RecruitingRare disease

Study on the Use of Thiamine and Biotin for Patients with Huntington's Disease

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Huntington's disease, a condition that affects the brain and causes problems with movement, thinking, and behavior. The study will use a combination of two treatments: Thiamine, also known as Vitamin B1, which is provided in a film-coated tablet form, and Biotin, also known as Vitamin H, which is provided in a hard capsule form. The purpose of the study is to evaluate the safety and tolerability of this combined therapy in patients with Huntington's disease.

Participants in the study will take both Thiamine and Biotin orally. Throughout the study, there will be regular check-ups with a neurologist, both in-person and remotely, to monitor the participants' health and any side effects. Blood and other tests will be conducted to ensure the safety of the treatment. The study will also measure levels of Thiamine in the body and assess changes in the brain and motor functions over time.

The study will last until the end of 2025, with regular visits and assessments to track the progress and effects of the treatment. Participants will be monitored for any changes in their condition, including motor skills and overall quality of life. The goal is to gather information that could help improve treatment options for people with Huntington's disease in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
The initial visit involves a comprehensive clinical examination conducted by a neurologist. This includes a review of medical history and a physical examination.
Blood and cerebrospinal fluid (CSF) samples are collected to measure levels of thiamine and other relevant biomarkers.
Step 2
Medication administration
The patient begins taking thiamine and biotin in the form of hard capsules. These are taken orally.
The dosage and frequency of administration are determined by the study protocol and adjusted as necessary during the trial.
Step 3
Dose escalation period
During this period, the dosage of the medication may be gradually increased. This is done to assess the patient's tolerance to the treatment.
Regular blood tests are conducted to monitor liver and kidney function.
Step 4
Quarterly in-person visits
Every three months, the patient attends an in-person visit for a clinical examination and to discuss any side effects experienced.
Motor skills are assessed using the Unified Huntington's Disease Rating Scale (UHDRS) and other quantitative motor assessments.
Step 5
Remote visits
In addition to in-person visits, remote consultations are scheduled to monitor the patient's progress and address any concerns.
These visits include discussions about any adverse effects and overall treatment tolerability.
Step 6
End of study assessments
At the conclusion of the study, final assessments are conducted to measure changes in thiamine levels in the blood and CSF.
The patient's quality of life and global impression of change are evaluated using standardized scales.

Who can join the trial?

4 criteria

Adult patients with **Huntington's disease**. This means they have symptoms like movement problems (such as jerky movements called chorea, muscle stiffness called dystonia, or slow movements called bradykinesia) and/or mental health symptoms. They also need to have a genetic test showing a specific change in their DNA, with a number of repeats in a part of the gene called the **CAG triplet** being 39 or more.
Women who can have children must have a negative pregnancy test before starting the study. They also need to agree to use reliable birth control methods starting at least 15 days before joining the study, during the study, and for at least 15 days after the study ends.
Men with partners who can have children must agree to use birth control methods.
Participants must be able to understand the study details and agree to take part by signing a consent form. They also need to be able to attend all the study visits.

Who cannot join the trial?

7 criteria

Patients who are not diagnosed with **Huntington's disease** cannot participate. **Huntington's disease** is a condition that affects the brain and causes movement, thinking, and emotional problems.
Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
Patients who are not able to take oral medications cannot participate. Oral medications are those that are taken by mouth.
Patients who have any other medical condition that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.

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Verified sites

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Hospital Universitario Donostia
Verified
Donostia / San Sebastian, Spain
Virgen del Rocío University Hospital
Verified
Sevilla, Spain

Trial locations

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Investigated drugs

Thiamine
is a vitamin, also known as Vitamin B1, that helps the body convert food into energy. It is important for the functioning of the heart, muscles, and nervous system. In this trial, thiamine is used to see if it can help improve symptoms or slow the progression of Huntington's disease.
Biotin
is another vitamin, known as Vitamin B7, that plays a key role in the health of the skin, nerves, digestive tract, metabolism, and cells. It is being tested in combination with thiamine to determine if it can enhance the effects of thiamine in treating Huntington's disease.

What is already known about the treatment

Thiamine
Thiamine is administered orally and is currently being studied in combination with biotin for its potential benefits in treating Huntington's disease. It is a well-known vitamin, commonly referred to as Vitamin B1, and is essential for energy metabolism. Thiamine works by helping convert nutrients into energy at the cellular level. It is classified as a vitamin and is generally recognized for its role in supporting nerve function and overall health.
Biotin
Biotin is also taken orally and is being investigated alongside thiamine for its effects on Huntington's disease. Known as Vitamin B7, biotin is crucial for the metabolism of fats, carbohydrates, and proteins. It acts by supporting various enzymatic reactions in the body, contributing to healthy skin, hair, and nails. Biotin is classified as a vitamin and is widely used for its benefits in maintaining metabolic health.

Investigated diseases

Huntington's Disease – Huntington's disease is a genetic disorder that affects the brain, leading to the progressive breakdown of nerve cells. It typically manifests in adulthood and is characterized by a combination of movement disorders, cognitive decline, and psychiatric symptoms. As the disease progresses, individuals may experience involuntary movements, difficulties with coordination, and changes in mood and behavior. Cognitive abilities, such as thinking and reasoning, gradually deteriorate, impacting daily functioning. The symptoms worsen over time, affecting the individual's ability to perform everyday tasks. The progression of the disease varies among individuals, but it generally leads to increasing disability.