Diroximel fumarate to reduce swelling around a brain bleed

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled phase 2 multicenter trial of diroximel fumarate (DRF) versus placebo in adults with supratentorial spontaneous intracerebral hemorrhage. Study treatment is given no later than 48 hours after symptom onset and patients are followed with brain imaging to measure peri‑hematomal edema growth and with clinical scales for functional outcome. Key exclusions include very large hematomas, severe coma, pure intraventricular hemorrhage, secondary causes such as trauma or vascular malformation, and planned surgical evacuation. The intervention aims to modulate inflammation via Nrf2 activation to limit edema and promote blood resorption.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de Lille
  Lille, France Recruiting

Study contacts

• Study coordinator: Laurent PUY
• Email: laurent.puy@univ-lille.fr
• Phone: 0320446814

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.