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DIROXIMEL FUMARATE TO REDUCE PERIHAEMATOMAL OEDEMA IN INTRACEREBRAL HAEMORRHAGE: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL
EU CTIS ID: 2025-522687-33-00
What this study is testing
To demonstrate the efficacy of Diroximel Fumarate (DRF) as compared with placebo in reducing Peri-Haematoma Oedema (PHO) at day 8 in patients with spontaneous intracerebral haemorrhage (ICH).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients 18 years or older (no upper age limit)
- Patients admitted for a first-ever or recurrent symptomatic supratentorial spontaneous ICH confirmed by brain imaging
- Administration of study treatment no later than 48 hours after symptom onset or since last seen without neurological deficit
- Written consent obtained
- Patient with social insurance in France
- Patient willing to comply with all study procedures and duration
You likely can't join if
- Massive ICH for Investigational medicinal product seems futile (hematoma volume is estimated > 60ml)
- Patients unable to swallow
- Severe pre-ICH dependency (modified Rankin score of 5)
- Life expectancy < 1 year related to comorbidities
- Late-stage organ (acute cardiac, renal or hepatic failure)
- Decision already taken for palliative (end of life) care with withdrawal of active treatment
See the full eligibility criteria
- Patients 18 years or older (no upper age limit)
- Patients admitted for a first-ever or recurrent symptomatic supratentorial spontaneous ICH confirmed by brain imaging
- Administration of study treatment no later than 48 hours after symptom onset or since last seen without neurological deficit
- Written consent obtained
- Patient with social insurance in France
- Patient willing to comply with all study procedures and duration
- Massive ICH for Investigational medicinal product seems futile (hematoma volume is estimated > 60ml)
- Patients unable to swallow
- Severe pre-ICH dependency (modified Rankin score of 5)
- Life expectancy < 1 year related to comorbidities
- Late-stage organ (acute cardiac, renal or hepatic failure)
- Decision already taken for palliative (end of life) care with withdrawal of active treatment
- Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done)
- Adults who are deprived of their liberty by judicial or administrative decision
- Severe coma (Glasgow Coma Scale <6)
- Pure intraventricular hemorrhage
- ICH suspected to result from a preceding trauma, an identified intracranial vascular malformation, venous thrombosis, tumor or hemorrhagic transformation within an infarct
- Patient planned for surgical evacuation of ICH (Evacuation, Decompressive hemicraniectomy, External ventricular drain)
- Patient with a known indication for DRF treatment (e.g. multiple sclerosis) or any other NrF2 agonist (dimethyl fumarate; Tecfidera)
- Patient with contraindication to DRF: patients with known hypersensitivity to DRF, or to any of the excipients of VUMERITY; patients taking dimethyl fumarate)
- Severe lymphopenia at admission (lymphocyte counts < 0.5 x 109/L)
- Medical history of progressive multifocal leukoencephalopathy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.