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 study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Ckaeya Hnqpxscuinu Usosintxxcpfu Dt Debdb	Dijon	France
Cpoctr Havyhyavzjg Rtxzzpnt Uhdsxlhtsqtzw Di Tbziu	Tours	France
Csqc Do Nultq	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.02.2026

Trial locations

Investigated drugs:

Diroximel Fumarate

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.

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 ID:

2025-522687-33-00

Protocol code:

2024_0474

Trial Phase:

Therapeutic confirmatory (Phase III)

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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.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?