Brain bleed breakdown: could a common seizure pill boost recovery?

NCT ID NCT07336992

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
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Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
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Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 580 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Hospices Civils de Lyon

    Bron, 69500, France

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