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Trial of the Combined Use of Thiamine and Biotin in Patients With Huntington's Disease
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Summary
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
Official title: Multicentric Trial on the Use of Combined Therapy of Thiamine and Biotine in Patients With Huntington´s Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2023-04-12
Completion Date
2025-12-30
Last Updated
2025-02-25
Healthy Volunteers
No
Conditions
Interventions
Moderate doses of Thiamine y Biotin
Thiamine 600 mg every day + Biotin 150mg every day
High doses of Thiamine y Biotin
Thiamine 1200 mg every day + Biotin 300mg every day
Locations (3)
Hospital Universitario de San Sebastián
San Sebastián, San Sebastian, Spain
Virgen del Rocío Hospital
Seville, Seville, Spain
Hospital Ramón y Cajal
Madrid, Spain