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.

Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan

Status Epilepticus

Lorazepam

A Multi-center, Open-label, Non-controlled Study To Evaluate The Efficacy And Safety Of Lorazepam Intravenously Administered In Subjects With Status Epilepticus Or Repetitive Status Epilepticus

Participants with clinical benefit were defined as participants whose initial seizure
stopped within 10 minutes after initial dose (Dose 1) and who continued seizure-free for
at least 30 minutes after the completion of initial dose (Dose 1).

Percentage of participants whose initial seizure stopped within 10 minutes after the
administration of study drug (either Dose 1 or 2 [in 10 to 30 minutes from the initial
dose]) and who continued seizure-free for at least 30 minutes were analyzed and reported
in this outcome measure.

Percentage of participants whose seizures stopped within 10 minutes after the
administration of initial dose (Dose 1) of study drug and after any study drug dose
(either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to
be seizure-free for at least 12 hours post-dose were analyzed and reported in this
outcome measure.

Percentage of participants whose seizures stopped within 10 minutes after the
administration of initial dose (Dose 1) of study drug and after any study drug dose
(either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to
be seizure-free for at least 24 hours post-dose were analyzed and reported in this
outcome measure.

Time to resolution (in minutes) was defined as the duration between the administration of
study drug until the seizure resolved without receiving the prohibited medications.

Time to relapse (in minutes) was defined as duration from the time of study drug
administration to the time of relapse, as determined by investigator. Participants whose
seizure stops within 10 minutes without receiving the prohibited medications were
analyzed in this outcome measure.

An AE was any untoward medical occurrence in a participant who received study drug
without regard to possibility of causal relationship. An SAE was an AE resulting in any
of the following outcomes or deemed significant for any other reason: death; initial or
prolonged inpatient hospitalization; life threatening experience (immediate risk of
dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent were events between first dose of study drug to the end of study (Day
12), that were absent before treatment or that worsened relative to pre-treatment state.
AEs include both serious and non-serious adverse events.

Aichi Children's Health and Medical Center

National Hospital Organization Fukuoka-Higashi Medical Center

Hokkaido Medical Center for Child Health and Rehabilitation

Nakamura Memorial Hospital

Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status