Clinical Trial

Trial of the Combined Use of Thiamine and Biotin in Patients With Huntington's Disease

Study acronym: HUNTIAM
Recruiting Phase 2
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Record status
This record was last updated February 25, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2020-07-15; most recent amendment 2025-02-24.
Status change: Not Yet Recruiting → Recruiting 2023-05-03
Trial Details
NCT Number NCT04478734
Lead Sponsor Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators: Consorcio Centro de Investigación Biomédica en Red (CIBER)
Conditions Huntington Disease
Enrollment 24 participants
Start Date 2023-04-12
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-25