Conditions: Status Epilepticus
Keywords: Lorazepam Status Epilepticus
Allocation:  | Intervention model: PARALLEL
Enrollment: 26
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy, safety and pharmacokinetics of Lorazepam on Japanese patients with Status Epilepticus or Repetitive Status Eplilepticus.

Detailed description:

Arms:
arm 1: Lorazepam intravenous formulation

Interventions: intervention 1: Lorazepam
Intervention descriptions: intervention 1: intravenous administration. Dosage for adult subjects (16 years aged and over): 4 mg Dosage for pediatric subjects (3 months to \< 16 years): 0.05 mg/kg (but not exceeding 4 mg) Frequency: Intravenous administration of lorazepam. Subjects whose seizure does not stop or recurs within 10 minutes after the initial dose may receive the same amount of lorazepam injection no earlier than 10 minutes following the initial dose.

Also, subjects whose seizure stops within 10 minutes after the initial dose, but recurs thereafter (within 12 hours) may receive the same amount of lorazepam injection; a total of 2 doses will be permitted in this study.

Protocol document: