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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Medicine Greifswald	Greifswald	Germany
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Klinikum Dortmund gGmbH	Dortmund	Germany
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Carl-von-Basedow-Klinikum Saalekreis gGmbH	Merseburg	Germany
Klinikum Kassel GmbH	Kassel	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Klinikum Osnabrück GmbH	Osnabrück	Germany
Evangelische Krankenhausstiftung Oldenburg	Oldenburg In Holstein	Germany
Uageemynphfrzdnsuylox Eqrpe Ads	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	06.02.2021

Trial locations

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.

Investigated diseases:

Status epilepticus

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 ID:

2024-516634-35-00

Protocol code:

ToSEE

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?