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Multicentric trial on the use of combined therapy of Thiamine and biotine in patients with Huntington´s disease.
EU CTIS ID: 2023-508637-14-00
What this study is testing
To evaluate the safety and tolerability of oral combination therapy of thiamine with biotin in patients with HD.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients with Huntington's disease manifested by motor symptoms (chorea, dystonia or bradykinesia) and/or neuropsychiatric symptoms; and genetic confirmation of a number of repetitions of the CAG triplet in the HTT gene (coding for HTT) greater than or equal to 39 repetitions.
- Women of childbearing age must have a negative serum or urine pregnancy test result at the screening visit. Likewise, they must accept the use of adequate contraceptive methods at least 15 days prior to the screening visit, during the course of the clinical trial and at least 15 days after the last visit.
- In men who have a partner of childbearing age, accept the use of contraceptive methods.
- Ability to give informed consent and comply with the visits stipulated in the study.
You likely can't join if
- Clinically significant medical problems that, in the judgment of the investigators, may cause tissue damage to the CNS or limit its repair, or that may expose the patient to unjustified risk or harm, or cause the patient not to complete the study.
- Pregnancy or breastfeeding, or planning to become pregnant or patients of childbearing age not undergoing birth control methods (recommended by the Clinical Trial Facilitation Group (CTFG): http://www.hma.eu/fileadmin/dateien/Human_Medicines/ 01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf).
- Patients dependent on basic activities of daily living (ABDL) or with a degree of severe cognitive impairment that prevents participation/follow-up in the study (UHDRS, Unified Huntington Disease Rating Scale TFC < 7).
- Patients with active psychosis at the time of clinical evaluation.
- Advanced kidney failure.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.