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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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.
Aichi Children's Health and Medical Center
Obu-shi, Aichi-ken, Japan
Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug
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).
Time frame: 30 minutes post Dose 1
Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug
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.
Time frame: 30 minutes post Dose 1 or 2
Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug
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.
Time frame: 12 hour post Dose 1; 12 hour post Dose 1 or 2
Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug
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 frame: 24 hour post Dose 1; 24 hour post Dose 1 or 2
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National Hospital Organization Fukuoka-Higashi Medical Center
Koga, Fukuoka, Japan
Hokkaido Medical Center for Child Health and Rehabilitation
Sapporo, Hokkaido, Japan
Nakamura Memorial Hospital
Sapporo, Hokkaido, Japan
National Hospital Organization Hokkaido Medical Center
Sapporo, Hokkaido, Japan
Hyogo Prefectural Kobe Children's Hospital
Kobe, Hyōgo, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
National Hospital Organization Nagasaki Medical Center
Ohmura, Nagasaki, Japan
National Nishi-Niigata Central Hospital / Pediatrics
Niigata, Niigata, Japan
Okayama University Hospital / Child Neurology
Okayama, Okayama-ken, Japan
...and 10 more locations
Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug
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 frame: 10 minutes post Dose 1; 10 minutes post Dose 1 or 2
Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug
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.
Time frame: 24 hour post Dose 1; 24 hour post Dose 1 or 2
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: Baseline up to 7 days after last dose of study drug administration (up to 12 days)