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Study on Cladribine for Treating Secondary Progressive Multiple Sclerosis in Patients with Recent Progression and No Recent Relapses

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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 medication called cladribine on patients with a specific type of multiple sclerosis known as secondary progressive multiple sclerosis (SPMS). Multiple sclerosis is a disease that affects the brain and spinal cord, leading to symptoms like muscle weakness, vision problems, and difficulties with coordination and balance. In the secondary progressive form, the disease gradually worsens over time. The study will compare the effects of cladribine, which is given as a subcutaneous injection, to a placebo. The main goal is to see if cladribine can slow down the loss of brain volume in patients with SPMS.

Participants in the study will receive either cladribine or a placebo over a period of time. The study will monitor changes in brain volume and other health indicators to assess the effectiveness and safety of cladribine. The trial will also look at how the treatment affects disability progression, cognitive function, and quality of life. Additionally, various tests, including MRI scans, will be used to track changes in the brain and spinal cord. The study aims to provide valuable information on whether cladribine can be a beneficial treatment option for people with SPMS.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The study begins with an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination.

    Eligibility is based on criteria such as age, diagnosis of secondary progressive multiple sclerosis (SPMS), and progression of the disease over the last 24 months.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the study medication, cladribine, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Treatment administration

    The treatment involves subcutaneous injections of cladribine or placebo. The dosage is 1 mg/ml, administered as a solution for infusion.

    The treatment is given over a period of 26 weeks, with specific schedules determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Participants undergo regular monitoring to assess the safety and efficacy of the treatment. This includes physical examinations, blood tests, and imaging studies.

    The primary goal is to evaluate the slowing of brain volume loss compared to placebo.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, participants undergo a comprehensive evaluation to assess changes in disability, cognitive function, and quality of life.

    The study also measures changes in brain imaging and serum biomarkers.

  6. Step 6

    Long-term follow-up

    Participants continue to be monitored until the end of the study, which is estimated to conclude in June 2027.

    The long-term follow-up focuses on assessing the sustained effects of the treatment on disease progression and overall health.

Who can join the trial?

10 criteria

  • Provide a written agreement to participate in the study.
  • Have a diagnosis of **Secondary Progressive Multiple Sclerosis (SPMS)**, which is a type of multiple sclerosis that follows an initial relapsing-remitting course.
  • Show a history of worsening neurological symptoms over at least the past 24 months. This means an increase in the **Expanded Disability Status Scale (EDSS)** score by at least 1 point if the score is 5 or less, or by at least 0.5 point if the score is more than 5. The EDSS is a method to measure disability in people with multiple sclerosis.
  • Have not experienced any new attacks or relapses of the disease in the last 12 months.
  • Have a baseline EDSS score between 3.5 and 7.5.
  • Be between 30 and 65 years old.
  • Have had symptoms of the disease for at least 10 years.
  • For women who can have children: Provide a written statement agreeing to stop having heterosexual intercourse or use effective birth control during the study and for at least 6 months after the last dose of the study drug. Effective birth control methods include surgical procedures like tubal ligation, partner sterilization, hormonal birth control, or certain types of **Intrauterine Devices (IUDs)**. Hormonal birth control must be used with a barrier method like condoms. Temporary methods like the calendar method are not acceptable. Women must also agree not to donate eggs during this time.
  • For men: Provide a written statement agreeing to stop having heterosexual intercourse or use condoms and ensure their female partners use contraception during the study and for at least 6 months after the last dose. Men must also agree not to donate semen during this time.
  • Be able to follow the study requirements, as determined by the researcher.

Who cannot join the trial?

3 criteria

  • Patients who have had a relapse in the last 12 months. A relapse is a sudden worsening of symptoms.
  • Patients who have not experienced progression in the last 24 months. Progression means the disease has gotten worse over time.
  • Patients who are part of a vulnerable population. This refers to groups of people who may need special protection or care.
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Investigated drugs

Cladribine is a medication being studied for its effectiveness and safety in treating patients with secondary progressive multiple sclerosis (SPMS). In this trial, it is administered under the skin. The main goal is to see if it can slow down the loss of brain volume in patients who have experienced disease progression in the last two years but have not had any relapses in the past year.

What is already known about the treatment

Cladribine – Cladribine is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating secondary progressive multiple sclerosis (SPMS). This medication is primarily indicated for patients with SPMS who have experienced disease progression without recent relapses. Cladribine works by targeting and reducing certain immune cells, which helps to slow down the loss of brain volume associated with the disease. It is classified as an immunosuppressive agent, which means it helps to suppress the immune system's activity to prevent it from attacking the body's own tissues.

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 a relapsing-remitting phase, where symptoms flare up and then improve. As the disease progresses, the relapses become less frequent, and a steady decline in function occurs. This progression can lead to increased disability, affecting mobility, balance, and coordination. Cognitive changes and fatigue are also common as the disease advances. The condition is marked by changes in brain volume and the presence of lesions detectable through MRI.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516992-33-02Protocol code504-15-021-21003Estimated enrolment188 patientsSponsorInstytut Psychiatrii I Neurologii

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