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Study on the Effectiveness and Safety of Sodium Cromoglicate for Treating Fatigue in Multiple Sclerosis Patients

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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 treatment for Multiple Sclerosis, a disease that affects the brain and spinal cord, leading to a range of symptoms including fatigue. The treatment being tested is called Sodium Cromoglicate, which is taken orally. The study will compare the effects of Sodium Cromoglicate with a placebo to see how well it works in reducing fatigue in patients with Multiple Sclerosis.

The purpose of the study is to evaluate how effective Sodium Cromoglicate is in managing fatigue symptoms in people with Multiple Sclerosis. Participants in the study will receive either the Sodium Cromoglicate treatment or a placebo over a period of time. The study will monitor changes in fatigue levels and other related symptoms to determine the treatment's impact.

Throughout the study, participants will undergo various assessments to track their fatigue and other symptoms. These assessments will help researchers understand the potential benefits of Sodium Cromoglicate for people living with Multiple Sclerosis. The study aims to provide valuable insights into the treatment's safety and effectiveness, contributing to better management of the disease.

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 verifying age, diagnosis of multiple sclerosis, and the presence of moderate fatigue and urinary dysfunction.

    Eligibility criteria include being between 18 and 60 years old, having a diagnosis of multiple sclerosis according to the 2017 McDonald criteria, and being clinically stable for the last 6 months.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is performed to measure fatigue and other symptoms. This involves completing the Modified Fatigue Impact Scale (MFIS) and other questionnaires related to fatigue and urinary symptoms.

    Additional assessments may include the Expanded Disability Status Scale (EDSS) and various quality of life questionnaires.

  3. Step 3

    Treatment phase

    Participants receive either sodium cromoglicate or a placebo. The medication is taken orally, with a dosage ranging from 200 to 400 mg.

    The treatment aims to evaluate the effect on fatigue in patients with multiple sclerosis.

  4. Step 4

    Follow-up visits

    Regular follow-up visits are scheduled to monitor progress and any side effects. These visits include repeating the fatigue and urinary symptom assessments.

    The Modified Fatigue Impact Scale (MFIS) is used at each visit to track changes from the baseline.

  5. Step 5

    End-of-treatment evaluation

    At the end of the treatment period, a final evaluation is conducted. This includes a comprehensive assessment of fatigue using the MFIS and other related scales.

    The results are compared to the baseline to determine the efficacy of the treatment.

Who can join the trial?

5 criteria

  • Age between 18 and 60 years.
  • Diagnosis of multiple sclerosis according to the 2017 McDonald criteria, with more than 6 months of follow-up and clinically stable (without flare-ups or new lesions) in the last 6 months.
  • EDSS between 1.0 and 6.5 points. EDSS stands for Expanded Disability Status Scale, which is a method to measure the level of disability in people with multiple sclerosis.
  • Presence of moderate fatigue for at least 6 months, defined by a score on the MFIS scale of 33 points or more. MFIS stands for Modified Fatigue Impact Scale, which measures the impact of fatigue on a person's life.
  • Presence of urinary dysfunction, defined by 2 points or more on the ABSST Test. ABSST stands for Actionable Bladder Symptom Screening Tool, which is used to assess bladder issues.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with multiple sclerosis cannot participate. Multiple sclerosis is a condition that affects the brain and spinal cord, causing a range of symptoms.
  • Patients who are under 18 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship, cannot participate.
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Investigated drugs

Cromoglycate is being studied as a new treatment for patients with multiple sclerosis. The trial aims to evaluate its effectiveness in reducing fatigue, which is a common symptom in people with this condition. The medication is taken orally and is being compared to a placebo to determine its efficacy and safety.

What is already known about the treatment

Disodium Cromoglycate – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating fatigue associated with multiple sclerosis. Disodium cromoglycate is primarily known for its role in stabilizing mast cells, which helps prevent the release of inflammatory substances. It is classified as a mast cell stabilizer and is being evaluated for its effectiveness and safety in managing symptoms of multiple sclerosis.

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. Over time, this can cause permanent damage or deterioration of the nerves themselves. The disease often begins with mild symptoms such as fatigue, numbness, or tingling, and can progress to more severe symptoms like muscle weakness, vision problems, and difficulties with coordination and balance. The progression of symptoms can vary widely among individuals, with some experiencing long periods of remission and others facing a steady decline in function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507541-29-00Protocol codeCAMINAEstimated enrolment120 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Clinico San Carlos

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