Phase 2 Huntington's Disease Trial, Recruiting NCT05509153 Sponsor: Western Sydney Local Health District Condition: Huntington's Disease
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Phase 2 Huntington's Disease Trial, Recruiting

NCT05509153
Recruiting Phase 2 🇦🇺 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 are able to give your informed consent to take part in the study
  • You carry an expanded Huntingtin gene with 39 or more CAG repeats (a genetic marker linked to Huntington's disease)
  • You do not yet have clear physical/movement symptoms of Huntington's disease, based on a standard assessment called the UHDRS
  • Based on this same assessment, your diagnostic confidence level is below 4 at the time of joining (confirm with trial site)
  • Based on a specific calculation called the Langbehn formula, you are expected to develop clinical Huntington's disease within the next 10 years
  • You have a family member, friend, or carer who can provide background information about you to the research team
  • If you are a woman who could become pregnant, you have a negative pregnancy blood test before joining
  • If you could become pregnant, you agree to either abstain from sex or use reliable contraception throughout the study
  • You are able to tolerate MRI scans
  • You are able to tolerate having blood samples taken
  • You are able to follow all the requirements of the study, in the opinion of the research team
  • You are considered medically, mentally, and neurologically stable at the time of joining, in the opinion of the research team

Who may not be able to join:

  • You have already been diagnosed with clinical Huntington's disease
  • You have a known allergy or sensitivity to NAC (N-acetylcysteine)
  • You are currently pregnant, breastfeeding, or plan to become pregnant or breastfeed before the study ends
  • You have taken part in another clinical trial and received an experimental drug within the 30 days before your first study visit
  • You are currently taking NAC as a supplement
  • You have abnormal results from blood tests, a heart tracing (ECG), or vital signs at your screening appointment that could make it unsafe for you to take part
  • You currently have, or have had within the past year, a problem with substance or alcohol misuse
  • You have an unstable mental health condition or a serious active medical illness, including cancer, as judged by the research team
  • You are currently taking antipsychotic medications or a drug called Tetrabenazine
  • You have previously had gene therapy, a cell transplant, or any experimental brain surgery
  • You have had thoughts of suicide or a suicide attempt within the 12 months before your screening appointment
  • An MRI scan taken during screening shows a pre-existing structural problem in your brain

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: Clement Loy, University of Sydney

Phone: 001164 4 8890 3560

Australian sites

Westmead Hospital, Westmead, New South Wales
The University of Queensland, Herston, Queensland
Calvary Health Care Bethlehem, Parkdale, Victoria
The Royal Melbourne Hospital, Parkville, Victoria
Perron Institute, Nedlands, Western Australia

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
Sponsor
Western Sydney Local Health District
Registry
ClinicalTrials.gov
Start date
1 June 2024
Est. completion
1 November 2026

Where this trial is recruiting

🇦🇺 Australia

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

Primary endpoints

Caudate Atrophy Rate on volumetric MRI; Rate of motor phenoconversion

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