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Study on Modafinil for Improving Cognitive Deficits in Multiple Sclerosis Patients

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 Multiple Sclerosis, a condition that affects the brain and spinal cord, leading to a range of symptoms including cognitive deficits, which are difficulties with thinking and memory. The trial will use a medication called Modafinil, which is taken in tablet form. Modafinil is being tested to see if it can help improve cognitive function in patients with Multiple Sclerosis.

The purpose of the study is to identify features that can predict how well patients will respond to Modafinil. The study will take place over a period of three months. During this time, participants will take Modafinil and undergo various assessments, including fMRI scans, which are special brain scans that help researchers see how the brain is working. These scans will be done at the beginning of the study and after three months of treatment. The study will also include tests and questionnaires to evaluate changes in cognitive function and quality of life.

Participants will be asked to take part in different activities and tests to help researchers understand the effects of Modafinil on brain function and connectivity. The study aims to gather information that could help in predicting which patients are likely to benefit from Modafinil treatment. This information could be valuable for improving treatment strategies for cognitive deficits in 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.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Functional MRI (fMRI) is performed to measure brain function and connectivity at rest. This occurs before and 3 hours after taking modafinil.

  2. Step 2

    Medication administration

    The medication used in this trial is Modafinil Generis 100 mg tablets. It is taken orally.

    The treatment period lasts for 3 months, during which the medication is administered as prescribed by the study protocol.

  3. Step 3

    Ongoing assessments

    Throughout the trial, changes in brain function and connectivity are monitored using fMRI. This includes a Go/no-Go task fMRI.

    Patient-reported outcomes and neuropsychological tests are conducted. These include the Perceived Deficits Questionnaire (PDQ), Symbol Digit Modalities Test (SDMT), Stroop test, MS-specific Quality of Life questionnaire, Work Productivity and Activity Impairment Questionnaire for MS (WPAI:MS), and Modified Fatigue Impact Scale (MFIS).

  4. Step 4

    End of treatment evaluation

    At the end of the 3-month treatment period, a final evaluation is conducted. This includes repeating the fMRI to assess changes in brain function and connectivity.

    The same patient-reported outcomes and neuropsychological tests are repeated to evaluate any changes since the beginning of the trial.

  5. Step 5

    Safety follow-up

    A safety follow-up period of 3 months is observed after the treatment ends. This is to monitor any delayed effects of the medication.

    Participants are required to use effective contraception methods during this period, as specified in the trial protocol.

Who can join the trial?

10 criteria

  • The participant must be willing and able to give informed consent to join the trial. This means they understand the study and agree to take part.
  • The participant must be able and willing to follow all the trial requirements, as judged by the medical investigator.
  • The participant must be able to read and write.
  • The participant must be male or female, aged between 18 and 64 years old at the time of signing the informed consent form.
  • The participant must have been diagnosed with **Relapsing-Remitting Multiple Sclerosis (MS)** or **Clinically Isolated Syndrome**. These are specific types of MS, diagnosed using certain criteria.
  • The participant must have an **Expanded Disability Status Score (EDSS)** of less than 6.5. This score measures the level of disability in people with MS.
  • The participant must have subjective cognitive complaints, meaning they feel they have problems with thinking or memory.
  • The participant must have a **Symbol Digit Modalities Test (SDMT)** score of 55 or less at screening. This test measures how quickly and accurately a person can match symbols with numbers.
  • Female participants who can have children and male participants whose partner can have children must agree to use effective contraception methods, not just hormonal ones, during the entire 6 months of the trial (3 months of treatment plus 3 months of safety follow-up).
  • Male participants must agree not to donate semen from the start of the study treatment until at least 90 days after the last treatment.

Who cannot join the trial?

8 criteria

  • Patients who are not diagnosed with multiple sclerosis. Multiple sclerosis is a condition that affects the brain and spinal cord.
  • Patients who are under 18 years old.
  • Patients who are unable to give informed consent. This means they cannot understand the study well enough to agree to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have other serious medical conditions that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had an allergic reaction to modafinil or similar medications. Modafinil is a medication used to help with wakefulness.
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Investigated drugs

Modafinil is a medication used in this clinical trial to help improve cognitive function in patients with Multiple Sclerosis. It is being studied to see how it affects brain activity and to identify which patients respond well to the treatment. The trial aims to understand the differences in brain features between those who benefit from the medication and those who do not, both at the start and after three months of treatment.

What is already known about the treatment

Modafinil – Modafinil is administered orally in tablet form. It is currently being studied in clinical trials for its potential to improve cognitive deficits in patients with multiple sclerosis. The main therapeutic indication for modafinil in this context is to enhance cognitive function. At the molecular level, modafinil works by influencing neurotransmitters in the brain, particularly by increasing the availability of dopamine. It is classified pharmacologically as a wakefulness-promoting agent.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501414-53-00Protocol codeMODAFIMSEstimated enrolment64 patientsSponsorCCAB Centro Clinico Academico Braga Associacao

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