Trial on the use of thiamine and biotin in patients with Huntington's disease.

Phase 1

• Conditions: Huntington´s disease; MedDRA version: 20.0Level: PTClassification code 10070668Term: Huntington's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-004360-22-ES
• Lead Sponsor: Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas (Ciberned)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-10
• Last Update Posted: 3 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

. Patients with Huntington's disease manifest with motor symptoms (chorea, dystonia or bradykinesia) and / or neuropsychiatric; and genetic confirmation of a number of repetitions of the CAG triplet in the HTT gene.
. Patient older than or equal to 39 years
. Women of childbearing age must obtain a negative result in the pregnancy test at the selection visit and accept the use of appropriate contraceptive methods throughout the course of the clinical trial and men who have a partner in childbearing age, accept the use of methods contraceptives
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

. Dependent patients for ABVD or with a degree of severe cognitive impairment that prevents participation / follow-up in the study
(UHDRS TFC <7).
. Patients with active psychosis at the time of clinical evaluation.
. Pregnant or breastfeeding patients.
. Advanced renal failure.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified