Could a common MS drug help stroke patients? new trial begins
NCT ID NCT07275515
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Lille
RECRUITINGLille, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Effects of transcranial direct current stimulation and pelvic proprioceptive neuromuscular facilitation on trunk control, balance and functional mobility in stroke patients
- Correlation of visual and motor deficits in stroke patients
- Pilot study on the effects induced by an electromyographic-controlled functional electrical stimulator (FitFES) for upper limb rehabilitation in post-stroke patients
- Brazilian version of a behavior change intervention to support healthy lifestyle adoption after stroke - iVIDAVC: protocol for a pilot randomized study
- Determination of efficacy of sustained motor contraction generated using StimWave peripheral nerve stimulator
- Can a PET tracer reveal hidden brain inflammation?