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Study on the Effects of Siponimod for Patients with Secondary Progressive Multiple Sclerosis

Verified siteRegistered 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 the effects of a treatment for secondary progressive multiple sclerosis (SPMS), a type of multiple sclerosis where the disease gradually worsens over time. The treatment being tested is a medication called siponimod, which is available in the form of film-coated tablets known as Mayzent. The study aims to explore how this medication affects chronic inflammation in the brain and spinal cord, which is a key feature of SPMS.

Participants in the study will take siponimod and be monitored over a period of two years. During this time, researchers will collect and analyze samples of blood and cerebrospinal fluid (CSF), the fluid surrounding the brain and spinal cord, to understand how the medication impacts inflammation. The study will also involve regular assessments of participants' neurological health, including the use of MRI scans to track changes in the brain and spinal cord.

Throughout the study, researchers will evaluate various health markers, including those related to inflammation and nerve damage, as well as changes in cognitive function and physical abilities. The goal is to determine the effectiveness of siponimod in managing SPMS and to gather information on any side effects that may occur during the treatment period. Participants will also be compared to a control group receiving a placebo to assess the true impact of the medication.

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, neurological evaluations, and MRI scans performed within the last two years.

    Eligibility criteria include being between 18-65 years old, having a specific type of multiple sclerosis (MS), and meeting certain health conditions.

  2. Step 2

    Baseline measurements

    Baseline measurements are taken to establish a starting point for the study. This involves collecting blood and cerebrospinal fluid (CSF) samples to evaluate markers of inflammation and neurodegeneration.

    Additional assessments include evaluating cognitive function and physical abilities using the Expanded Disability Status Scale (EDSS).

  3. Step 3

    Medication administration

    The medication siponimod is administered orally in the form of film-coated tablets. The dosage begins with Mayzent 0.25 mg tablets, gradually increasing to Mayzent 2 mg tablets as tolerated.

    The medication is taken daily, and the treatment continues for a duration of two years.

  4. Step 4

    Follow-up assessments

    Regular follow-up assessments are conducted throughout the study to monitor progress and any side effects. These include blood and CSF sample collection, MRI scans, and evaluations of cognitive and physical functions.

    The primary focus is on changes in CSF markers of inflammation and other health indicators.

  5. Step 5

    Final evaluation

    At the end of the two-year treatment period, a final evaluation is performed. This includes comprehensive assessments similar to the baseline measurements.

    The study aims to evaluate the overall effect of the medication on inflammation and disease progression.

Who can join the trial?

7 criteria

  • Must be between the ages of 18 and 65 years old.
  • Must have an active progressive course of **Multiple Sclerosis (MS)**, which means the disease is getting worse after initially having periods of symptoms that come and go. This includes having a progression in the **Expanded Disability Status Scale (EDSS)** of at least 1 point, a history of relapses, or new changes seen on an **MRI** scan in the last 2 years.
  • Must have had a **3T MRI** scan done in the last 2 years, which includes specific types of images: 3D T1 weighted Fast Field Echo (FFE), 3D Fluid Attenuated Inversion Recovery (FLAIR), and 3D Echo Planar Imaging Susceptibility weighted.
  • Must have detailed medical history records, including neurological evaluations done at least twice in the past two years or once in the past year.
  • Must have an **EDSS** score between 3.0 and 6.0, which measures the level of disability in MS.
  • Must have been in the progressive phase of the disease for less than 5 years.
  • Female participants must not be pregnant or breastfeeding at the start of the study or during the study. They must have a negative pregnancy test before joining and use highly effective birth control methods during the study and for at least 10 days after stopping treatment. These methods include hormonal contraception, intrauterine devices, or other reliable methods. Male participants must use a condom if their partners can become pregnant, and the female partner must also use a highly effective birth control method.

Who cannot join the trial?

3 criteria

  • Patients who do not have secondary progressive MS cannot participate. This is a specific type of multiple sclerosis, a disease 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 here, but it is important for eligibility.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

Siponimod is a medication used in this clinical trial to treat patients with secondary progressive multiple sclerosis (SPMS). The trial aims to evaluate how this medication affects chronic inflammation in the body, particularly by looking at advanced immunological measures in both blood and cerebrospinal fluid. Patients in the study will be treated with siponimod and monitored over a period of at least two years to assess its effectiveness.

What is already known about the treatment

Siponimod – Siponimod is administered orally in tablet form and is currently being studied for its effects on secondary progressive multiple sclerosis (SPMS). It is approved for use in treating SPMS and is well-documented in medical literature. The main therapeutic indication for siponimod is to manage and slow the progression of SPMS. At the molecular level, siponimod works by selectively modulating sphingosine-1-phosphate receptors, which play a role in immune cell migration, thereby reducing inflammation in the central nervous system. It is classified pharmacologically as a sphingosine-1-phosphate receptor modulator.

Investigated diseases

Secondary Progressive Multiple Sclerosis – This is a form of multiple sclerosis characterized by a gradual worsening of neurological function over time. Initially, individuals may experience periods of relapses and remissions, but eventually, the disease progresses steadily without clear periods of recovery. Symptoms can include increased disability, such as difficulty walking, muscle stiffness, and cognitive changes. The progression of the disease can vary significantly among individuals, with some experiencing a slow decline and others a more rapid deterioration. The underlying cause involves chronic inflammation and damage to the central nervous system, particularly affecting the brain and spinal cord. As the disease advances, it can lead to significant impairment in daily activities and quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512283-65-00Protocol codeGR-2021-12373041Estimated enrolment40 patientsSponsorAzienda Ospedaliera Universitaria Integrata Verona

sourced from the EU Clinical Trials Register and site verification

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