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Study evaluating the effect of levetiracetam on recovery in patients with intracerebral haemorrhage

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates the effectiveness of using a preventative medication to improve long-term health outcomes for individuals experiencing an intracerebral haemorrhage, which is a type of stroke caused by bleeding inside the brain. The treatment being studied is levetiracetam, an antiseizure drug used to prevent seizures, which are sudden, uncontrolled electrical disturbances in the brain. The study aims to determine if giving this medication early can improve a person's ability to perform daily activities following the bleeding event.

Participants in this trial will be assigned to receive either levetiracetam, which may be given as film-coated tablets for oral use or as a solution for infusion through a vein, or a placebo. This is a randomised study, meaning participants are placed into groups by chance, and it is double-blind, so neither the participants nor the researchers know which treatment is being administered during the process. The study will involve monitoring participants over several months to observe how the treatment affects their overall health and independence.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Administration of medication

    During the acute phase, which is the early period following an intracerebral haemorrhage (bleeding within the brain), medication is administered.

    The test medication, known as levetiracetam, is provided either as an intravenous infusion (medicine delivered directly into a vein) at a dose of 100 mg/ml or as oral tablets at a dose of 250 mg.

    Instead of the active medicine, a placebo (a substance with no active medicinal effect) may be administered via infusion or as a tablet.

  2. Step 2

    Early clinical assessments

    Within 72 hours after starting the trial, assessments are conducted to measure the NIHSS score (a scale used to evaluate the severity of stroke symptoms) and to check the volume of the brain bleed and any midline shift (displacement of brain structures) through brain imaging.

    The number of clinical seizures (sudden, uncontrolled electrical disturbances in the brain) occurring within the first 72 hours is recorded.

  3. Step 3

    One month follow-up

    At the one month mark, the frequency of side effects related to the treatment is monitored.

    Information regarding the occurrence of pneumonia (an infection in the lungs) and delirium (a state of sudden confusion) is collected.

    Levels of anxiety and depression are evaluated using a standardized scale.

    The mortality rate (the rate of death) is recorded.

  4. Step 4

    Six month follow-up

    At 6 months, a functional status assessment is performed using the modified Rankin Scale (a tool used to measure the degree of disability or dependence) through a face-to-face or remote interview conducted by a specialist.

    The NIHSS score is re-evaluated to track changes.

    cognitive impairment is assessed using the MoCA (a test to check mental functions like memory and attention) and FACT-Cog (a tool to evaluate cognitive complaints).

    quality of life is measured using the EQ-5D-5L scale.

    The frequency of seizures, side effects, anxiety, and depression is monitored.

    The mortality rate is recorded.

  5. Step 5

    Twelve month follow-up

    At 12 months, the modified Rankin Scale is used again to assess functional status.

    The number of seizures is recorded.

    quality of life is measured via the EQ-5D-5L scale.

    The mortality rate is recorded.

Who can join the trial?

8 criteria

  • You must be 18 years of age or older.
  • You must have had a spontaneous intracerebral haemorrhage, which means a bleed inside the brain that happened on its own and was not caused by an injury or accident.
  • This bleeding must have occurred in the supratentorial area, which is the upper part of the brain located above a dividing membrane.
  • The bleeding must have been confirmed by a CT scan (a type of X-ray used to see inside the body) or an MRI (a scan that uses strong magnets to create detailed images of the brain).
  • Your neurologic symptoms, which are changes in how your body or brain functions, must have started within 24 hours of the event.
  • Your NIHSS score, which is a tool used by doctors to measure the severity of a stroke based on physical symptoms, must be 25 or less at the time you are admitted to the hospital.
  • You or an impartial witness must provide informed consent, which means you officially agree to participate after understanding all the details of the study.
  • You must be covered by social insurance or a similar type of health coverage system.

Who cannot join the trial?

13 criteria

  • You cannot participate if your intracerebral haemorrhage (bleeding inside the brain) was caused by an injury, a problem with a blood vessel, a brain tumor, or if it happened because a previous stroke turned into a bleed.
  • You cannot participate if you had your very first seizure (an uncontrolled electrical disturbance in the brain) at the same time your brain bleeding started.
  • You cannot participate if you have QTc prolongation, which is a condition where the electrical activity of your heart takes longer than normal to reset between beats.
  • You cannot participate if you have taken another experimental medicine within the last 30 days or within a specific timeframe required for that drug to leave your system.
  • You cannot participate if you are currently taking probenecid, methotrexate, or macrogol (medications used for different health conditions).
  • You cannot participate if you are currently taking antiseizure drugs (medicines used to prevent seizures) or if you have a history of epilepsy (a long-term brain disorder that causes frequent seizures).
  • You cannot participate if you have severe renal insufficiency, which means your kidneys are not working well enough to filter your blood properly.
  • You cannot participate if you are pregnant or breastfeeding.
  • You cannot participate if you have a history of severe depression, a psychotic disorder (a mental condition that affects your ability to think clearly or perceive reality), or if you have attempted suicide.
  • You cannot participate if you have a known terminal illness (a disease that cannot be cured and is expected to lead to death).
  • You cannot participate if you are allergic to Levetiracetam, other pyrrolidone derivatives (a specific group of chemical compounds), or any of the excipients (inactive ingredients used to make a pill).
  • You cannot participate if you are allergic to microcrystalline cellulose or lactose (a type of sugar found in milk).
  • You cannot participate if you are under legal protection.
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Investigated drugs

Levetiracetam is an anti-seizure medication used in this study to prevent seizures in patients who have experienced bleeding in the brain.

What is already known about the treatment

Levetiracetam - This medication is an anticonvulsant used to prevent and treat seizures, commonly administered either as a tablet swallowed by mouth or as a liquid solution through an intravenous line. It is a well-established treatment in medical practice for managing various types of epilepsy and preventing seizure activity. At a molecular level, it works by binding to a specific protein in the brain to help stabilize nerve cell activity and prevent the uncontrolled electrical surges that cause seizures.

Investigated diseases

Intracerebral haemorrhage - This condition occurs when a blood vessel ruptures and bleeds directly into the brain tissue. The accumulation of blood within the brain can increase pressure and damage surrounding cells. As the bleeding continues, it may cause a shift in the brain's normal structure. This process can lead to various changes in physical and mental functions. The severity often depends on the location and amount of blood released.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515663-59-00Protocol code69HCL23_0934Estimated enrolment580 patientsSponsorHospices Civils De Lyon

sourced from the EU Clinical Trials Register and site verification

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