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

Condition(s) studied

Investigational drug(s) / intervention(s)

Moderate doses of Thiamine y Biotin: Thiamine 600 mg every day + Biotin 150mg every day

High doses of Thiamine y Biotin: Thiamine 1200 mg every day + Biotin 300mg every day

Study 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 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

Eligibility

Primary outcome measure(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) — From signature of informed consent form, at all scheduled visits, to end of follow up week 52
  Patient´s condition and emergence of comorbidity by clinical examination and anamnesis directed by a neurologist, by measuring of vital signs (blood pressure, heart rate,breath rate weight and height)

Trial sites (3)

More Fundación Pública Andaluza para la gestión de la Investigación en Sevilla trials in Spain

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