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.
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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