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

Launched by FUNDACIÓN PÚBLICA ANDALUZA PARA LA GESTIÓN DE LA INVESTIGACIÓN EN SEVILLA · Jul 15, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the combined use of two vitamins, thiamine and biotin, to see if they can help people with Huntington's disease. Huntington's disease is a genetic condition that affects movement and can also lead to changes in mood and thinking. The researchers want to find out if taking these vitamins together is safe and if they can improve symptoms or slow down the disease's progression in patients who are in the mild to moderate stages of Huntington's disease. They will measure the effects by looking at changes in a specific substance in the fluid around the brain and spinal cord.

To be eligible for this trial, participants need to be adults diagnosed with Huntington's disease who show symptoms like movement problems or changes in mood and thinking. They should also have a genetic test showing a certain number of repetitions in the Huntington gene. Women who can become pregnant will need to have a negative pregnancy test and use birth control during the study. Participants will be monitored throughout the year-long study to ensure the treatment is safe and to track any changes in their condition. This trial is currently recruiting participants, so it's a great opportunity for those who qualify to contribute to important research that could benefit future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.
• • Severe renal failure.
• • Patients previously treated with thiamine and/or biotin or enrolled in other HD clinical trial with oligonucleotide antisense (IONIS-HTTRX (RG6042).