Phase 2 Huntington's Disease Trial, Recruiting NCT06853743 Sponsor: Oslo University Hospital Condition: Huntington's Disease
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Phase 2 Huntington's Disease Trial, Recruiting

NCT06853743
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:

  • You have been confirmed through genetic testing to carry the Huntington's disease (HD) gene, with a result showing 36 or more CAG repeats in the HTT gene.
  • You have been diagnosed with HD and show clear signs of the disease on a standard neurological examination.
  • Your HD is in an early or middle stage (Shoulson-Fahn stage 1–3) and you still have some level of daily functioning (TFC score above 2).
  • You are able to walk indoors on your own or with the help of a walking aid (such as a cane or walker).
  • You are able to write and complete pen-and-paper tests and questionnaires included in the study.
  • You are able to attend study visits (on your own or with help from a family member, friend, or carer) and take part in scheduled phone calls.
  • You are comfortable having blood drawn.
  • If you are a woman who could become pregnant, you are willing to use a highly effective form of birth control throughout the study.
  • You are able to understand the study and give your own signed consent to take part.

Who may not be able to join:

  • You have another significant neurological or psychiatric condition, such as a psychotic disorder, brain tumour, or inflammatory brain disease.
  • You have attempted suicide or had active thoughts of suicide within the past 12 months.
  • You have had a problem with alcohol or drug misuse or dependence (not including tobacco) in the 12 months before the start of the study.
  • You have had cancer in the past 5 years (except for certain successfully treated minor skin cancers or a specific type of cervical pre-cancer), or you had cancer more than 5 years ago that still carries a meaningful risk of coming back.
  • You have been diagnosed with significant heart disease (coronary artery disease) or significant blood vessel disease affecting the brain.
  • You have a high cardiovascular (heart and circulation) risk based on a specific risk assessment tool that takes into account factors like smoking, blood pressure, cholesterol, and family history (confirm with trial site).
  • You have any other medical condition that the study doctor believes could make it unsafe for you to participate or could affect the study results.
  • You have taken any form of vitamin B3 (niacin) supplements within the past 3 months or plan to take them during the study.
  • You have a major surgery planned during the study period that could affect your physical or mental assessments (for example, joint replacement or spinal surgery).
  • You have received or are receiving electroconvulsive therapy (ECT).
  • You are taking a medication with known serious side effects that the study doctor believes could affect your safety or the study results.
  • You have previously received any gene therapy for the treatment of HD.

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: Lasse Pihlstrøm, PhD, Oslo University Hospital

Phone: +47 95143795

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
18 March 2025
Est. completion
1 March 2029

Where this trial is recruiting

🇳🇴 Norway

Primary endpoints

Change from Baseline in the composite Unified Huntington's Disease Rating Scale at 730 days

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