NCT04478734RecruitingPhase 2
Trial of the Combined Use of Thiamine and Biotin in Patients With Huntington's Disease
Multicentric Trial on the Use of Combined Therapy of Thiamine and Biotine in Patients With Huntington´s Disease
Source: ClinicalTrials.gov · Last updated 25 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 11 Feb 2020
- Start date
- 12 Apr 2023
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Diseases
- Huntington's disease
- NCT number
- NCT04478734
- EU CT number
- 2023-508637-14-00
- EudraCT number
- 2019-004360-22
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 24
- From 12 Apr 2023 to the primary completion date, 30 Jun 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously treated with thiamine and/or biotin or enrolled in other HD clinical trial with oligonucleotide antisense (IONIS-HTTRX (RG6042).
Other illness
- Severe renal failure.
Other
- Medical comorbidities considered clinically significant by the clinical judgment of the investigators.
- Pregnancy or lactation
- Patients with HD dependents on the basic routine daily life activities (UHDRS TFC \< 7) or a severe cognitive decline.
- Active psychosis at the moment of the screening evaluation.
Who the study is looking for
- Patients of legal age with manifest Huntington's disease with motor symptoms (chorea, dystonia or bradykinesia) and/or neuropsychiatric; and genetic confirmation of a number of repetitions of the cytosine-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 the serum or urine pregnancy test at the screening visit. They must also accept the use of appropriate contraceptive methods during the course of the clinical trial and men who have a partner of childbearing age, accept the use of contraceptive methods
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Recruiting |
| Hospital Universitario Virgen del Rocío Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Ramón y Cajal (Madrid, SPAIN) Coordinator of this site? Confirm its status | - | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.