Ketamine + Levetiracetam for Status Epilepticus

(KESETT Trial)

This trial aims to determine if adding ketamine (an anesthetic and pain reliever) to levetiracetam better controls status epilepticus (a severe and ongoing type of seizure) than levetiracetam alone. Participants will join one of three groups: one receiving levetiracetam with a high dose of ketamine, another with a low dose of ketamine, and a third group receiving only levetiracetam. Suitable candidates for this trial have experienced a seizure lasting more than five minutes, have already received benzodiazepines (a type of sedative), and continue to have seizures in the emergency room. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have been treated with certain anticonvulsants or sedatives for this seizure episode.

Research has shown that ketamine is generally safe and effective for treating status epilepticus, a severe type of seizure. In recent studies, ketamine stopped seizures in 23 out of 24 people, demonstrating its effectiveness for most participants without causing major issues. Ketamine has also been used safely in various treatments for many years.

Most treatments for status epilepticus, like benzodiazepines and anti-seizure medications, aim to stabilize electrical activity in the brain but can take time to work. Ketamine is unique because it acts on NMDA receptors, which are involved in a different pathway from traditional treatments. This potentially allows it to work even when other medications fail. Researchers are excited about combining ketamine with levetiracetam because the two drugs may have a synergistic effect, potentially offering faster and more effective seizure control. Additionally, the study is exploring both high and low doses, which might provide flexibility in treatment based on individual needs.

Research shows that adding ketamine to levetiracetam may help control seizures in people with status epilepticus, a severe type of seizure. Studies have found that ketamine can effectively stop ongoing seizures when other medicines, like midazolam, don't work. In this trial, participants will receive either levetiracetam alone or in combination with different doses of ketamine. Some evidence suggests that using ketamine with levetiracetam could be more effective than using levetiracetam alone. Specifically, one study showed that this combination improved seizure control to 62%. This suggests that using ketamine with levetiracetam might be a promising way to better manage seizures in status epilepticus.¹²⁴⁶⁷