NIPH Clinical Trials Search

JRCT ID: jRCTs031190160

Registered date:16/12/2019

Ibaraki ER Network Epilepsy Control Trial with LevetIracetam vs. FosphEnytoine

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedstatus epilepticus
Date of first enrollment25/12/2019
Target sample size176
Countries of recruitment
Study typeInterventional
Intervention(s)At first, diazepam 1 - 20 mg is given in both groups. Hosphenytoin group After diazepam, hosphenytoin 22.5mg/kg+normal saline 100ml is given DIV by under 3mg/kg/min or 150mg/min Levetiracetam group After diazepam, levetiracetam 1000-3000mg is given DIV by 2-5mg/kg/min


Primary Outcomeseizure stop within 30 min from start of study drugs administration
Secondary Outcomeseizure reccurence within 24 h severe adverse events intubation rate

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteriastatus epilepticus with convulsion, who were transfered by ambulance The difinition of status epilepticus is as follows; over 5 minutes of continuous seizures, or over 2 minutes discrete seizures between which there is incomplete recovery of consciousness over JCS II-30 exclude non-convulsive seizure
Exclude criteriaunder 20 years old patients who entried this study in the past patients in whom informed consent can not be obtained from proxies (If proxies can not be found, the study is performed and the consent is obtained after action. already intubated patients before treatment allergy to fosphenytoin or levetiracetam pregnancy pseudo-seizure medical doctor considered inapropriate

Related Information


Public contact
Name Kensuke Nakamura
Address 2-1-1 Jonancho Hitachi Ibaraki Ibaraki Japan 317-0077
Telephone +81-294-23-1111
Affiliation Hitachi General Hospital
Scientific contact
Name Yoshiaki Inoue
Address 2-1-1 Amakubo Tsukuba Ibaraki Ibaraki Japan 305-8575
Telephone +81-29-853-3210
Affiliation University of Tsukuba Hospital