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

Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study ID
NCT04478734
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Moderate doses of Thiamine y Biotin — DRUG
    Thiamine 600 mg every day + Biotin 150mg every day
  • High doses of Thiamine y Biotin — DRUG
    Thiamine 1200 mg every day + Biotin 300mg every day

Study Details

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

Key Dates

First listed
Jul 21, 2020
Start date
Apr 12, 2023
Status verified
Jan 2025
Primary completion
Jun 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Moderate doses
    moderate doses of combination therapy applying the minimum average dosage of thiamine and biotin used in patients with BTBGD
  • Experimental: High doses
    high doses of the combination therapy applying the average standard dosage of thiamine and biotin used in patients with BTBGD.

Primary Outcome Measure

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 ]

Central Contacts

Find similar trials

Nationwide
Huntington disease trialsNeurology trialsBrain disorders trials

Related Studies