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Ibaraki ER Network Epilepsy Control Trial with LevetIracetam vs. FosphEnytoine

LevetIracetam vs. Fosphenytoine for status epilepticus: multi-center randomised non-blinded control trial - IENE ECT with LIFE

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031190160
Enrollment
176
Registered
2019-12-16
Start date
2019-12-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

status epilepticus status epilepticus

Interventions

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 A
levetiracetam

Sponsors

Inoue Yoshiaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: status 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

Exclusion criteria

Exclusion criteria: under 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

Design outcomes

Primary

MeasureTime frame
seizure stop within 30 min from start of study drugs administration

Secondary

MeasureTime frame
seizure reccurence within 24 h severe adverse events intubation rate

Contacts

Public ContactKensuke Nakamura

Hitachi General Hospital

knakamura-tky@umin.ac.jp+81-294-23-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026