Clinical trial NCT02239380: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Status Epilepticus
Keywords: Lorazepam
Status Epilepticus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 26
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug
timeFrame: 30 minutes post Dose 1
Secondary outcomes:
measure: Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug
timeFrame: 30 minutes post Dose 1 or 2
measure: Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug
timeFrame: 12 hour post Dose 1; 12 hour post Dose 1 or 2
measure: Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug
timeFrame: 24 hour post Dose 1; 24 hour post Dose 1 or 2
measure: Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug
timeFrame: 10 minutes post Dose 1; 10 minutes post Dose 1 or 2
measure: Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug
timeFrame: 24 hour post Dose 1; 24 hour post Dose 1 or 2
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 7 days after last dose of study drug administration (up to 12 days)
Other outcomes:
Locations:
city: Obu-shi
country: Japan
facility: Aichi Children's Health and Medical Center
state: Aichi
city: Koga
country: Japan
facility: National Hospital Organization Fukuoka-Higashi Medical Center
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido Medical Center for Child Health and Rehabilitation
state: Hokkaido
city: Sapporo
country: Japan
facility: Nakamura Memorial Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Medical Center
state: Hokkaido
city: Kobe
country: Japan
facility: Hyogo Prefectural Kobe Children's Hospital
state: Hyogo
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Ohmura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
state: Nagasaki
city: Niigata-shi
country: Japan
facility: National Nishi-Niigata Central Hospital / Pediatrics
state: Niigata
city: Okayama-shi
country: Japan
facility: Okayama University Hospital / Child Neurology
state: Okayama
city: Izumi
country: Japan
facility: Osaka Medical Center and Research Institute for Maternal and Child Health
state: Osaka
city: Miyakojima-ku
country: Japan
facility: Osaka City General Hospital Pediatric Neurology
state: Osaka
city: Shizuoka-city
country: Japan
facility: NHO Shizuoka Institute of Epilepsy and Neurological Disorders
state: Shizuoka
city: Kodaira
country: Japan
facility: National Center of Neurology and Psychiatry
state: Tokyo
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Fukuoka
country: Japan
facility: Fukuoka Children's Hospital
city: Fukuoka
country: Japan
facility: Fukuoka Sanno Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Gifu
country: Japan
facility: Gifu Prefectural General Medical Center
city: Saitama
country: Japan
facility: Saitama Children's Medical Center
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: