Phase 2 Huntington's Disease Trial, Recruiting NCT06826612 Sponsor: Hoffmann-La Roche Condition: Huntington's Disease
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Phase 2 Huntington's Disease Trial, Recruiting

NCT06826612
Recruiting Phase 2

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:

  • Genetic testing (confirmed by the trial's central laboratory) shows a specific mutation in the huntingtin gene — a CAG repeat length of 40 or more.
  • Brain scans show a certain level of shrinkage in a part of the brain called the striatum (caudate), based on age-related measurements linked to an early stage of Huntington's disease.
  • A standard Huntington's disease movement assessment (called the Total Motor Score) meets or exceeds a certain age-related threshold linked to a specific stage of the disease.
  • A measure of daily functioning (called Total Functional Capacity) scores 11 or higher, indicating a relatively high level of independence.
  • If taking certain brain or nerve medications (such as cholinesterase inhibitors, memantine, amantadine, or riluzole), the dose must have been stable for at least 12 weeks before joining and is expected to stay the same for the first 12 months of the trial.
  • If taking antidepressants or benzodiazepines, the dose must have been stable for at least 12 weeks before joining and is expected to remain unchanged for the first 12 months of the trial.
  • If taking antipsychotics or certain movement-control medications (such as tetrabenazine or similar drugs), the dose must have been stable for at least 12 weeks before joining and is expected to stay the same for the first 12 months of the trial.

Who may not be able to join:

  • Brain scans show that it would not be safe to place the treatment device into the required brain areas on both sides of the brain, due to the extent of brain shrinkage or other physical features (confirm with trial site).
  • Has received a type of treatment called antisense oligonucleotide therapy within the past year.
  • Has previously had deep brain stimulation surgery.
  • Has previously had, or plans to have, gene therapy, a cell transplant, or any brain surgery during the course of the study.
  • Has taken part in another clinical drug trial with a treatment given throughout the body within the past 6 weeks (or longer, depending on how long the drug stays in the body).

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 2: approximately ~30% 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-LaRoche

Phone: 888-662-6728

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

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
21 February 2025
Est. completion
12 January 2035

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Participants with Treatment-emergent Adverse Events (TEAEs); Severity of TEAEs; Change from Baseline in Unified Huntington's Disease Rating Scale (UHDRS®) 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