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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 1 February 2021
Main ID:  NCT04478734
Date of registration: 11/02/2020
Prospective Registration: Yes
Primary sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Public title: Trial of the Combined Use of Thiamine and Biotin in Patients With Huntington's Disease HUNTIAM
Scientific title: Multicentric Trial on the Use of Combined Therapy of Thiamine and Biotine in Patients With Huntington´s Disease
Date of first enrolment: April 1, 2021
Target sample size: 24
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT04478734
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Spain
Contacts
Name:     Clara M Rosso Fernández, MD/PhD
Address: 
Telephone: +34 955012144
Email: claram.rosso.sspa@juntadeandalucia.es
Affiliation: 
Name:     Pablo Mir Rivera, MD/PhD
Address: 
Telephone: +34 955923039
Email: pmir@us.es
Affiliation: 
Name:     Pablo Mir Rivera, MD/PhD
Address: 
Telephone:
Email:
Affiliation:  Institute of Biomedicine of Seville (IBiS)
Name:     Clara M. Rosso Fernández
Address: 
Telephone:
Email:
Affiliation:  Virgen del Rocío University Hospital Research and Clinical Trials Unit
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 cytokine-adenine-guanine trinucleotide (CAG triplet) in
the HTT gene (coding for HTT) greater than or equal to 39

- 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 Criteria:

- Dependent patients for basic activities of daily life (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-grade renal failure



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Huntington Disease
Intervention(s)
Drug: High doses of Thiamine y Biotin
Drug: Moderate doses of Thiamine y Biotin
Primary Outcome(s)
Incidence of Treatment-Emergent Adverse Events as assessed by clinical examination anamnesis and Analytical monitoring with hematological and biochemical control (hepatic and renal function) [Time Frame: From signature of informed consent form, at all scheduled visits, to end of follow up week 52]
Secondary Outcome(s)
Efficacy of treatment due to increased levels of NfL in neurodegeneration produced in HD [Time Frame: At baseline (week 0), week 24, week 48 and week 52]
Measurement of bradykinesia [Time Frame: At baseline (week 0), week 24 and week 48]
Measurement of bradykinesia through quantitative movement measurement techniques [Time Frame: At baseline (week 0), week 24 and week 48]
Measurement of quality of life. Short Form Health Survey (SF-36) [Time Frame: At baseline (week 0), week 24 and week 48]
Quantitative movement measurement techniques and evaluate change in bradykinesia [Time Frame: At baseline (week 0), week 24 and week 48]
The evaluation of the efficacy of treatment with combined oral thiamine and biotin therapy in increasing thiamine monophosphate (TMP) levels in CSF of patients with HD [Time Frame: At baseline (week 0) and visit 8 (week 48)]
Secondary ID(s)
HUNTIAM
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ciberned (Centro de Investigación Biomédica en Red)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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