Actively Recruiting
Trial of the Combined Use of Thiamine and Biotin in Patients With Huntington's Disease
Led by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Updated on 2025-02-25
24
Participants Needed
3
Research Sites
141 weeks
Total Duration
On this page
Sponsors
F
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead Sponsor
C
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Evaluate the safety and tolerability of combined oral thiamine with biotin therapy in patients with Huntington´s disease in mild to moderate stages and it is intended to evaluate the biological effect of the treatment in the central nervous system of these patients using as the main biomarker the increase in the level of thiamine monophosphate (TMP) in cerebrospinal fluid (CSF) of these patients with Huntington Disease (HD) during a follow-up period of one year. Our main hypothesis is that combined thiamine-biotin oral therapy is a secure and well-tolerated treatment, potentially capable of modifying the disease course or avoiding the progression of symptoms in early-stages HD patients
CONDITIONS
Official Title
Trial of the Combined Use of Thiamine and Biotin in Patients With Huntington's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older with manifest Huntington's disease showing motor or neuropsychiatric symptoms
- Genetic confirmation of CAG triplet repeats in the HTT gene greater than or equal to 39
- Ability to provide informed consent and attend study visits
- Women of childbearing age must have a negative pregnancy test and agree to use contraception; men with partners of childbearing age must also agree to use contraception
You will not qualify if you...
- Significant medical conditions judged by investigators
- Pregnancy or breastfeeding
- Dependence on basic daily activities (UHDRS TFC less than 7) or severe cognitive decline
- Active psychosis at screening
- Severe kidney failure
- Prior treatment with thiamine or biotin or participation in other HD clinical trials with oligonucleotide antisense
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hospital Universitario de San Sebastián
San Sebastián, San Sebastian, Spain, 20014
Actively Recruiting
2
Virgen del Rocío Hospital
Seville, Seville, Spain, 41013
Actively Recruiting
3
Hospital Ramón y Cajal
Madrid, Spain
Actively Recruiting
Research Team
P
Pablo Mir Rivera, MD/PhD
CONTACT
C
Clara M. Rosso Fernández, MD/PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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