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

MULTI-TECHNICAL TEST ON THE USE OF COMBINED THERAPY OF THEMIN AND BIOTINE IN PATIENTS WITH HUNTINGTON'S DISEASE - Huntiam

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004360-22-ES

Enrollment

Registered

2020-01-10

Start date

2021-10-22

Completion date

Unknown

Last updated

2021-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington´s disease MedDRA version: 20.0 Level: PT Classification code 10070668 Term: Huntington's disease System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Benerva Product Name: Benerva Pharmaceutical Form: Capsule Product Name: Biotina Pharmaceutical Form: Capsule INN or Proposed INN: BIOTIN CAS Number: 58-85-5 Other descriptive name: Vitam

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Safety and tolerability of combined oral thiamine with biotin therapy in patients with HD.;Secondary Objective: Demonstrate an increase in the level of thiamine monophosphate (TMP) in CSF of combined oral thiamine and biotin therapy in patients with HD;Primary end point(s): . Evaluate the safety and tolerability of combined oral thiamine with biotin therapy in patients with mild to moderate stages of HH through physical examinations and biochemical tests in blood and urine, in addition to the collection of adverse events.;Timepoint(s) of evaluation of this end point: . Blood count, biochemistry and coagulation: Week 0,2,4,6,8,12,24, 36,48 and 52. . Physical exams (Blood pressure, heart rate, weight, height): Week 0,2,4,6,8,12,24, 36,48 and 52 . Evaluation of the patient's quality of life and overall (SF36, CGI-S and CGI-C scale): Week 0, 24 and 48 . Evaluation of disease and motor function: screening and Baseline visit and week 8, 24,36 and 48	—

Measure

Time frame

Main Objective: Safety and tolerability of combined oral thiamine with biotin therapy in patients with HD.;Secondary Objective: Demonstrate an increase in the level of thiamine monophosphate (TMP) in CSF of combined oral thiamine and biotin therapy in patients with HD;Primary end point(s): . Evaluate the safety and tolerability of combined oral thiamine with biotin therapy in patients with mild to moderate stages of HH through physical examinations and biochemical tests in blood and urine, in addition to the collection of adverse events.;Timepoint(s) of evaluation of this end point: . Blood count, biochemistry and coagulation: Week 0,2,4,6,8,12,24, 36,48 and 52. . Physical exams (Blood pressure, heart rate, weight, height): Week 0,2,4,6,8,12,24, 36,48 and 52 . Evaluation of the patient's quality of life and overall (SF36, CGI-S and CGI-C scale): Week 0, 24 and 48 . Evaluation of disease and motor function: screening and Baseline visit and week 8, 24,36 and 48

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Secondary

Measure	Time frame
Secondary end point(s): . To evaluate the biological effect of the treatment on the central nervous system using as a main biomarker the increase in the level of thiamine monophosphate (TMP) in CSF of these patients with HD during a one-year follow-up period, by lumbar puncture for the determination of NfL and thiamine (free, TMP, TPP) in CSF and skull MRI;Timepoint(s) of evaluation of this end point: . MRI of the skull and lumbar puncture: week 0 (Baseline visit) and week 48 . Determination of thiamine (free, TMP, TPP) and plasma neurofilament light chain protein (NfL): Week 0 (visit Baseline), week 24 (visit 6), week 48 (visit 8) and week 52 (visit 9)	—

Measure

Time frame

Secondary end point(s): . To evaluate the biological effect of the treatment on the central nervous system using as a main biomarker the increase in the level of thiamine monophosphate (TMP) in CSF of these patients with HD during a one-year follow-up period, by lumbar puncture for the determination of NfL and thiamine (free, TMP, TPP) in CSF and skull MRI;Timepoint(s) of evaluation of this end point: . MRI of the skull and lumbar puncture: week 0 (Baseline visit) and week 48 . Determination of thiamine (free, TMP, TPP) and plasma neurofilament light chain protein (NfL): Week 0 (visit Baseline), week 24 (visit 6), week 48 (visit 8) and week 52 (visit 9)

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Countries

Spain

Contacts

Public ContactUICEC-HUVR

FISEVI- Unidad de Investigación clínica y de ensayos clínicos

claram.rosso.sspa@juntadeandalucia.es0034955013414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026