NCT04478734 · Phase 2 · RECRUITING
Trial of the Combined Use of Thiamine and Biotin in Patients With Huntington's Disease
This trial is testing whether a combination of two B vitamins, thiamine (B1) and biotin (B7), is safe and tolerable for people with early-to-moderate Huntington's disease. Researchers are also looking at whether the vitamins affect the central nervous system by measuring changes in spinal fluid. This is a Phase 2 trial, meaning it is testing whether the approach works and is safe, not yet proven or approved.
You may qualify if
- 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
You're excluded if
- 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).
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-02-25