---
title: Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
nct_id: NCT02239380
overall_status: COMPLETED
phase: PHASE3
sponsor: Pfizer
study_type: INTERVENTIONAL
primary_condition: Status Epilepticus
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02239380.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02239380"
ct_last_update_post_date: 2019-02-18
last_seen_at: "2026-05-12T06:12:32.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan

**Official Title:** 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

**NCT ID:** [NCT02239380](https://clinicaltrials.gov/study/NCT02239380)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 26
- **Lead Sponsor:** Pfizer
- **Conditions:** Status Epilepticus
- **Start Date:** 2014-11
- **Completion Date:** 2016-08
- **CT.gov Last Update:** 2019-02-18

## 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.

## Eligibility

- **Minimum age:** 3 Months
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Subjects with status epilepticus or repetitive status epilepticus / cluster seizure who have seizures that can be evaluated by investigator's visual observations based on motor symptoms or who have seizures that can be evaluated by EEG.
* Subjects with status epilepticus accompanied by generalized seizure, partial seizure or secondarily generalized seizure lasting 5 minutes or longer
* Subjects with repetitive status epilepticus / cluster seizure accompanied by not less than 3 consecutive episodes of generalized seizure, partial seizure or secondarily generalized seizure in 1 hour.
* Subjects not younger than 3 months (either gender is eligible for the study)

Exclusion Criteria:

* Subjects with known or suspected recurrent seizures due to illegal drug or alcohol withdrawal
* Subjects with known history of hypersensitivity to lorazepam or benzodiazepine
* Subjects with a known history of benzodiazepine abuse.
* Subjects currently receiving lorazepam
* Subjects with angle-closure glaucoma
* Subjects with myasthenia gravis
* Subjects with either of aspartate transaminase, alanine transaminase, total bilirubin, blood urea nitrogen, or creatinine at screening visit exceeding 2x the upper limit of normal of the institutional reference value (if the data is available)
* Subjects with white blood cell count less than 3000/mm3 or neutrophil count less than 1500/mm3 at screening visit (if the data is available)
```

## Arms

- **Lorazepam** (EXPERIMENTAL) — Lorazepam intravenous formulation

## Interventions

- **Lorazepam** (DRUG) — 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.

## Primary Outcomes

- **Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug** _(time frame: 30 minutes post Dose 1)_ — 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).

## Secondary Outcomes

- **Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug** _(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** _(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** _(time frame: 24 hour post Dose 1; 24 hour post Dose 1 or 2)_
- **Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug** _(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 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)** _(time frame: Baseline up to 7 days after last dose of study drug administration (up to 12 days))_

## Locations (20)

- Aichi Children's Health and Medical Center, Obu-shi, Aichi-ken, Japan
- 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
- Osaka Medical Center and Research Institute for Maternal and Child Health, Izumi, Osaka, Japan
- Osaka City General Hospital Pediatric Neurology, Miyakojima-ku, Osaka, Japan
- NHO Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka, Shizuoka, Japan
- National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan
- Yamanashi Prefectural Central Hospital, Kofu, Yamanashi, Japan
- Fukuoka Children's Hospital, Fukuoka, Japan
- Fukuoka Sanno Hospital, Fukuoka, Japan
- Fukuoka University Hospital, Fukuoka, Japan
- Gifu Prefectural General Medical Center, Gifu, Japan
- Saitama Children's Medical Center, Saitama, Japan

## Recent Field Changes (last 30 days)

- `locations.osaka city general hospital pediatric neurology|miyakojima-ku|osaka|japan` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `locations.nho shizuoka institute of epilepsy and neurological disorders|shizuoka|shizuoka|japan` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.aichi children's health and medical center|obu-shi|aichi-ken|japan` — added _(2026-05-12)_
- `locations.national hospital organization fukuoka-higashi medical center|koga|fukuoka|japan` — added _(2026-05-12)_
- `locations.hokkaido medical center for child health and rehabilitation|sapporo|hokkaido|japan` — added _(2026-05-12)_
- `locations.nakamura memorial hospital|sapporo|hokkaido|japan` — added _(2026-05-12)_
- `locations.national hospital organization hokkaido medical center|sapporo|hokkaido|japan` — added _(2026-05-12)_
- `locations.hyogo prefectural kobe children's hospital|kobe|hyōgo|japan` — added _(2026-05-12)_
- `locations.tohoku university hospital|sendai|miyagi|japan` — added _(2026-05-12)_
- `locations.national hospital organization nagasaki medical center|ohmura|nagasaki|japan` — added _(2026-05-12)_
- `locations.national nishi-niigata central hospital / pediatrics|niigata|niigata|japan` — added _(2026-05-12)_
- `locations.okayama university hospital / child neurology|okayama|okayama-ken|japan` — added _(2026-05-12)_
- `locations.osaka medical center and research institute for maternal and child health|izumi|osaka|japan` — added _(2026-05-12)_
- `locations.national center of neurology and psychiatry|kodaira|tokyo|japan` — added _(2026-05-12)_
- `locations.yamanashi prefectural central hospital|kofu|yamanashi|japan` — added _(2026-05-12)_
- `locations.fukuoka children's hospital|fukuoka||japan` — added _(2026-05-12)_
- `locations.fukuoka sanno hospital|fukuoka||japan` — added _(2026-05-12)_
- `locations.fukuoka university hospital|fukuoka||japan` — added _(2026-05-12)_
- `locations.gifu prefectural general medical center|gifu||japan` — added _(2026-05-12)_
- `locations.saitama children's medical center|saitama||japan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02239380.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02239380*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*