RecruitingPhase 2NCT04478734

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

Multicentric Trial on the Use of Combined Therapy of Thiamine and Biotine in Patients With Huntington´s Disease


Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Enrollment

24 participants

Start Date

Apr 12, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called High doses of Thiamine y Biotin and a drug called Moderate doses of Thiamine y Biotin for people with huntington disease. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGModerate doses of Thiamine y Biotin

Thiamine 600 mg every day + Biotin 150mg every day

DRUGHigh 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

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NCT04478734


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