Treatment of Recurrent Electrographic Nonconvulsive Seizures (TRENdS) study

Nonconvulsive seizures (NCS) and nonconvulsive status epilepticus (NCSE) are electrographic seizures (ESz) that are not associated with overt clinical seizure activity. NCS are distinct ESz, whereas NCSE has ongoing, continuous electrographic seizure activity. Both are common in critically ill patients admitted to hospital intensive care units (ICUs), and studies have shown that about 20% of ICU patients undergoing continuous electroencephalography (cEEG) monitoring will have NCS/NCSE. Although the treatment for convulsive SE is well established, there is no clear consensus for the treatment of NCS/NCSE. Antiepileptic drugs (AEDs), such as phenytoin (PHT) and fosphenytoin (fPHT), used in convulsive SE are also used to treat NCS/NCSE despite lack of data for their appropriateness for these conditions. Recent studies have shown that very aggressive treatment of NCSss/NCSE can lead to worse outcomes because the AEDs used can have significant adverse effects. Recently, several intravenous (IV) AEDs have become available for substitution therapy when their oral use is not possible. There are retrospective case reports and case series that suggest that these AEDs may be beneficial for treatment of NCS/NCSE. The Treatment of Recurrent Electrographic Nonconvulsive Seizures (TRENdS) Study will compare the efficacy and tolerability of fPHT and lacosamide in patients having NCS as noted by cEEG monitoring. The study is currently open to recruitment and has 13 sites in the United States. A total of 200 subjects will be randomized, 100 to each treatment arm.