Combined Thiamine and Biotin Treatment for Huntington's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the safety and tolerability of combined oral thiamine and biotin therapy in patients with mild to moderate Huntington's disease. The study aims to assess the biological effects of the treatment by measuring thiamine monophosphate levels in cerebrospinal fluid over a one-year follow-up period. Participants will undergo periodic clinical examinations and monitoring for adverse effects, alongside analytical assessments of thiamine levels in both cerebrospinal fluid and blood. The ultimate goal is to determine if this combination therapy can modify the disease course or slow symptom progression in early-stage Huntington's disease patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients of legal age with manifest Huntington's disease with motor symptoms (chorea, dystonia or bradykinesia) and/or neuropsychiatric; and genetic confirmation of a number of repetitions of the cytosine-adenine-guanine trinucleotide (CAG triplet) in the HTT gene (coding for HTT) greater than or equal to 39
* Patients should be capable of giving informed consent and attending the planned visit of the study.
* Women of childbearing age should obtain a negative result in the serum or urine pregnancy test at the screening visit. They must also accept the use of appropriate contraceptive methods during the course of the clinical trial and men who have a partner of childbearing age, accept the use of contraceptive methods

Exclusion Criteria:

* Medical comorbidities considered clinically significant by the clinical judgment of the investigators.
* Pregnancy or lactation
* Patients with HD dependents on the basic routine daily life activities (UHDRS TFC \< 7) or a severe cognitive decline.
* Active psychosis at the moment of the screening evaluation.
* Severe renal failure.
* Patients previously treated with thiamine and/or biotin or enrolled in other HD clinical trial with oligonucleotide antisense (IONIS-HTTRX (RG6042).

Where it's running

• Hospital Universitario de San Sebastián
  San Sebastián, San Sebastian, Spain Recruiting
• Virgen del Rocío Hospital
  Seville, Seville, Spain Recruiting
• Hospital Ramón y Cajal
  Madrid, Spain Recruiting

Study contacts

• Principal investigator: Clara M. Rosso Fernández — Virgen del Rocío University Hospital Research and Clinical Trials Unit
• Study coordinator: Pablo Mir Rivera, MD/PhD
• Email: pmir@us.es
• Phone: +34 955923039

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pridopidine for Huntington's Disease: a 1-year, randomized, placebo-controlled study

  This trial tests whether pridopidine can slow the progression of Huntington's disease in adults compared with placebo over one year.

  Recruiting at 17 sites Phase 3 Prilenia · Birmingham, Alabama and 65 other locations · NCT07609108

• Low-intensity focused ultrasound targeting the globus pallidus to improve movement in Huntington's disease

  This trial tests whether different pulse frequencies of low-intensity focused ultrasound (LIFU) aimed at a deep brain target can safely reduce chorea and other motor symptoms in adults with Huntington's disease.

  Recruiting First Affiliated Hospital of Fujian Medical University · Fuzhou, Fujian · NCT07513844

• Safety and tolerability of human neural stem cell implants for Huntington's disease

  This research will test whether an implant of hNSC-01 human neural stem cells is safe and tolerable for adults with Huntington's disease.

  Recruiting Phase 1/2 University of California, Irvine · Irvine, California · NCT07451613

• SKY-0515 for adults with Huntington's disease

  This trial will test whether the oral drug SKY-0515 can lower harmful huntingtin protein and improve symptoms in adults aged 25 and older with genetically confirmed Huntington's disease.

  Recruiting at 19 sites Phase 2/3 Skyhawk Therapeutics, Inc. · Englewood, Colorado and 30 other locations · NCT07378644

• Votoplam for adults with early symptomatic Huntington's disease

  This trial will test whether votoplam (HTT227) is safe and can slow disease progression in adults with early symptomatic Huntington's disease.

  Recruiting at 117 sites Phase 3 Novartis · Birmingham, Alabama and 116 other locations · NCT07326709

• Comparing three social cognition tests in adults with early Huntington disease

  This project will test whether the DMASC-MC and two established social cognition tests can detect social thinking problems in adults with early Huntington disease.

  Recruiting Region Skane · Lund · NCT07253038

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.