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A study to evaluate the use of diroximel fumarate to reduce brain swelling in patients with a stroke caused by bleeding in the brain.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Intracerebral Hemorrhage, which is a type of Stroke that occurs when a blood vessel in the brain bursts and causes bleeding inside the brain tissue. A common complication following this event is Perihematomal Oedema, which refers to swelling and fluid buildup in the brain area surrounding the site of the bleeding. The purpose of this study is to evaluate if the medication diroximel fumarate can help reduce this swelling.

Participants in the trial will be assigned to receive either diroximel fumarate or a placebo. The study is designed so that neither the participants nor the researchers know which treatment is being administered. During the course of the study, the amount of swelling will be monitored using a computed tomography scan, which is a medical imaging test that uses X-rays to create detailed pictures of the brain. The progress of the participants will be followed for six months to observe long-term effects and safety.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and treatment

    Assignment to one of two groups occurs: receiving either the test medication or a placebo (an inactive substance that looks and tastes the same as the medicine).

    The test medication is diroximel fumarate, provided in 924 mg doses via oral capsules.

  2. Step 2

    Early assessment

    A brain scan (non-contrast CT scan) is performed approximately 8 days after starting the medication to measure the volume of peri-haematoma oedema, which is the swelling around the area of bleeding in the brain.

  3. Step 3

    Follow-up period

    Monitoring for safety and side effects continues from the time of group assignment until the final visit.

    A six-month follow-up visit is conducted to assess functional outcome, which refers to the level of disability or ability to perform daily activities.

Who can join the trial?

10 criteria

  • You must be 18 years of age or older.
  • You must have had a spontaneous intracerebral haemorrhage, which is a type of stroke caused by bleeding inside the brain that happens on its own without an injury.
  • The bleeding must have occurred in the supratentorial area, which is the upper part of the brain located above a specific structure called the tentorium.
  • The bleeding must have been confirmed by brain imaging, such as a scan that takes pictures of the inside of the head.
  • The bleeding can be your first-ever event or a recurrent one, meaning it has happened before.
  • The bleeding must be symptomatic, meaning it is causing noticeable symptoms or physical changes.
  • You must receive the study treatment within 48 hours of when your symptoms first started or from the last time you were seen behaving normally without any brain-related issues.
  • You must provide written consent, which means signing a formal document agreeing to participate.
  • You must have social insurance in France.
  • You must be willing to follow all the study procedures and complete the entire length of the study.

Who cannot join the trial?

16 criteria

  • Having a very large intracerebral hemorrhage, which is a type of bleed inside the brain, where the blood clot is estimated to be larger than 60ml.
  • Being unable to swallow food or liquids safely.
  • Having a high level of dependency before the brain bleed, meaning the person required significant help with daily activities.
  • Having an expected life expectancy of less than one year due to other existing health problems.
  • Experiencing organ failure, which means the heart, kidneys, or liver are not working properly.
  • Having already decided to enter palliative care, which is medical care focused on providing comfort rather than curing a disease, often involving the stopping of active treatments.
  • Being pregnant, breastfeeding, or being a woman of childbearing age who is not using effective contraception (methods used to prevent pregnancy).
  • Being an adult who is not free to make their own decisions due to judicial or administrative decisions.
  • Being in a severe coma, which is a state of prolonged unconsciousness where a person cannot be awakened.
  • Having a pure intraventricular hemorrhage, which is a type of bleeding that occurs specifically in the fluid-filled spaces of the brain.
  • Having a brain bleed that is suspected to be caused by an injury, a vascular malformation (an abnormality in the blood vessels), a blood clot in a vein, a tumor, or a bleed that happened inside an area of the brain previously damaged by a stroke.
  • Having a scheduled surgery to remove the blood from the brain or to relieve pressure inside the skull.
  • Already having a medical reason to take the study medication, such as multiple sclerosis, or taking other similar medications.
  • Having an allergy or hypersensitivity to the study drug or any of its inactive ingredients.
  • Having severe lymphopenia, which means having a very low count of lymphocytes (a specific type of white blood cell that helps the body fight infection).
  • Having a medical history of progressive multifocal leukoencephalopathy, which is a rare and serious disease that affects the brain's white matter.
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Investigated drugs

Vumerity is an oral medication being tested to see if it can help reduce swelling around a blood clot in the brain following a spontaneous brain bleed.

What is already known about the treatment

  • Diroximel fumarate

    This medication is taken by mouth in the form of hard capsules that are designed to resist stomach acid. It is currently an approved medicine used to treat certain nervous system conditions, but in this study, it is being investigated for its ability to reduce brain swelling after a stroke caused by bleeding. The drug works at a molecular level by helping to manage the body's inflammatory response and protecting cells from damage. It is classified as an immunomodulator that helps regulate the immune system.

  • Placebo

    This is an inactive substance administered in the same way as the active medication to ensure the study remains fair and unbiased. It has no medicinal ingredients and is used as a comparison tool to see if the real drug actually works. It is widely used in medical research to provide a baseline for evaluating the effectiveness of new treatments. Because it contains no active molecules, it has no biological effect on the body.

Investigated diseases

Intracerebral haemorrhage - This condition occurs when a blood vessel within the brain ruptures and leaks blood into the surrounding brain tissue. The accumulating blood creates a collection known as a haematoma. As the blood spreads, it often causes swelling and fluid buildup in the brain area around the site of the bleed. This process can lead to increased pressure within the skull. The progression involves the initial bleeding event followed by inflammatory responses and swelling in the neural tissue.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522687-33-00Protocol code2024_0474Estimated enrolment192 patientsSponsorCentre Hospitalier Universitaire De Lille

sourced from the EU Clinical Trials Register and site verification

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