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Study on the Safety and Effectiveness of Melatonin and Ocrelizumab for Patients with Primary Progressive Multiple Sclerosis

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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 Primary Progressive Multiple Sclerosis, a type of multiple sclerosis where symptoms gradually worsen over time. The treatment being tested involves the use of melatonin, a substance that is naturally produced by the body and is often associated with regulating sleep. In this study, melatonin is being used in combination with another medication called ocrelizumab, which is already used to treat multiple sclerosis. The trial will also include a group of participants who will receive a placebo, which is a substance with no active medication, to compare the effects.

The purpose of the study is to evaluate the safety and effectiveness of this treatment combination in patients with Primary Progressive Multiple Sclerosis. Participants in the study will be randomly assigned to receive either the melatonin and ocrelizumab combination or a placebo. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, which is known as a double-blind study. This helps ensure that the results are not influenced by expectations about the treatment.

Throughout the study, participants will be monitored for any changes in their condition, including the progression of their multiple sclerosis symptoms and any side effects they may experience. The study will also look at other factors such as quality of life, fatigue, and sleep disorders. The trial is expected to continue until March 2026, providing valuable information on whether this treatment approach can help manage the symptoms of Primary Progressive Multiple Sclerosis more effectively.

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 the diagnosis of primary progressive multiple sclerosis and ensuring no recent use of certain medications or supplements.

    Eligibility criteria include age between 18 and 65, specific scores on the Expanded Disability Status Scale, and stable doses of ocrelizumab for at least 9 months prior to the study.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either melatonin or a placebo. This process is single-blind, meaning participants do not know which treatment they are receiving.

  3. Step 3

    Treatment phase

    During the treatment phase, participants take the assigned medication orally. The medication includes melatonin, which is administered in combination with ocrelizumab.

    The dosage and frequency of melatonin are determined by the study protocol, and participants are required to adhere to the schedule for the duration of the trial.

  4. Step 4

    Regular monitoring

    Participants attend regular visits for monitoring. These visits assess neurological impairment and disability using specific scales, such as the Kurtzke Expanded Disability Status Scale and the Multiple Sclerosis Functional Composite scale.

    Additional assessments include monitoring for treatment-related adverse events, cerebral atrophy, fatigue, quality of life, sleep disorders, spasticity, and other health indicators.

  5. Step 5

    Completion and follow-up

    Upon completion of the treatment phase, participants undergo a final assessment to evaluate the overall impact of the treatment on disease progression and other health outcomes.

    The study is estimated to conclude by March 31, 2026, at which point all data will be analyzed to determine the safety and efficacy of melatonin in combination with ocrelizumab for treating primary progressive multiple sclerosis.

Who can join the trial?

8 criteria

  • Patients must visit the Multiple Sclerosis Unit at one of the specified hospitals in Seville.
  • Must have **Primary Progressive Multiple Sclerosis** as diagnosed by specific criteria from 2010.
  • Age must be between 18 and 65 years old.
  • Must have a level of neurological impairment measured by the **Expanded Disability Status Scale (EDSS)** between 2 and 7. This means having no disability or only symptoms that allow walking with support.
  • Must not have received any treatment that changes the immune system, except for **ocrelizumab** in stable doses for at least 9 months before joining the study. Also, must not have received treatments that suppress the immune system in the 3 months before the trial.
  • If there is a chance of pregnancy or fathering a child, must agree to use a highly effective birth control method during the trial.
  • Must not have taken **melatonin** or other dietary supplements like antioxidants or high doses of vitamins in the month before the trial.
  • Must be able to give informed consent and attend all scheduled study visits.

Who cannot join the trial?

4 criteria

  • Patients who do not have Primary Progressive Multiple Sclerosis cannot participate. This is a specific type of multiple sclerosis where symptoms gradually worsen over time.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
  • Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are not detailed here but are usually related to the patient's overall health and medical history.
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Investigated drugs

  • Ocrelizumab

    is a medication used in the trial to help manage primary progressive multiple sclerosis. It works by targeting specific cells in the immune system that are thought to contribute to the damage of nerve cells in multiple sclerosis. This medication is intended to slow the progression of the disease and reduce symptoms.

  • Melatonin

    is being tested in this trial for its potential benefits in patients with primary progressive multiple sclerosis. Melatonin is a hormone that regulates sleep-wake cycles and is being studied for its possible effects on inflammation and immune function, which may be beneficial in managing multiple sclerosis symptoms.

What is already known about the treatment

  • Ocrelizumab

    Ocrelizumab is administered through an intravenous infusion, typically given in a healthcare setting. It is currently approved and widely used in the treatment of primary progressive multiple sclerosis (PPMS). The medication works by targeting and depleting specific immune cells known as B cells, which are believed to play a role in the abnormal immune response seen in multiple sclerosis. Ocrelizumab is classified as a monoclonal antibody and is part of the disease-modifying therapies for multiple sclerosis.

  • Melatonin

    Melatonin is usually taken orally in the form of tablets or capsules. It is a naturally occurring hormone that is being studied for its potential benefits in managing primary progressive multiple sclerosis, although it is not yet widely recognized for this use in medical literature. Melatonin is thought to exert its effects by regulating sleep-wake cycles and possibly modulating immune responses. It is classified as a dietary supplement and is commonly used for sleep disorders.

Investigated diseases

Primary Progressive Multiple Sclerosis – This is a type of multiple sclerosis characterized by a gradual worsening of neurological function from the onset of symptoms, without early relapses or remissions. It primarily affects the spinal cord and brain, leading to increasing disability over time. Symptoms may include muscle weakness, difficulty walking, and problems with coordination and balance. As the disease progresses, individuals may experience increased difficulty with mobility and daily activities. Cognitive changes, such as memory and concentration issues, can also occur. The progression of symptoms can vary widely among individuals, with some experiencing more rapid changes than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-508457-10-00Protocol codeMELATOMS-1Estimated enrolment50 patientsSponsorFundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

sourced from the EU Clinical Trials Register and site verification

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