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Study on Istradefylline for Reducing Brain Inflammation in Patients with 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 Progressive Multiple Sclerosis (MS), a condition where the immune system mistakenly attacks the protective covering of nerves, leading to communication problems between the brain and the rest of the body. The trial will evaluate the effects of a medication called Istradefylline, which is taken orally in the form of a tablet. Istradefylline is being tested to see if it can reduce inflammation in the brain, which is a key issue in progressive MS. Some participants will receive Istradefylline, while others will receive a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to explore whether Istradefylline can help reduce the activation of certain brain cells called microglia, which are involved in the inflammation process in MS. Participants will take the medication once daily for a period of up to six months. Throughout the study, participants will undergo various tests, including brain imaging techniques like PET scans, to monitor changes in brain activity and inflammation. These tests will help researchers understand how the medication affects the brain compared to the placebo.

In addition to brain imaging, the study will also assess changes in physical abilities, such as walking speed and hand dexterity, as well as cognitive functions and overall quality of life. These assessments will provide a comprehensive view of how Istradefylline might impact the symptoms and progression of progressive MS. The study aims to gather valuable information that could lead to better treatment options for individuals living with this challenging condition.

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

    Joining the study

    Upon joining the study, informed consent is required. This involves understanding the study's purpose and agreeing to participate.

    Eligibility is confirmed based on criteria such as age, diagnosis of progressive multiple sclerosis, and language proficiency.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes a TSPO-PET scan to evaluate brain activity and MRI scans to assess brain lesions.

    The Expanded Disability Status Scale (EDSS) score is recorded to evaluate the level of disability.

  3. Step 3

    Medication administration

    Participants are randomly assigned to receive either istradefylline or a placebo. Istradefylline is administered orally at a dose of 40 mg once daily.

    The duration of medication administration is determined by the study protocol, continuing until the end of the treatment phase.

  4. Step 4

    Ongoing monitoring

    Regular monitoring is conducted to track changes in brain activity and lesion characteristics using TSPO-PET and MRI scans.

    Participants' health and any side effects are monitored throughout the study.

  5. Step 5

    Final assessment

    At the end of the treatment phase, a final TSPO-PET scan is performed to compare with the baseline scan.

    Additional assessments may include tests for hand dexterity, walking speed, cognitive function, and quality of life.

  6. Step 6

    Study completion

    Upon completion of the study, participants may receive information about the study's findings and their individual results.

    The study is estimated to conclude by November 30, 2026.

Who can join the trial?

7 criteria

  • Provide a signed document that shows you understand and agree to participate in the study.
  • Be a man or woman aged between 18 and 67 years old at the time of agreeing to participate.
  • Have a diagnosis of **Primary Progressive Multiple Sclerosis** or **non-active Secondary Progressive Multiple Sclerosis**. This means you have not had any relapses, or worsening of symptoms, in the last 2 years.
  • Have a score between 3.5 and 7.5 on the **Expanded Disability Status Scale (EDSS)**, which is a way to measure how much the disease affects your daily life.
  • Show signs that the disease has gotten worse in the last two years, as determined by your doctor. This could be through a doctor's evaluation or by seeing changes in brain scans called **T1 lesions**.
  • Be able to follow all the study procedures, which means having enough vision, hearing, and other abilities, and having completed at least the 8th grade in school.
  • Be able to speak and understand the Finnish language fluently.

Who cannot join the trial?

4 criteria

  • Patients who do not have progressive multiple sclerosis cannot participate. This is a type of multiple sclerosis where symptoms gradually get worse over time.
  • 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.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not excluded from this study.
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Investigated drugs

Istradefylline is being studied for its potential to reduce microglial activation in the brain of patients with progressive multiple sclerosis. It is taken orally once a day. The trial aims to see if this medication can change certain brain activity patterns in patients with this condition.

What is already known about the treatment

Istradefylline – This medication is administered orally, typically in the form of a tablet taken once daily. It is currently being studied in clinical trials for its potential benefits in treating progressive multiple sclerosis, specifically to reduce microglial activation in the brain. Istradefylline is primarily known for its use in Parkinson's disease, but its application in multiple sclerosis is under investigation. It works by blocking adenosine A2A receptors, which may help in reducing inflammation and neurodegeneration. Istradefylline is classified as an adenosine receptor antagonist.

Investigated diseases

Progressive Multiple Sclerosis – Progressive multiple sclerosis is a form of multiple sclerosis characterized by a gradual worsening of neurological function over time. Unlike relapsing forms, it does not have distinct relapses or remissions. The disease affects the central nervous system, leading to symptoms such as muscle weakness, coordination problems, and cognitive difficulties. As it progresses, individuals may experience increased disability and challenges with mobility. The progression can vary significantly among individuals, with some experiencing a steady decline and others having periods of stability. The exact cause of the disease is not fully understood, but it involves immune system attacks on the protective covering of nerves.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517336-21-00Estimated enrolment34 patientsSponsorUniversity Of Turku

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