Status:
RECRUITING
Trial of the Combined Use of Thiamine and Biotin in Patients With Huntington's Disease
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborating Sponsors:
Ciberned (Centro de Investigación Biomédica en Red)
Conditions:
Huntington Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
The assessment of the safety and tolerability of the combined oral thiamine and biotin therapy in patients with HD will be performed by: * Periodic clinical examination and anamnesis directed by a ne...
Eligibility Criteria
Inclusion
- Patients of legal age with manifest Huntington's disease with motor symptoms (chorea, dystonia or bradykinesia) and/or neuropsychiatric; and genetic confirmation of a number of repetitions of the cytosine-adenine-guanine trinucleotide (CAG triplet) in the HTT gene (coding for HTT) greater than or equal to 39
- Patients should be capable of giving informed consent and attending the planned visit of the study.
- Women of childbearing age should obtain a negative result in the serum or urine pregnancy test at the screening visit. They must also accept the use of appropriate contraceptive methods during the course of the clinical trial and men who have a partner of childbearing age, accept the use of contraceptive methods
Exclusion
- Medical comorbidities considered clinically significant by the clinical judgment of the investigators.
- Pregnancy or lactation
- Patients with HD dependents on the basic routine daily life activities (UHDRS TFC \< 7) or a severe cognitive decline.
- Active psychosis at the moment of the screening evaluation.
- Severe renal failure.
- Patients previously treated with thiamine and/or biotin or enrolled in other HD clinical trial with oligonucleotide antisense (IONIS-HTTRX (RG6042).
Key Trial Info
Start Date :
April 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04478734
Start Date
April 12 2023
End Date
December 30 2025
Last Update
February 25 2025
Active Locations (3)
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1
Hospital Universitario de San Sebastián
San Sebastián, San Sebastian, Spain, 20014
2
Virgen del Rocío Hospital
Seville, Seville, Spain, 41013
3
Hospital Ramón y Cajal
Madrid, Spain