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
2 other identifiers
interventional
26
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2014
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2014
CompletedFirst Posted
Study publicly available on registry
September 12, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
February 18, 2019
CompletedFebruary 18, 2019
October 1, 2018
1.8 years
September 10, 2014
December 18, 2017
October 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug
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).
30 minutes post Dose 1
Secondary Outcomes (6)
Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug
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
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
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
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
24 hour post Dose 1; 24 hour post Dose 1 or 2
- +1 more secondary outcomes
Study Arms (1)
Lorazepam
EXPERIMENTALLorazepam intravenous formulation
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (20)
Aichi Children's Health and Medical Center
Obu-shi, Aichi-ken, 474-8710, Japan
National Hospital Organization Fukuoka-Higashi Medical Center
Koga, Fukuoka, 811-3195, Japan
Hokkaido Medical Center for Child Health and Rehabilitation
Sapporo, Hokkaido, 006-0041, Japan
Nakamura Memorial Hospital
Sapporo, Hokkaido, 060-8570, Japan
National Hospital Organization Hokkaido Medical Center
Sapporo, Hokkaido, 063-0005, Japan
Hyogo Prefectural Kobe Children's Hospital
Kobe, Hyōgo, 650-0047, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
National Hospital Organization Nagasaki Medical Center
Ohmura, Nagasaki, 856-8562, Japan
National Nishi-Niigata Central Hospital / Pediatrics
Niigata, Niigata, 950-2085, Japan
Okayama University Hospital / Child Neurology
Okayama, Okayama-ken, 700-8558, Japan
Osaka Medical Center and Research Institute for Maternal and Child Health
Izumi, Osaka, 594-1101, Japan
Osaka City General Hospital Pediatric Neurology
Miyakojima-ku, Osaka, 534-0021, Japan
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka, 420-8688, Japan
National Center of Neurology and Psychiatry
Kodaira, Tokyo, 187-8551, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506, Japan
Fukuoka Children's Hospital
Fukuoka, 813-0017, Japan
Fukuoka Sanno Hospital
Fukuoka, 814-0001, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Gifu Prefectural General Medical Center
Gifu, 500-8717, Japan
Saitama Children's Medical Center
Saitama, 339-8551, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2014
First Posted
September 12, 2014
Study Start
November 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
February 18, 2019
Results First Posted
February 18, 2019
Record last verified: 2018-10