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

PHASE3CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

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."

Trial Locations (20)

474-8710

Aichi Children's Health and Medical Center, Obu-shi

811-3195

National Hospital Organization Fukuoka-Higashi Medical Center, Koga

006-0041

Hokkaido Medical Center for Child Health and Rehabilitation, Sapporo

060-8570

Nakamura Memorial Hospital, Sapporo

063-0005

National Hospital Organization Hokkaido Medical Center, Sapporo

650-0047

Hyogo Prefectural Kobe Children's Hospital, Kobe

980-8574

Tohoku University Hospital, Sendai

856-8562

National Hospital Organization Nagasaki Medical Center, Ohmura

950-2085

National Nishi-Niigata Central Hospital / Pediatrics, Niigata

700-8558

Okayama University Hospital / Child Neurology, Okayama

594-1101

Osaka Medical Center and Research Institute for Maternal and Child Health, Izumi

534-0021

Osaka City General Hospital Pediatric Neurology, Miyakojima-ku

420-8688

NHO Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka

187-8551

National Center of Neurology and Psychiatry, Kodaira

400-8506

Yamanashi Prefectural Central Hospital, Kofu

813-0017

Fukuoka Children's Hospital, Fukuoka

814-0001

Fukuoka Sanno Hospital, Fukuoka

814-0180

Fukuoka University Hospital, Fukuoka

500-8717

Gifu Prefectural General Medical Center, Gifu

339-8551

Saitama Children's Medical Center, Saitama

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02239380 - Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan | Biotech Hunter | Biotech Hunter