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RECRUITING
NCT04478734
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Moderate doses of Thiamine y Biotin

Thiamine 600 mg every day + Biotin 150mg every day

DRUG

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