At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 26 enrolled

Drug / intervention

Lorazepamdrug

Likely dose

Lorazepam 4 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02239380

NCT02239380Phase 3Completed

Compare CT.gov

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

Pfizer·interventional·Posted Sep 12, 2014·Updated Feb 18, 2019

In Brief

A Phase 3 clinical trial evaluating Lorazepam for Status Epilepticus. Completed, enrolled 26 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsStatus Epilepticus

CountriesJapan

Collaborators--

Timeline

Phase 3CompletedFinished

201520162017201820192020202120222023202420252026

First PostedSep 2014

Enrollment StartNov 2014

Primary CompletionAug 2016

TodayJul 2026

First PostedSep 12, 2014

Enrollment StartNov 1, 2014

Primary CompletionAug 1, 2016

TodayJul 2, 2026

Enrollment to primary: 1.8 yearsPosted 11.8 years ago

Interventions

Lorazepamdrug

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.