitis
3%
Arthralgia
3%
Haematoma
2%
Pleocytosis
2%
Depressed mood
2%
Fracture pain
2%
Post lumbar puncture syndrome
2%
Psychotic disorder
2%
Ataxia
1%
Vision blurred
1%
Musculoskeletal stiffness
1%
Sinus congestion
1%
Clavicle fracture
1%
Cyst
1%
Periorbital haematoma
1%
Craniocerebral injury
1%
Rhinitis allergic
1%
Onychomycosis
1%
Tinnitus
1%
Amnesia
1%
Tooth infection
1%
Dizziness
1%
Abscess limb
1%
Skin abrasion
1%
Injection site infection
1%
Post-traumatic headache
1%
Psoriatic arthropathy
1%
Memory impairment
1%
Dysarthria
1%
Cholecystitis
1%
Suicidal behaviour
1%
Suicidal ideation
1%
Decubitus ulcer
1%
COVID-19 pneumonia
1%
Eye contusion
1%
Spinal compression fracture
1%
Enthesopathy
1%
Exostosis
1%
Spinal osteoarthritis
1%
Cerebral ventricle dilatation
1%
Extensor plantar response
1%
Pigmentation disorder
1%
Gastrooesophageal reflux disease
1%
Vertebral foraminal stenosis
1%
Lymphoedema
1%
Parkinsonism
1%
Limb mass
1%
Chorea
1%
Vertebral osteophyte
1%
Breast cancer
1%
Skin laceration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tominersen 120 mg Q16W
Tominersen 120 mg Q8W
Tominersen 120mg Q4W

Trial Design

2Treatment groups
Experimental Treatment
Group I: RO7234292 (RG6042) Q8WExperimental Treatment1 Intervention
Participants who received open-label RO7234292 Q4W in a preceding study or who received RO7234292 Q4W in this study may be randomly allocated to receive RO7234292 Q8W. Participants who previously received open-label of RO7234292 Q8W in a preceding study or are currently receiving RO7234292 Q8W in this study will receive RO7234292 Q8W. Participants who previously received placebo, or did not previously receive treatment with RO7234292 or received short-term treatment with a treatment-free follow-up period may be randomly allocated to receive RO7234292 Q8W. Participants who previously received blinded placebo Q8W may receive RO7234292 Q8W. Participants who received blinded RO7234292 Q8W will receive open-label RO7234929 Q8W. Participants who received blinded placebo Q8W may receive RO7234292 Q8W. Participants who received blinded RO7234292 Q4W or blinded placebo Q4W may be randomly allocated to receive open-label of RO7234292 Q8W.
Group II: RO7234292 (RG6042) Q16WExperimental Treatment1 Intervention
Participants who previously received open-label RO7234292 Q4W in a preceding study or who received RO7234292 Q4W in this study may be randomly allocated to receive RO7234292 Q16W. Participants who previously received placebo in a preceding study or did not previously receive treatment with RO7234292 or received short-term treatment with a treatment-free follow-up period may be randomly allocated to receive RO7234292 Q16W. Participants who previously received blinded placebo Q8W will receive RO7234292 Q8W. Participants who previously received blinded RO7234292 Q16W will receive open-label RO7234292 Q16W. Participants who received blinded RO7234292 Q4W or blinded placebo Q4W may be randomly allocated to receive open-label of RO7234292 Q16W. Participants who previously received open-label RO7234292 Q16W will receive open-label RO7234292 Q16W.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO7234292 (RG6042)
2019
Completed Phase 3
~300

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,088,814 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,242 Total Patients Enrolled

Frequently Asked Questions

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

What have been the most commonly reported side effects of RO7234292 (RG6042)?

"RO7234292 (RG6042) has received a score of 3 for safety. This is because Phase 3 trials have shown some efficacy and multiple rounds of data support the drug's safety."

Answered by AI

How many different settings are included in this trial?

"Patients are being accepted at a number of locations, these include but are not limited to: Ottawa Hospital Research Institute in Ottawa, Ontario; CenExel Rocky Mountain Clinical Research, LLC in Englewood, Colorado; and University of British Columbia Hospital; Division of Neurology in Vancouver, British Columbia."

Answered by AI

Are patients currently being accepted for this trial?

"Unfortunately, this particular clinical trial is not recruiting patients at the moment. Although the last update was on October 27th, 2022, the initial posting was on April 23rd, 2019. Having said that, there are 37 other trials that are presently looking for candidates."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
How old are they?
18 - 65
What site did they apply to?
CenExel Rocky Mountain Clinical Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria
~40 spots leftby Mar 2025