NCT07275515 DIROXIMEL FUMARATE TO REDUCE PERIHAEMATOMAL OEDEMA IN INTRACEREBRAL HAEMORRHAGE: DOUBLE BLIND RANDOMIZED CLINICAL TRIAL
| NCT ID | NCT07275515 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Lille |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2026-05-19 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 192 participants in total. It began in 2026-05-19 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Spontaneous intracerebral haemorrhage (ICH) is a life-threatening condition, still devoided of specific treatment. Peri-haematomal oedema (PHO) develops in the ensuing days after ICH onset and worsens functional outcome. Hence, PHO is a promising therapeutic target but until now there is no specific treatment for PHO. The occurrence and growth of PHO is mainly mediated by inflammation. We hypothesize that a modulation of inflammation is effective in reducing PHO growth, therefore improving the functional outcome of ICH patients. From animal studies to human post-mortem studies, our team has demonstrated a key role for erythroid-related nuclear factor 2 (Nrf2) in PHO. Indeed, this transcription factor promotes the protective effect of inflammation: Nrf2 activation enhances antioxidant defenses and increases rates of blood resorption. Therefore, Nrf2 emerges as a promising and innovative therapeutic target. Taking into account the prolonged time interval between de novo drug discovery and use in clinical practice, drug repurposing is an interesting option for the unmet clinical need of reducing PHO. We chose Diroximel Fumarate (DRF) which is a safe and effective Nrf2 activator widely used in multiple sclerosis (dimethyl fumarate is on the market since 2013, and DRF since 2019) to modulate inflammation and to establish the efficacy of Nrf2 activation in reducing PHO growth and, ultimately, in improving the functional prognosis after ICH.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07275515 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07275515 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07275515 currently recruiting?
Yes, NCT07275515 is actively recruiting participants. Contact the research team at laurent.puy@univ-lille.fr for enrollment information.
Where is the NCT07275515 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT07275515 clinical trial?
NCT07275515 is sponsored by University Hospital, Lille. The trial plans to enroll 192 participants.
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