In a significant development for epilepsy treatment, researchers at the University of Virginia are launching a $30 million clinical trial to investigate whether ketamine could save patients from severe seizures that don’t respond to standard treatments.
The study, backed by an initial $9.3 million grant from the National Institutes of Health, aims to address a critical gap in current medical protocols for status epilepticus – a dangerous condition where seizures either persist beyond five minutes or occur in rapid succession without recovery.
The trial, known as KESETT (Ketamine add-on therapy for the Established Status Epilepticus Treatment Trial), comes at a crucial time when current treatments prove effective in less than half of adult patients. According to current data, standard anticonvulsant medications successfully stop these severe seizures in only 47% of adults and 52% of children.
“We wish to determine whether adding ketamine to existing treatment would terminate status epilepticus in more patients than the current treatment,” said Dr. Jaideep Kapur, co-director of UVA’s Brain Institute and an epileptologist at UVA Health and the School of Medicine. “Our hope is that this trial can improve treatment guidelines for patients suffering from these dangerous seizures.”
The stakes are particularly high for patients experiencing status epilepticus. Without effective intervention, these prolonged seizures can lead to permanent brain damage or prove fatal. Current protocol relies on a class of drugs called benzodiazepines, but many patients show resistance to these treatments, leaving medical professionals with limited options.
This new research builds upon UVA’s previous groundbreaking work in the field. Their earlier Established Status Epilepticus Treatment Trial (ESETT) provided the first definitive comparison of three commonly used medications – levetiracetam, fosphenytoin, and valproate. That study revealed these drugs were roughly equal in effectiveness, but their success rate left significant room for improvement.
The selection of ketamine for this trial isn’t arbitrary. While the drug has recently gained public attention for various uses, it has a long-established safety record in emergency medicine as a sedative. Its known anticonvulsant properties make it a promising candidate for treating resistant seizures.
The KESETT trial will evaluate two different dosage levels of ketamine – 1 mg and 3 mg – as add-on therapy to existing treatments. The study design is particularly noteworthy for its inclusion of pediatric patients, with researchers expecting children between ages 1-17 to comprise approximately one-third of the trial participants.
Dr. Kapur emphasized the widespread impact this research could have: “Each year, as many as 160,000 Americans suffer from status epilepticus, and this trial promises to bring new and improved treatment for them.”
The scope of the trial is ambitious, with plans to conduct research at approximately 60 sites over several years. This multi-center approach should provide robust data about ketamine’s effectiveness across diverse patient populations.
Funded through the NIH’s National Institute of Neurological Disorders and Stroke (grant No. UG3NS131532), the trial represents a collaborative effort between UVA’s Brain Institute – an interdisciplinary program dedicated to solving complex neuroscience challenges – and other leading medical institutions across the country.
For the thousands of patients who don’t respond to current seizure treatments, this research offers new hope. If successful, the addition of ketamine to standard protocols could represent a significant advance in emergency epilepsy care, potentially saving lives and preventing long-term neurological damage in both adults and children.
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