drugset / Trial / NCT04478734
Trial of the Combined Use of Thiamine and Biotin in Patients With Huntington's Disease
Phase 2
Recruiting
24 enrolled
Andalusian Public Foundation for Health Research in Seville
Consorcio Centro de Investigación Biomédica en Red (CIBER) · collab
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2023-04-12
- Primary completion
- 2025-06-30
- Completion
- 2025-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Biotin | Small molecule | 150 mg | Oral |
| Subject | Biotin | Small molecule | 300 mg | Oral |
| Subject | Thiamine | Other / unclassified | 600 mg | Oral |
| Subject | Thiamine | Other / unclassified | 1200 mg | Oral |