Brain bleed breakdown: could a common seizure pill boost recovery?
NCT ID NCT07336992
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times
Summary
This study tests whether giving the seizure medicine levetiracetam right after a brain bleed (intracerebral hemorrhage) can prevent seizures and improve long-term recovery. About 580 adults will receive either the drug or a placebo for up to 7 days, and their level of disability will be checked 6 months later. The goal is to see if preventing early seizures leads to better function and quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 580 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2030
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: * Age ≥ 18 years * Spontaneous (non-traumatic) supratentorial intracerebral haemorrhage diagnosed by brain CT or MRI * Onset of neurologic symptoms within 24 hours * NIHSS score on admission ≤ 25 * Informed consent given by the patient or his/her impartial witness * Patients benefiting from a social insurance system or a similar system * For women of childbearing age, use of highly effective contraceptive method, which will be continued until the end of relevant systemic exposure of the treatment (i.e 56 hours after end of treatment). Exclusion Criteria: * Intracerebral haemorrhage known or suspected by study investigator to be secondary to trauma, vascular malformation, haemorrhagic transformation of ischaemic stroke, or tumour * Current use of antiseizure drugs or history of epilepsy * Patients with inaugural seizures at the onset of symptoms associated with intracerebral hemorrhage * Patients with QTc prolongation * Patients who have been part of a clinical study involving another investigational product in the previous 30 days or within 5 half-lives of the other investigational product prior to Screening, whichever is longer, or participant is currently receiving an investigational product * Severe renal insufficiency (creatinine clearance \< 30 ml/min) * Pregnancy or breastfeeding * Previous history of severe depression or psychotic disorder or suicidal attempt * Known terminal illness * Known allergy or hypersensitivity to levetiracetam or other pyrrolidone derivatives, or any of the excipients * Known allergy or hypersensitivity to microcrystalline cellulose or lactose * Patients taking probenecid, methotrexate or macrogol * Being under legal protection * Patients with seizures occurring between the inclusion of the patient and the start of the treatment * Positive pregnancy test at inclusion for women of childbearing age
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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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Hospices Civils de Lyon
Bron, 69500, France
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