Ketamine for Status Epilepticus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether using ketamine earlier can stop seizures in patients with refractory status epilepticus, a condition where seizures resist typical treatments. It tests two approaches: starting ketamine (an anesthetic) simultaneously with midazolam or after midazolam. The trial seeks adults with ongoing seizures unresponsive to other medications. Participants should not have certain medical conditions, such as high blood pressure concerns, or allergies to ketamine. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for ketamine?
Research has shown that ketamine is generally safe for treating seizures in status epilepticus, a severe and ongoing seizure condition. One study found that ketamine helped stop seizures in many patients, with about 94% experiencing better seizure control. This means their seizures either stopped completely or were reduced by more than half.
In another study, most patients found ketamine effective and safe. The research indicates that ketamine is well-tolerated, with many patients experiencing a significant drop in seizures without major side effects.
These findings suggest that ketamine can be a reliable option for managing difficult-to-treat seizures, with a good safety profile.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for status epilepticus, which usually involve anesthetics like propofol or barbiturates, ketamine offers a unique approach by acting on the brain's NMDA receptors. Researchers are excited about ketamine because it provides a potential alternative mechanism of action that could be beneficial when other treatments fail. Additionally, ketamine can be administered early alongside midazolam or later after midazolam, offering flexibility in treatment timing and potentially improving patient outcomes. This adaptability and novel action make ketamine a promising option for managing this severe and persistent seizure condition.
What evidence suggests that ketamine might be an effective treatment for status epilepticus?
Research has shown that ketamine can help stop seizures in people with hard-to-treat status epilepticus (RSE). Several studies have found that ketamine can quickly end seizures and shorten their duration. One study showed that ketamine stopped seizures in 98.2% of patients without recurrence. Another study found that ketamine stopped seizures in 71.4% of patients and was well-tolerated. In this trial, participants will receive ketamine either as an early intervention, initiated simultaneously with midazolam, or as a late intervention, started after midazolam. Ketamine works differently from other seizure medications by affecting NMDA receptors in the brain, which might also help protect the brain. Overall, ketamine has proven to be a safe and effective treatment for seizures that are difficult to control.12678
Who Is on the Research Team?
Syed O Shah, MD
Principal Investigator
Thomas Jefferson University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with refractory status epilepticus, a severe form of seizure that doesn't stop after first-line treatments like lorazepam and one second-line medication. It's not for pregnant or incarcerated individuals, those allergic to ketamine, patients where high blood pressure is risky, or if the seizures are psychogenic non-epileptic, focal motor in nature, or have lasted more than 24 hours.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either early or late ketamine infusion along with midazolam for seizure control
Follow-up
Participants are monitored for safety and effectiveness after treatment, including functional outcomes at discharge, 3 months, and 6 months
What Are the Treatments Tested in This Trial?
Interventions
- Ketamine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thomas Jefferson University
Lead Sponsor