NCT02239380

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-09-12
• Last updated: 2019-02-18
• Results posted: 2019-02-18

Locations

20 sites across 1 country: Japan