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

NCT04478734 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-02-25

No results posted yet for this study

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

Conditions

  • Huntington Disease

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

Sponsors & Collaborators

  • Ciberned (Centro de Investigación Biomédica en Red)

    collaborator UNKNOWN

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Pablo Mir Rivera, MD/PhD · Institute of Biomedicine of Seville (IBiS)

  • Clara M. Rosso Fernández · Virgen del Rocío University Hospital Research and Clinical Trials Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2025-06-30
Completion
2025-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04478734 on ClinicalTrials.gov