Could a common MS drug help stroke patients? new trial begins

NCT ID NCT07275515

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether Diroximel Fumarate, a drug already used for multiple sclerosis, can reduce harmful brain swelling that often occurs after a hemorrhagic stroke. The swelling, called perihematomal edema, can worsen recovery. The trial will enroll 192 adults who have had a stroke, giving them either the drug or a placebo for 21 days. Researchers will measure brain swelling on CT scans and check functional outcomes after 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Diroximel Fumarate
What this could lead to
If it works, this could point toward a new treatment to reduce brain swelling and improve recovery after a hemorrhagic stroke.
What could go wrong
This is an early Phase 2 trial with only 192 people, so results may not confirm benefit. The drug is repurposed from multiple sclerosis, and its effect on stroke-related swelling is unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 192 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients 18 years or older (no upper age limit) 2. Patients admitted for a first-ever or recurrent (occurred more than 1 year before) symptomatic supratentorial spontaneous ICH confirmed by brain imaging 3. Administration of study treatment no later than 48 hours after symptom onset or since last seen normal 4. Written consent obtained 5. Patient with social insurance in France 6. Patient willing to comply with all study procedures and duration Exclusion Criteria: 1. Massive ICH for Investigational medicinal product seems futile (hematoma volume is estimated \> 60ml) 2. Severe coma (Glasgow Coma Scale \<6) 3. Pure intraventricular hemorrhage 4. ICH suspected to result from a preceding trauma, an identified intracranial vascular malformation, venous thrombosis, tumor or hemorrhagic transformation within an infarct 5. Patient planned for surgical evacuation of ICH before randomization (Evacuation, Decompressive hemicraniectomy, External ventricular drain) 6. Patient with a known indication for DRF treatment (e.g. multiple sclerosis) or any other NrF2 agonist (dimethyl fumarate; Tecfidera) 7. Patient with contraindication to DRF: patients with known hypersensitivity to DRF, or to any of the excipients of VUMERITY (patients taking dimethyl fumarate) 8. Severe lymphopenia at admission (lymphocyte counts \< 0.5 x 109/L) 9. Medical history: Suspected or confirmed of progressive multifocal leukoencephalopathy 10. Severe swallowing disorder and/or nasogastric tube required 11. Severe pre-ICH dependency (modified Rankin score of 5) 12. Life expectancy \< 1 year related to comorbidities 13. Late-stage organ (acute cardiac, renal or hepatic failure) 14. Decision already taken for palliative (end of life) care with withdrawal of active treatment 15. Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done) 16. Adults who are deprived of their liberty by judicial or administrative decision

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • CHU de Lille

    RECRUITING

    Lille, France

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