Diroximel Fumarate for Intracerebral haemorrhage | Stroke

Inclusion criteria

• {"criterion_text":"- Patients 18 years or older (no upper age limit)\n- Patients admitted for a first-ever or recurrent symptomatic supratentorial spontaneous ICH confirmed by brain imaging\n- Administration of study treatment no later than 48 hours after symptom onset or since last seen without neurological deficit\n- Written consent obtained\n- Patient with social insurance in France\n- Patient willing to comply with all study procedures and duration"}

Exclusion criteria

• {"criterion_text":"- Massive ICH for Investigational medicinal product seems futile (hematoma volume is estimated > 60ml)\n- Patients unable to swallow\n- Severe pre-ICH dependency (modified Rankin score of 5)\n- Life expectancy < 1 year related to comorbidities\n- Late-stage organ (acute cardiac, renal or hepatic failure)\n- Decision already taken for palliative (end of life) care with withdrawal of active treatment\n- Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done)\n- Adults who are deprived of their liberty by judicial or administrative decision\n- Severe coma (Glasgow Coma Scale <6)\n- Pure intraventricular hemorrhage\n- ICH suspected to result from a preceding trauma, an identified intracranial vascular malformation, venous thrombosis, tumor or hemorrhagic transformation within an infarct\n- Patient planned for surgical evacuation of ICH (Evacuation, Decompressive hemicraniectomy, External ventricular drain)\n- Patient with a known indication for DRF treatment (e.g. multiple sclerosis) or any other NrF2 agonist (dimethyl fumarate; Tecfidera)\n- Patient with contraindication to DRF: patients with known hypersensitivity to DRF, or to any of the excipients of VUMERITY; patients taking dimethyl fumarate)\n- Severe lymphopenia at admission (lymphocyte counts < 0.5 x 109/L)\n- Medical history of progressive multifocal leukoencephalopathy"}

Primary endpoints

• {"endpoint_text":"- Absolute volume of PHO assessed at 8 ± 1 days with brain non-contrast CT (NCCT) scan.","definition_or_measurement_approach":"Measured by brain non-contrast CT (NCCT) scan at day 8 ± 1 days to assess absolute volume of peri-haematoma oedema (PHO)."}

Secondary endpoints

• {"endpoint_text":"- Functional outcome: global disability assessed by overall distribution of mRS score at 6 months (end of follow-up) (shift analysis)","definition_or_measurement_approach":"Measured by distribution (shift analysis) of modified Rankin Scale (mRS) score at 6 months (end of follow-up)."}
• {"endpoint_text":"- Safety outcome: The rate of severe adverse events (see chapter 10 “Safety Assessment”) occurring between the date of randomization and the end of follow-up (six-month visit).","definition_or_measurement_approach":"Rate of severe adverse events occurring between randomization and end of follow-up (six-month visit), as defined in study safety assessment procedures."}

France

Earliest CTIS Part Ii Submission Date

23-02-2026

Latest Decision Or Authorization Date

26-02-2026

Processing Time Days

3

Number Of Sites

10

Number Of Participants

192

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Lille

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France