Phase 2 Huntington's Disease Trial, Recruiting NCT04478734 Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Condition: Huntington's Disease
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Phase 2 Huntington's Disease Trial, Recruiting

NCT04478734
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 must be a legal adult who has been diagnosed with Huntington's disease and is experiencing movement symptoms (such as involuntary movements, muscle stiffness, or slowness) and/or mental or emotional symptoms.
  • You must have had a genetic test confirming a specific change in the HTT gene (a CAG repeat count of 39 or more).
  • You must be able to understand and agree to participate in the study, and be able to attend the scheduled visits.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test at the start of the study and agree to use contraception throughout the trial.
  • If you are a man whose partner could become pregnant, you must agree to use contraception throughout the trial.

Who may not be able to join:

  • People who have other serious health conditions that the study doctors consider medically significant.
  • People who are pregnant or currently breastfeeding.
  • People whose Huntington's disease has progressed to the point where they need help with basic daily activities, or who have severe memory or thinking difficulties (confirm with trial site).
  • People who are currently experiencing active psychosis (such as hallucinations or delusions) at the time of screening.
  • People with severe kidney failure.
  • People who have previously been treated with thiamine and/or biotin, or who are enrolled in another Huntington's disease trial involving a specific type of drug called an antisense oligonucleotide (IONIS-HTTRX/RG6042).

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: Pablo Mir Rivera, MD/PhD, Institute of Biomedicine of Seville (IBiS)

Phone: +34 955923039

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
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Registry
ClinicalTrials.gov
Start date
12 April 2023
Est. completion
30 June 2025

Where this trial is recruiting

🇪🇸 Spain

Primary endpoints

Incidence of Treatment-Emergent Adverse Events as assessed by clinical examination anamnesis and Analytical monitoring with hematological and biochemical control (hepatic and renal function)

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