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Study on the Effects of Cladribine on Brain Cells in Patients with Multiple Sclerosis

Registered 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 the effects of a medication called MAVENCLAD, which contains the active substance cladribine, on a condition known as Multiple Sclerosis (MS). MS is a disease that affects the central nervous system, which includes the brain and spinal cord. The study aims to understand how cladribine treatment influences the activity of certain cells in the brain called microglial cells. These cells are part of the immune system in the brain and can become activated in MS, potentially contributing to the disease process.

The purpose of the study is to observe changes in microglial cell activity in different areas of the brain before and after 18 months of treatment with cladribine. Participants will undergo imaging tests, such as PET (Positron Emission Tomography) and MRI (Magnetic Resonance Imaging), to evaluate these changes. These imaging techniques help visualize the brain and assess the effects of the treatment on microglial cells and other brain structures.

Throughout the study, researchers will also monitor changes in the overall brain structure, including white and gray matter, and the presence of MS-related lesions. The study will compare these findings with those from healthy individuals and untreated MS patients to better understand the impact of cladribine on the disease. The study is expected to last for 18 months, providing valuable insights into the potential benefits of cladribine for people with Multiple Sclerosis.

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
Initial consent and eligibility
The first step involves signing an informed consent form. This confirms understanding and agreement to participate in the study.
Eligibility is determined based on specific criteria, including being between 35-55 years of age and having a diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the McDonald 2017 criteria.
Step 2
Treatment initiation
The treatment involves taking MAVENCLAD 10 mg tablets, which contain the active substance cladribine. The medication is taken orally.
The treatment is planned and indicated according to the label instructions.
Step 3
Treatment duration
The treatment with cladribine is administered over a period of 18 months.
During this time, the effect of the treatment on microglial cell activation in the brain is evaluated.
Step 4
Imaging assessments
Throughout the study, imaging techniques such as [11C]PK11195-PET and MRI are used to assess changes in microglial cell activation and brain structure.
These assessments occur at different time points to monitor changes in brain areas, including normal appearing white matter, grey matter, and chronic active lesions.
Step 5
End of study evaluations
At the end of the 18-month treatment period, final evaluations are conducted to assess the primary and secondary endpoints.
These include changes in microglial activation, lesion load, brain volume, and other imaging parameters.

Who can join the trial?

4 criteria

Sign the informed consent form, which is a document that explains the study and confirms your agreement to participate.
Be planned to receive **cladribine** treatment, which is a medication used for treating **Multiple Sclerosis**, and it should be suitable for you according to the medication guidelines.
Be between 35 and 55 years old at the time you sign the informed consent form.
Have a diagnosis of **RRMS** (Relapsing-Remitting Multiple Sclerosis) according to the **McDonald 2017 criteria**, which are guidelines used by doctors to diagnose this type of Multiple Sclerosis.

Who cannot join the trial?

1 criterion

There are no specific reasons listed that would prevent a patient from participating in this study.

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Investigated drugs

Cladribine is a medication used in this clinical trial to study its effect on microglial activation in the central nervous system. It is being evaluated for its ability to reduce inflammation in the brain by targeting specific immune cells. The trial aims to observe changes in brain areas before and after 18 months of treatment with cladribine, using advanced imaging techniques.

Cladribine

What is already known about the treatment

Cladribine – Cladribine is administered orally in tablet form. It is currently being studied for its effects on microglial activation in the central nervous system, particularly in patients with Multiple Sclerosis. The medication is primarily used to treat this condition by reducing the frequency of relapses and slowing the progression of disability. At the molecular level, cladribine works by targeting and depleting certain immune cells, which helps to reduce inflammation and immune system activity. It is classified as an immunosuppressant and is known for its ability to selectively target lymphocytes, which are a type of white blood cell involved in the immune response.

Investigated diseases

Multiple Sclerosis – Multiple Sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system attacking the protective covering of nerves, leading to communication problems between the brain and the rest of the body. Over time, this can cause deterioration or permanent damage to the nerves themselves. Symptoms can vary widely, including fatigue, difficulty walking, numbness, and muscle weakness. The progression of the disease can be unpredictable, with periods of remission and relapses. As the disease advances, it may lead to more severe physical and cognitive impairments.