Multicentric trial on the use of combined therapy of Thiamine and biotine in patients with Huntington´s disease.

Phase 1

• Conditions: Huntington´s disease.; MedDRA version: 20.0Level: PTClassification code: 10070668Term: Huntington's disease Class: 100000004850; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-508637-14-00
• Lead Sponsor: Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Adult patients with Huntington's disease manifested by motor symptoms (chorea, dystonia or bradykinesia) and/or neuropsychiatric symptoms; and genetic confirmation of a number of repetitions of the CAG triplet in the HTT gene (coding for HTT) greater than or equal to 39 repetitions., Women of childbearing age must have a negative serum or urine pregnancy test result at the screening visit. Likewise, they must accept the use of adequate contraceptive methods at least 15 days prior to the screening visit, during the course of the clinical trial and at least 15 days after the last visit., In men who have a partner of childbearing age, accept the use of contraceptive methods., Ability to give informed consent and comply with the visits stipulated in the study.

Exclusion Criteria

Clinically significant medical problems that, in the judgment of the investigators, may cause tissue damage to the CNS or limit its repair, or that may expose the patient to unjustified risk or harm, or cause the patient not to complete the study., Pregnancy or breastfeeding, or planning to become pregnant or patients of childbearing age not undergoing birth control methods (recommended by the Clinical Trial Facilitation Group (CTFG): http://www.hma.eu/fileadmin/dateien/Human_Medicines/ 01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf)., Patients dependent on basic activities of daily living (ABDL) or with a degree of severe cognitive impairment that prevents participation/follow-up in the study (UHDRS, Unified Huntington Disease Rating Scale TFC < 7)., Patients with active psychosis at the time of clinical evaluation., Advanced kidney failure.

Study & Design

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