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

Study acronym: HUNTIAM
StatusRecruiting
PhasePhase 2
Started2023-04-12
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 25, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-02-24
Study Status v10
Re-verified, no change to tracked fields
2024-06-04
Study Status, Contacts/Locations v9
Study sites2→3
2023-11-14
Study Status, Contacts/Locations v8
Study sitescontacts updated at 1 of 2 sites
2023-05-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v7
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-01-01→2025-06-30
Completion date2023-06-01→2025-12-30
Start dateestimated 2022-06-01→confirmed 2023-04-12
Study sites1→2
2022-05-23
Study Status v6
Start date2022-05-01→2022-06-01
Show 5 earlier versions
2022-03-31
Study Status v5
Start date2022-01-01→2022-05-01
2021-10-26
Study Status, Study Description, Outcome Measures, Eligibility v4
Eligibility criteria+267 characters
[...] and genetic confirmation of a number of repetitions of the cytokinecytosine-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 [...] accept the use of contraceptive methods Exclusion Criteria: DependentMedical patientscomorbidities forconsidered clinically significant by the clinical judgment of the investigators. Pregnancy or lactation Patients with HD dependents on the basic activities [...] [...]
Secondary endpoints6 to 1 entries
Efficacy of treatment due to increased levels of NfL in neurodegeneration produced in HD Measurement of quality of life. Short Form Health Survey (SF-36) Measurement of bradykinesia Measurement of bradykinesia through quantitative movement measurement techniques Quantitative movement measurement tec [...]
Study description+786 characters
[...] d consent until the end the follow up. The evaluation of the biological efficacy of treatment with combined oral thiamine and bioti [...] herapy in increasing thiamine monophosphate (TMP) levels in cerebrospinal fluid (CSF) of patients with HD is to be performed by: The determination of thiamine levels: free thiamine, TMP, and thiamine pyrophosphate (TTP) in cerebrospinal fluid (CSF) and blood of patients at the beginning and after the end of itthe study. Comparison of thiamine levels (free, TMP and TTP) between the start and the end of the study in CSF and serum of patients with HD. The evaluation o [...] [...]
2021-10-14
Study Status v3
Primary completion date2022-04-01→2023-01-01
Completion date2022-08-01→2023-06-01
Start date2021-04-01→2022-01-01
2021-01-21
Study Status v2
Primary completion date2022-01-01→2022-04-01
Completion date2022-06-01→2022-08-01
Start date2021-01-01→2021-04-01
2020-12-09
Study Status, Study Description, Outcome Measures, Eligibility v1
Primary completion date2021-10-01→2022-01-01
Completion date2021-12-01→2022-06-01
Start date2020-10-01→2021-01-01
Eligibility criteria+41 characters
[...] 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 3 [...]
Secondary endpoints6 entries, revised
Measurement of quality of life. Short Form Health Survey (SF-36)
Study description+35 characters
[...] lysis will be carried out using the statistical program IBM Statistical Package for the Social Sciences (SPSS Statistics) v.24.0. Linear regression will be used when the variables a [...]
2020-07-15
Original filing
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
Trial Details
NCT Number NCT04478734
Lead Sponsor Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators: Consorcio Centro de Investigación Biomédica en Red (CIBER)
Conditions Huntington Disease
Enrollment 24 participants
Start Date 2023-04-12
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-25