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

NCT ID: NCT02239380

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-08-31

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.

Conditions

Status Epilepticus

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lorazepam

Lorazepam intravenous formulation

Group Type: EXPERIMENTAL

Lorazepam

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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

Countries

Japan

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3541002&StudyName=Lorazepam%20for%20the%20Treatment%20of%20Status%20Epilepticus%20or%20Repetitive%20Status%20Epilepticus%20in%20Japan

To obtain contact information for a study center near you, click here.

Other Identifiers

2017-000125-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B3541002

Identifier Type: -

Identifier Source: org_study_id