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Study on Treating Status Epilepticus in Seniors Using Levetiracetam and Valproate Semisodium

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the treatment of status epilepticus in individuals aged 65 and older. Status epilepticus is a serious condition where a person experiences a prolonged seizure or multiple seizures without regaining full consciousness in between. The study aims to find effective treatments for this condition in the elderly population. Two medications are being tested: levetiracetam and valproate semisodium. These medications are administered through an infusion, which means they are given directly into the bloodstream.

The purpose of the study is to gather evidence on how well these medications can stop the seizures and control epileptic activity within 60 minutes of starting the treatment. Participants in the study will receive either levetiracetam, valproate semisodium, or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers know which treatment is being given, to ensure unbiased results.

Throughout the study, participants will be closely monitored to assess the effectiveness of the treatments. The trial will help determine which medication is more effective in managing status epilepticus in the elderly, providing valuable information for future treatment options. The study is expected to continue until November 2026.

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

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose, which is to find effective treatments for a condition called status epilepticus in individuals aged 65 and older.

    You will be asked to provide consent to participate in the study, ensuring you understand the procedures and any potential risks involved.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying that you have experienced ongoing seizures lasting at least 5 minutes or multiple seizures without full recovery of consciousness.

    Your medical history and current health status will be reviewed to ensure you meet the study criteria.

  3. Step 3

    Treatment administration

    You will receive one of two medications: levetiracetam or valproate semisodium. These medications will be administered through an infusion, which means they will be given directly into your bloodstream.

    The goal is to stop the seizures and maintain control of epileptic activity for up to 60 minutes after the treatment begins.

  4. Step 4

    Monitoring and follow-up

    After receiving the medication, your condition will be closely monitored to assess the effectiveness of the treatment.

    You will be observed for any changes in your seizure activity and overall health during this period.

  5. Step 5

    Conclusion of participation

    Once the monitoring period is complete, your participation in the trial will conclude.

    You will receive information about any further steps or follow-up care if necessary.

Who can join the trial?

8 criteria

  • Must be an adult who is 65 years or older.
  • Must have ongoing convulsive status epilepticus (SE), which means having a seizure lasting 5 minutes or more, or having two or more seizures without fully waking up in between.
  • Can also have nonconvulsive status epilepticus (NCSE), which is a type of seizure that doesn't involve convulsions but shows specific patterns on an EEG (a test that measures brain activity).
  • The condition must not respond to treatment with at least one of the following medications:
    • Lorazepam 2 mg given through a vein (i.v.)
    • Midazolam 5 mg given through a vein (i.v.), in the cheek (buccal), in the nose (intranasal), or in the muscle (i.m.)
    • Diazepam 5 mg given through a vein (i.v.) or rectally
    • Clonazepam 1 mg given through a vein (i.v.)
    • Both men and women can participate.

Who cannot join the trial?

6 criteria

  • Patients who are not 65 years or older cannot participate.
  • Patients who do not have a condition called status epilepticus that does not respond to a type of medication called benzodiazepines cannot participate. Status epilepticus is a condition where a person has a long-lasting seizure or many seizures close together without recovering in between.
  • Patients who have any other medical conditions that might interfere with the study cannot participate.
  • Patients who are unable to give their own consent to participate in the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
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Investigated drugs

  • Levetiracetam

    is a medication used to help control seizures. It works by calming the brain and nerves, which can help prevent the abnormal electrical activity that causes seizures. In this trial, it is being tested to see how effective it is in treating seizures in elderly patients.

  • Valproate

    is another medication used to treat seizures. It helps to stabilize electrical activity in the brain, which can reduce the frequency and severity of seizures. This trial is examining its effectiveness in elderly patients who are experiencing seizures.

  • Lorazepam

    is a medication that is often used to quickly stop seizures. It works by calming the brain and nerves, providing fast relief from seizure activity. In this trial, it is being used to see how well it works in elderly patients with seizures.

What is already known about the treatment

  • Benzodiazepines

    Benzodiazepines are given as an injection directly into a vein or into a muscle, or as a rectal solution, and they are used as the first-line treatment for epileptic seizures. In medicine they are recognized as the standard treatment for situations in which seizures last longer than a few minutes, although in some cases resistance may develop, meaning that they stop working. These medicines act by enhancing the effect of a natural substance in the brain called GABA, which dampens nerve activity and helps stop the uncontrolled electrical discharges that cause seizures. They belong to the group of sedatives and anxiolytics, which calm the nervous system and are used to treat anxiety, insomnia and epilepsy.

  • Levetiracetam

    Levetiracetam is given in the form of tablets, an oral solution or an infusion into a vein, and it is a modern antiepileptic drug used to treat various types of epileptic seizures, including situations in which standard treatment does not work. In current medicine it is recognized as an effective alternative for the treatment of established status epilepticus, especially in older patients, in whom its safety and effectiveness are being studied. It acts by binding to a specific protein in nerve cells called SV2A, thereby modulating the release of neurotransmitters and stabilizing electrical activity in the brain. It belongs to the group of new-generation antiepileptic drugs with a favorable safety profile.

  • Valproate

    Valproate is given in the form of tablets, capsules or an infusion into a vein, and it is one of the oldest and most widely used medicines for treating epilepsy and bipolar disorder. In clinical practice it is used as an alternative treatment for status epilepticus when first-line drugs are not effective, and its use in older patients continues to be studied. It acts through several mechanisms at once – it increases the level of GABA in the brain, blocks sodium channels in nerve cells and affects other systems, thereby stabilizing brain activity. It belongs to the group of broad-spectrum anticonvulsants.

Investigated diseases

Status Epilepticus – Status epilepticus is a condition where a person experiences a prolonged seizure lasting more than five minutes or has multiple seizures without regaining full consciousness between them. It can be convulsive, involving full-body muscle contractions, or nonconvulsive, where the person may appear confused or have subtle twitching. This condition can occur in individuals with a history of epilepsy or as a new onset in those without prior seizures. The progression involves continuous or repeated seizure activity that can lead to significant neurological impairment if not controlled. It is considered a medical emergency due to the risk of prolonged brain activity. In older adults, it may present differently and requires careful monitoring.
Trial detailsLast updated 30 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-516634-35-00Protocol codeToSEEEstimated enrolment132 patientsSponsorUniversitaet Leipzig

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