Scientists in the US have received an initial $9.3 million from the National Institutes of Health for a $30 million clinical trial into the use of ketamine for status epilepticus in adults and children.
Dr Jaideep Kapur (pictured), neurologist at the UVA Brain Institute and study lead said the trial is due to start in the summer. Additional funding will be provided based on the study’s progress and the team expect it to last around 4.5 years.
Previous studies have looked into the use of the powerful anaesthetic ketamine for the prolonged epileptic seizures. A study from 2022 found that ketamine had a 60% success rate, while a 2024 study from Spain found a “good response” in 57% of patients.
SRSE is status epilepticus that continues or recurs for 24 hours or more after third-line treatment has been given.
Improve treatment guidelines
In the latter, study authors concluded that the presence of super-refractory status epilepticus (SRSE) and how quickly ketamine was administered was linked to its effectiveness.
Now, University of Virginia (UVA) Brain Institute and School of Medicine researchers are looking to investigate whether adding ketamine to existing status epilepticus treatment would stop these seizures in more patients than current treatment alone.
Status epilepticus is usually treated with benzodiazepines. But this first-line treatment is not successful in up to a third of patients. Refractory status epilepticus (where the seizure does not stop with this treatment) can be treated with levetiracetam, fosphenytoin (phenytoin in the UK) and valproate, but research has found those are only effective in half of cases.
The trial is looking to initiate ketamine as second-line therapy, if benzodiazepines have failed. It will be given alongside levetiracetam, which is standard second-line treatment, Dr Kapur said.
UVA said the trial will particularly focus on the outcomes in children aged over one year, expecting around a third of participants to be aged 1-17 years. Dr Kapur said: “Ketamine has been used in children with refractory or super refractory status epilepticus. We plan to use it in established status epilepticus.”
Dr Kapur said the team wants to assess the effectiveness of ketamine in these cases. “Our hope is that this trial can improve treatment guidelines for patients suffering from these dangerous seizures,” he said.
The trial will be randomised and double blinded, and will evaluate the effectiveness of adding 1mg or 3mg of ketamine to patients’ status epilepticus treatment. It is expecting to enrol “hundreds of participants” and run over the next “several years” across around 60 sites.
UVA said the trial will particularly focus on the outcomes in children aged over one year, expecting around a third of participants to be aged 1-17 years.
The study, Ketamine add-on therapy for the Established Status Epilepticus Treatment Trial (KESETT), follows the ESETT trial (Established Status Epilepticus Treatment Trial).
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