Study on Cladribine for Patients with Multiple Sclerosis to Evaluate Brain Network Changes

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What is this study about?

This clinical trial is focused on studying Multiple Sclerosis, a condition that affects the brain and spinal cord, leading to a range of symptoms such as problems with vision, arm or leg movement, sensation, or balance. The treatment being investigated in this study is a medication called Cladribine, which is taken in the form of tablets. The purpose of the study is to explore how this medication affects certain brain functions in people with Multiple Sclerosis.

Participants in the study will take Cladribine tablets and undergo various assessments over a period of 18 months. These assessments will include imaging tests like rs-fMRI (resting state functional magnetic resonance imaging), which helps to observe brain activity, and other tests to measure changes in brain structure and function. The study aims to understand how the brain’s connectivity and activity change with the treatment, particularly focusing on areas like the corpus callosum, thalamus, and hippocampus, which are important for cognitive and emotional functions.

Throughout the study, researchers will also evaluate how the treatment impacts cognitive performance, emotional and behavioral aspects, and overall neurological status. This will help in understanding the broader effects of Cladribine on individuals with Multiple Sclerosis, providing insights into its potential benefits and any changes in brain activity and structure over time.

1 initial visit

Upon joining the clinical trial, you will have an initial visit. During this visit, your eligibility will be confirmed based on criteria such as age, diagnosis of multiple sclerosis (MS), and recent start of treatment with cladribine tablets.

You will be asked to sign a consent form, which indicates your agreement to participate in the study.

2 medication administration

You will continue taking MAVENCLAD 10 mg tablets orally as part of your treatment for MS. The specific dosage and frequency will be determined by your healthcare provider, based on your individual treatment plan.

3 regular monitoring

Throughout the trial, you will have regular appointments to monitor your health and the effects of the medication. These appointments may include physical exams, blood tests, and other assessments as needed.

4 functional activity assessment

At 18 months, changes in your brain’s resting state functional activity will be assessed using a special type of imaging called rs-fMRI (resting state functional magnetic resonance imaging). This will help evaluate the impact of the treatment on your brain activity.

5 additional assessments

Additional assessments will be conducted to evaluate changes in brain structure and function, including imaging of brain tracts, volumetric measures of key brain regions, and connectivity related to cognitive performance.

Your cognitive and emotional functioning will also be assessed using neuropsychological tests, and your clinical neurological status will be evaluated.

6 end of trial

The trial is expected to conclude by December 31, 2025. At the end of the trial, a final assessment will be conducted to evaluate the overall effects of the treatment on your condition.

Who Can Join the Study?

Have a diagnosis of Multiple Sclerosis (MS) according to the McDonald 2010 criteria. This means that a doctor has confirmed you have MS using specific guidelines.
Be between 30 and 55 years old.
Have started treatment with cladribine tablets within the last month. Cladribine is a medication used to treat MS.
Be willing to sign a consent form, which means you agree to participate in the study after understanding all the details.

Who Cannot Join the Study?

Patients who are not diagnosed with Multiple Sclerosis cannot participate. Multiple Sclerosis is a condition that affects the brain and spinal cord.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified in the provided data.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have difficulty giving informed consent or are at higher risk of harm.
Patients who do not meet other unspecified criteria set by the study cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital General Universitario Gregorio Maranon	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.06.2023

Trial locations

Investigated drugs:

Cladribine

Cladribine is a medication used in this clinical trial to treat patients with multiple sclerosis, a condition that affects the brain and spinal cord. Cladribine works by reducing the number of certain immune cells that are thought to be involved in the damage to the nervous system seen in multiple sclerosis. This medication is taken in tablet form and is designed to help manage the symptoms of the disease and potentially slow its progression. In this trial, researchers are studying how Cladribine affects the brain’s activity, particularly in a network called the default mode network, which is involved in various brain functions.

Investigated diseases:

Multiple sclerosis

Multiple Sclerosis – Multiple Sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It involves an abnormal immune response that damages the protective covering of nerve fibers, known as myelin. This damage disrupts communication between the brain and other parts of the body. The disease often begins with episodes of symptoms that can include fatigue, difficulty walking, numbness, and vision problems. Over time, these symptoms may worsen or become more frequent. The progression of the disease can vary widely among individuals, with some experiencing long periods of remission and others facing a steady decline in function.

Trial ID:

2023-504577-21-00

Protocol code:

CLADRI_NET

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Cladribine for Patients with Multiple Sclerosis to Evaluate Brain Network Changes

What is this study about?

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