Phase 3 Huntington's Disease Trial, Completed NCT03761849 Sponsor: Hoffmann-La Roche Condition: Huntington's Disease
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT03761849) involved people with Huntington's disease and tested a medicine called tovorafenib (also referred to as "Tomi") as well as an earlier investigational medicine called RO7234292, compared against placebo (a dummy treatment with no active ingredient). In total, 899 people were enrolled across six groups. Three of those groups — all receiving either RO7234292 or its placebo — did not complete the study as a group (0 completions recorded), while in the tovorafenib and its placebo groups, between 207 and 216 out of roughly 263–264 participants in each group completed the trial. The trial primarily measured changes in a combined Huntington's disease rating scale (called the cUHDRS, which bundles together scores for physical function, movement, and two thinking tasks into a single number) and a separate measure of day-to-day functioning called the Total Functional Capacity (TFC) score. The reported data shows that for the main combined rating scale (cUHDRS), scores changed from the starting point (baseline) as follows: the placebo group in the tovorafenib part of the trial showed a change of −0.630, the tovorafenib every-8-weeks group showed −0.793, and the tovorafenib every-16-weeks group showed −1.173. For context, the trial description notes that a worsening of 1.2 or more on this scale is considered a meaningful decline. For the TFC functioning score (where lower is worse), the reported changes from baseline were −0.883 for the placebo group, −0.921 for the tovorafenib every-16-weeks group, and −1.284 for the tovorafenib every-8-weeks group. Secondary measures — including motor (movement) scores, two thinking/cognitive tests, and a clinician-rated severity scale — were also reported across the groups, with changes in various directions across all groups; the full numbers for each group are recorded on ClinicalTrials.gov. For the clinician severity scale, data was only reported for the tovorafenib and its placebo groups, and was not available for the RO7234292 groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Huntington's Disease Trial, Completed

NCT03761849
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with manifest (confirmed, active) Huntington's Disease, based on a specific scoring system used by doctors (called a DCL score of 4)
  • You are largely independent in your daily life, scoring 70 or above on an Independence Scale used to measure how well someone can function on their own
  • Your Huntington's Disease has been confirmed through genetic (DNA) testing, with a specific genetic measurement (CAP score) above 400
  • A doctor has assessed that you are able to take care of yourself and carry out everyday activities on your own at the start of the trial

Who may not be able to join:

  • You have a serious medical condition, an important abnormality in lab test results or vital signs (such as blood pressure or heart rate), or a fear of enclosed spaces (claustrophobia) that the trial doctor believes would make it unsafe for you to participate
  • You are pregnant, breastfeeding, or planning to become pregnant during the trial or within 5 months after your last dose of the trial medication

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Australian sites

WESTMEAD HOSPITAL; Deparment of Neurology, Westmead, New South Wales
Monash Medical Centre, Clayton, Victoria
Royal Melbourne Hospital; Department of Neurology, Parkville, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
23 January 2019
Est. completion
24 March 2022

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇨🇦 Canada 🇨🇱 Chile 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇺 Russia 🇪🇸 Spain 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov