Ongoing Clinical Trials for Status Epilepticus
Status epilepticus is a serious condition characterized by prolonged or repeated seizures without recovery between episodes. Currently, 4 clinical trials are investigating new treatment approaches for this condition, focusing on various anti-seizure medications and sedation strategies. These trials are being conducted across multiple European countries and aim to improve outcomes for patients who do not respond to standard treatments.
Clinical trial locations
- Austria
- Belgium
- Croatia
- Czechia
- Denmark
- Finland
- France
- Germany
- Hungary
- Italy
- Lithuania
- Netherlands
- Poland
- Slovakia
- Spain
Study of anti-seizure drug combination in comatose patients with status epilepticus after cardiac arrest
This trial focuses on a very specific group of patients: those who remain unconscious after their heart has stopped and been restarted, and who are experiencing continuous seizure activity detected on brain wave monitoring. The study investigates whether treating these seizures improves recovery.
Main inclusion criteria: You must be at least 18 years old and in a comatose state following an out-of-hospital cardiac arrest. Continuous brain wave monitoring must be started within 24 hours after your heart resumes beating, and this monitoring must show signs of status epilepticus. Treatment must be able to begin within 3 hours of detecting the seizure activity.
Main exclusion criteria: The trial cannot include patients under 18 years old, those with terminal illnesses, pre-existing severe brain damage, previous cardiac arrests, or known allergies to the study medications. Pregnant or breastfeeding women, patients already taking anti-seizure medications, those with severe liver or kidney problems, recent brain surgery, or drug-resistant epilepsy are also excluded.
Focus and goal: The study aims to determine whether actively treating seizures in unconscious cardiac arrest survivors leads to better recovery compared to not treating the seizures. The main measure of success is how well patients can function in their daily lives six months after the cardiac arrest. Researchers will also evaluate the cost-effectiveness of the treatment approach.
Investigational drugs: The study uses a step-by-step approach with several anti-seizure medications given through a vein, including diazepam, midazolam, lorazepam, propofol, esketamine, lacosamide, levetiracetam, and sodium valproate. These medications work by calming brain activity and stopping abnormal electrical signals that cause seizures.
Study on Treating Status Epilepticus in Seniors Using Levetiracetam and Valproate Semisodium
This trial specifically focuses on treating status epilepticus in older adults aged 65 and above. It compares two different medications to determine which is more effective in this age group.
Main inclusion criteria: You must be 65 years or older and experiencing ongoing seizures lasting at least 5 minutes, or having multiple seizures without fully regaining consciousness between them. The seizures must not respond to treatment with at least one medication from a group called benzodiazepines, which includes drugs like lorazepam, midazolam, diazepam, or clonazepam.
Main exclusion criteria: Patients younger than 65, those not experiencing seizure activity that resists benzodiazepine treatment, people unable to provide informed consent, pregnant or breastfeeding women, and those participating in other clinical trials cannot join this study.
Focus and goal: The study aims to find effective treatments for seizures in elderly patients by testing how well levetiracetam and valproate semisodium can stop seizure activity and maintain control for up to 60 minutes after treatment begins. The trial is designed to provide evidence on the best medication choices for this age group.
Investigational drugs: Two medications are being tested: levetiracetam and valproate semisodium. Both are given through an infusion directly into the bloodstream. Levetiracetam works by calming the brain and nerves to prevent abnormal electrical activity. Valproate helps stabilize electrical activity in the brain, reducing the frequency and severity of seizures.
Study on Fast Sedation with Propofol and Midazolam vs. Anti-Seizure Drug Combination for Treating Refractory Status Epilepticus in Intensive Care Patients
This trial compares two fundamentally different approaches to treating severe seizures that don’t respond to initial treatment: using sedation medications that put patients into a controlled sleep state versus using high doses of anti-seizure medications while keeping patients awake.
Main inclusion criteria: You must be an adult over 18 years old with a specific type of seizure activity called non-convulsive status epilepticus, confirmed by brain wave monitoring. The seizures must not have responded to benzodiazepines and at least one second-line anti-seizure medication such as levetiracetam, fosphenytoin sodium, or sodium valproate.
Main exclusion criteria: While the specific exclusion criteria are not fully detailed, the trial cannot include patients who are not experiencing the specific type of seizure activity being studied or those who do not meet the age requirements.
Focus and goal: The study aims to determine whether rapid sedation in an intensive care setting is more effective than high-dose anti-seizure medication treatment in a regular hospital ward. Researchers will monitor how many patients continue to have seizures after 24 hours, any new neurological problems, length of hospital stay, and survival rates.
Investigational drugs: One treatment approach uses propofol or midazolam for rapid sedation. These medications work by enhancing the activity of GABA, a neurotransmitter that calms the nervous system. The other approach uses high doses of various anti-seizure medications including levetiracetam, sodium valproate, fosphenytoin sodium, topiramate, lacosamide, and brivaracetam, all given through a vein.
Study on Ganaxolone for Patients with Refractory Status Epilepticus
This international trial tests a new medication called ganaxolone for treating severe seizures that do not respond to standard treatments. The study is being conducted across 14 European countries.
Main inclusion criteria: You must be 18 years or older with a diagnosis of status epilepticus confirmed by clinical signs and brain wave monitoring. Specifically, you must have experienced about 6 minutes of seizure activity over a 30-minute period within the hour before starting treatment, and seizure activity during the 30 minutes immediately before treatment begins. You must have already been treated with a benzodiazepine and at least one other anti-seizure medication given through a vein. Your Body Mass Index must be less than 40.
Main exclusion criteria: Patients with a history of severe allergic reactions to the study medication, poorly controlled heart conditions, pregnancy or breastfeeding, recent participation in other trials, severe liver or kidney disease, inability to follow study procedures, recent drug or alcohol abuse, current use of medications that interfere with the study treatment, poorly controlled mental health conditions, or recent major surgery cannot participate.
Focus and goal: The trial aims to evaluate whether ganaxolone, when added to standard seizure treatments, can effectively stop seizures, and to assess its safety and tolerability. The primary goal is to see if seizures stop within 30 minutes of treatment and do not return within 36 hours.
Investigational drugs: Ganaxolone is given through an intravenous line directly into the bloodstream. It works at the molecular level by enhancing the activity of GABA, a neurotransmitter that helps calm overactive brain signals leading to seizures. It is classified as a neuroactive steroid and acts on GABA-A receptors in the brain.
Summary
These four clinical trials represent diverse approaches to treating status epilepticus, ranging from specific patient populations to novel medications. A notable observation is that one trial has particularly broad international participation, being conducted across 14 European countries, while others focus on specific regions or single countries.
The trials address different aspects of the condition: one focuses exclusively on elderly patients aged 65 and above, another targets the unique situation of cardiac arrest survivors, and two investigate treatment-resistant cases. There is considerable interest in testing various anti-seizure medications, with levetiracetam, valproate, and midazolam appearing across multiple trials. One trial introduces ganaxolone, a newer investigational drug that works differently from traditional anti-seizure medications.
The trials also reflect different treatment philosophies, with one study directly comparing sedation approaches versus anti-seizure medication strategies. This diversity in trial design and medication approaches suggests ongoing efforts to find the most effective treatment methods for different patient groups experiencing this serious condition.
