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

NCT02239380 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-02-18

Study results available
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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.

Conditions

  • Status Epilepticus

Interventions

DRUG

Lorazepam

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02239380 on ClinicalTrials.gov