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Study on Amantadine and Transcranial Magnetic Stimulation for Reducing Fatigue in Multiple Sclerosis Patients

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What is this study about?

This clinical trial is focused on studying Multiple Sclerosis (MS), a condition that affects the brain and spinal cord, leading to a range of symptoms including fatigue. The study is testing the effectiveness of a treatment using Amantadine, a medication that can help with fatigue, and a technique called Transcranial Magnetic Stimulation (TMS), which involves using magnetic fields to stimulate nerve cells in the brain. The purpose of the study is to compare the effects of these treatments, both alone and in combination, against a placebo to see how well they reduce fatigue in people with MS.

Participants in the study will receive either the medication, the magnetic stimulation, both treatments together, or a placebo. The study is designed to be a crossover trial, meaning that participants will receive each treatment option at different times during the study. This approach helps researchers understand the effects of each treatment on fatigue. The study will last for several weeks, and participants will be asked to complete questionnaires about their fatigue levels and quality of life at different points throughout the study.

The main goal is to see if there is a change in fatigue levels as measured by a specific questionnaire. Additionally, the study will look at how the treatments affect participants’ quality of life and any symptoms of depression. The results will help determine if these treatments can be effective options for managing fatigue in people with MS.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes evaluating the Disability Scale Score (EDSS), Fatigue Severity Scale (FSS), and Beck Depression Inventory (BDI) scores.

Eligibility requires an EDSS score between 1.5 and 4.5, an FSS score greater than 4, and a BDI score less than 30. Additionally, no disease outbreak should have occurred in the three months prior to recruitment.

2 washout period

A four-week washout period is required for any fatigue-related medications previously taken. This includes drugs such as amantadine, modafinil, and others.

3 treatment phase

The treatment phase involves the administration of Amantadine Level 100 mg capsules taken orally. The dosage and frequency are determined by the study protocol.

This phase also includes the application of transcranial magnetic stimulation (TMS), either alone or in combination with amantadine, or a placebo.

4 evaluation of effectiveness

The primary measure of effectiveness is the change in the Modified Fatigue Impact Scale (MFIS) scores at six weeks.

Secondary evaluations include changes in patient-perceived quality of life using the SF-12 scale and assessments of depressive symptoms with the Beck Depression Inventory-II.

5 completion and follow-up

Upon completion of the treatment phase, a final assessment is conducted to evaluate the outcomes.

The study is estimated to conclude by November 30, 2024, with follow-up assessments as required by the study protocol.

Who Can Join the Study?

  • Must have a diagnosis of multiple sclerosis (MS).
  • Must have a Disability scale score (EDSS) between 1.5 and 4.5 points. This score measures the level of disability in MS.
  • Must have a Fatigue Severity Scale (FSS) score greater than 4 points. This scale measures how severe the fatigue is.
  • Must have a Beck Depression Inventory (BDI) score less than 30 points. This score assesses the level of depression.
  • Must not have had an outbreak of the disease in at least three months before joining the study. An outbreak is a sudden worsening of symptoms.
  • Must have stopped taking any drugs related to fatigue for at least four weeks. These drugs include amantadine, modafinil, methylphenidate, acetyl-L-carnitine, and certain cannabis products.
  • Must be able to sign the Informed Consent form, which means understanding the study and agreeing to participate.
  • Must be between the ages of 18 and 64 years old.
  • Both males and females can participate.

Who Cannot Join the Study?

  • Patients who do not have a diagnosis of multiple sclerosis (MS) cannot participate.
  • Patients who are not experiencing fatigue related to MS cannot participate.
  • 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 unable to give consent, cannot participate.
  • Patients who are not willing or able to follow the study procedures cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta Del Mar Cadiz Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
07.11.2022

Trial locations

Investigated drugs:

Amantadine is a medication used in this trial to help reduce fatigue in patients with multiple sclerosis. It is known to have effects on the brain that may help improve energy levels and reduce tiredness.

Transcranial Magnetic Stimulation (TMS) is a non-invasive therapy that uses magnetic fields to stimulate nerve cells in the brain. In this trial, TMS is being tested to see if it can help reduce fatigue in people with multiple sclerosis, either on its own or in combination with amantadine.

Investigated diseases:

Multiple Sclerosis – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It occurs when the immune system mistakenly attacks the protective covering of nerve fibers, leading to communication problems between the brain and the rest of the body. Symptoms can vary widely and may include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The disease often progresses with periods of new symptoms or relapses followed by periods of remission. Over time, some people may experience a gradual worsening of symptoms. The exact cause of multiple sclerosis is unknown, but it is believed to involve a combination of genetic and environmental factors.

Trial ID:
2024-516732-97-00
Protocol code:
FETEM
NCT ID:
NCT05809414
Trial Phase:
Therapeutic confirmatory (Phase III)

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