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Study on Clemastine and Fampridine for Patients with Multiple Sclerosis and Internuclear Ophthalmoparesis

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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 the effects of a medication called clemastine fumarate in treating two conditions: multiple sclerosis and internuclear ophthalmoparesis. Multiple sclerosis is a disease that affects the brain and spinal cord, leading to a range of symptoms such as vision problems, balance issues, and muscle weakness. Internuclear ophthalmoparesis is a condition that affects eye movement, making it difficult for the eyes to move together properly.

The purpose of the study is to evaluate whether clemastine fumarate can help improve eye movement in patients with these conditions. The study will involve taking clemastine fumarate in the form of tablets, and some participants may receive a placebo, which looks like the medication but does not contain the active ingredient. Another medication, Fampyra, which is used to improve walking in people with multiple sclerosis, will also be part of the study. Participants will take the medication orally, meaning by mouth, over a period of time.

Throughout the study, participants will be monitored to see how their eye movements change over time. The study will last for several months, with follow-up periods to check if any improvements continue after the treatment ends. The goal is to see if clemastine fumarate can provide lasting benefits by helping to repair the protective covering of nerves, known as myelin, which is often damaged in multiple sclerosis. This process is called remyelination, and the study aims to determine if clemastine fumarate can support this process effectively.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on a diagnosis of multiple sclerosis and internuclear ophthalmoparesis. Age must be between 18 and 70 years. Understanding the study's purpose and risks is necessary, and informed consent is required.
Step 2
Initial assessment
An initial assessment is conducted to measure eye movement using infrared oculography. This helps determine the baseline Versional Dysconjugacy Index (VDI).
Step 3
Treatment phase
The treatment involves taking Clemastine Milstein 1 mg tablets orally. The exact dosage and frequency are determined by the study protocol.
Additionally, Fampyra 10 mg prolonged-release tablets are administered orally. The dosage and frequency are specified in the study protocol.
Step 4
Monitoring and follow-up
The primary endpoint is the change in the Versional Dysconjugacy Index (VDI) from baseline, assessed at the end of the treatment phase (6 months) and during follow-up periods at 12, 24, and 36 months.
Regular follow-up assessments are conducted to evaluate the persistence of treatment effects and any lasting remyelination.
Step 5
Completion of the study
The study is estimated to conclude by December 31, 2027. Final assessments are conducted to gather comprehensive data on the treatment's efficacy and long-term effects.

Who can join the trial?

5 criteria

Have a clinically definite diagnosis of multiple sclerosis. This means a doctor has confirmed you have this condition.
Have a diagnosis of internuclear ophthalmoplegia. This is a specific eye movement problem that will be checked using a special test called infrared oculography during the screening.
Be between the ages of 18 and 70, including both 18 and 70.
Using disease modifying therapies is allowed. These are treatments that can change the course of multiple sclerosis.
Be able to understand the purpose and risks of the study and be willing to sign a form that shows you agree to participate.

Who cannot join the trial?

3 criteria

Patients who do not have a diagnosis of multiple sclerosis or internuclear ophthalmoparesis cannot participate. Internuclear ophthalmoparesis is a condition that affects eye movement.
Individuals who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Participants who are part of a vulnerable population, which means groups that might need special protection, are not eligible.

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Amsterdam UMC
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Amsterdam, The Netherlands

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Investigated drugs

Clemastine is being studied as a treatment to help repair nerve damage in patients with multiple sclerosis (MS) and a specific eye movement disorder called internuclear ophthalmoplegia (INO). The trial aims to see if this medication can improve eye movement problems and if these improvements last after the treatment ends.

What is already known about the treatment

Clemastine fumarate – Clemastine fumarate is administered orally in tablet form. It is currently being studied in clinical trials as a potential treatment for multiple sclerosis and internuclear ophthalmoparesis. The main therapeutic indication is to promote remyelination, which may help improve nerve function in these conditions. At the molecular level, clemastine fumarate works by blocking histamine receptors, which may indirectly support the repair of nerve coverings. It is classified as an antihistamine, commonly used to relieve allergy symptoms, but is being explored for its potential neurological benefits.

Investigated diseases

Multiple sclerosis
A chronic disease affecting the central nervous system, particularly the brain and spinal cord. It is characterized by damage to the protective covering of nerve fibers, leading to communication problems between the brain and the rest of the body. Symptoms can vary widely, including fatigue, difficulty walking, numbness, and muscle weakness. The disease often progresses with periods of relapses and remissions, or it may steadily worsen over time. The exact cause is unknown, but it is believed to involve an immune system attack on the nervous system. Environmental and genetic factors may contribute to its development.
Internuclear ophthalmoparesis
A disorder of eye movement caused by damage to the nerve pathways that coordinate the horizontal movement of the eyes. It results in the inability to move both eyes together in the same direction, leading to double vision or difficulty focusing. This condition is often associated with neurological diseases such as multiple sclerosis. Symptoms may include blurred vision, dizziness, and difficulty reading. The progression can vary, with some individuals experiencing improvement over time. It is typically diagnosed through clinical examination and imaging studies.