Abstract
BackgroundStatus epilepticus (SE) is an emergency condition for which rapid and secured cessation is important. Phenytoin and fosphenytoin, the prodrug of phenytoin with less severe adverse effects, have been recommended as second-line treatments. However, fosphenytoin causes severe adverse events, such as hypotension and arrhythmia. Levetiracetam reportedly has similar efficacy and higher safety for SE; however, evidence to support its use for adult SE is lacking. In the present study, a non-inferiority designed multicenter randomized controlled trial (RCT) is being conducted to compare levetiracetam with fosphenytoin after diazepam as a second-line treatment for SE.MethodsThis multicenter, prospective, and open-label RCT is conducted in emergency departments. Between December 23, 2019, and March 31, 2023, 176 patients with convulsive SE transported to an emergency room will be randomized into a fosphenytoin group and levetiracetam group at a ratio of 1:1. The definition of SE is “continuous seizures longer than 5 min or discrete seizures longer than 2 min with intervening consciousness disturbance.” In both groups, diazepam is initially administered at 1–20 mg, followed by intravenous fosphenytoin at 22.5 mg/kg or intravenous levetiracetam at 1000–3000 mg. The primary outcome is the seizure cessation rate within 30 min. Seizure recurrence within 24 h, severe adverse events, and intubation rate within 24 h are secondary outcomes.DiscussionThe present study was approved and conducted as an initiative study of the Japanese Association for Acute Medicine. If non-inferiority is identified, the society will pursue an application for the national health insurance coverage of levetiracetam for SE via a public knowledge-based application.Trial registrationJapan Registry of Clinical Trials jRCTs031190160. Registered on December 13, 2019
Highlights
Background and rationale {6a} Status epilepticus (SE) is an emergency condition characterized by long-term convulsions
Objectives {7} The primary aim of the present study is to examine the non-inferiority of the efficacy of levetiracetam to that of fosphenytoin as a second-line treatment after diazepam for SE, which is defined as “continuous seizures longer than 5 min or discrete seizures longer than 2 min with intervening consciousness disturbance.”
We simultaneously examine and compare the safety of levetiracetam with that of fosphenytoin as a secondary objective
Summary
Background and rationale {6a} Status epilepticus (SE) is an emergency condition characterized by long-term convulsions. Along with resuscitation to stabilize respiration and circulation and prevent brain damage, including mechanical ventilation, rapid and secured seizure cessation by antiepileptic drugs (AEDs) is important [2]. Diazepam is available and often used as a first-line treatment in Japan Since these benzodiazepines only act for short periods, other long-acting AEDs are needed as second-line treatments to stop SE and prevent recurrence [5]. Status epilepticus (SE) is an emergency condition for which rapid and secured cessation is important. The prodrug of phenytoin with less severe adverse effects, have been recommended as second-line treatments. A non-inferiority designed multicenter randomized controlled trial (RCT) is being conducted to compare levetiracetam with fosphenytoin after diazepam as a second-line treatment for SE
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