Back to resultsLorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
Primary Purpose
Status Epilepticus
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Lorazepam
Sponsored by
About this trial
This is an interventional treatment trial for Status Epilepticus focused on measuring Lorazepam, Status Epilepticus
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)
Sites / Locations
- Aichi Children's Health and Medical Center
- National Hospital Organization Fukuoka-Higashi Medical Center
- Hokkaido Medical Center for Child Health and Rehabilitation
- Nakamura Memorial Hospital
- National Hospital Organization Hokkaido Medical Center
- Hyogo Prefectural Kobe Children's Hospital
- Tohoku University Hospital
- National Hospital Organization Nagasaki Medical Center
- National Nishi-Niigata Central Hospital / Pediatrics
- Okayama University Hospital / Child Neurology
- Osaka Medical Center and Research Institute for Maternal and Child Health
- Osaka City General Hospital Pediatric Neurology
- NHO Shizuoka Institute of Epilepsy and Neurological Disorders
- National Center of Neurology and Psychiatry
- Yamanashi Prefectural Central Hospital
- Fukuoka Children's Hospital
- Fukuoka Sanno Hospital
- Fukuoka University Hospital
- Gifu Prefectural General Medical Center
- Saitama Children's Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lorazepam
Arm Description
Lorazepam intravenous formulation
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug
Percentage of participants whose initial seizure stopped within 10 minutes after the administration of study drug (either Dose 1 or 2 [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 30 minutes were analyzed and reported in this outcome measure.
Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug
Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 12 hours post-dose were analyzed and reported in this outcome measure.
Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug
Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 24 hours post-dose were analyzed and reported in this outcome measure.
Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug
Time to resolution (in minutes) was defined as the duration between the administration of study drug until the seizure resolved without receiving the prohibited medications.
Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug
Time to relapse (in minutes) was defined as duration from the time of study drug administration to the time of relapse, as determined by investigator. Participants whose seizure stops within 10 minutes without receiving the prohibited medications were analyzed in this outcome measure.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (Day 12), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02239380
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Epilepticus
Keywords
Lorazepam, Status Epilepticus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lorazepam
Arm Type
Experimental
Arm Description
Lorazepam intravenous formulation
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug
Description
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).
Time Frame
30 minutes post Dose 1
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug
Description
Percentage of participants whose initial seizure stopped within 10 minutes after the administration of study drug (either Dose 1 or 2 [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 30 minutes were analyzed and reported in this outcome measure.
Time Frame
30 minutes post Dose 1 or 2
Title
Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug
Description
Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 12 hours post-dose were analyzed and reported in this outcome measure.
Time Frame
12 hour post Dose 1; 12 hour post Dose 1 or 2
Title
Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug
Description
Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 24 hours post-dose were analyzed and reported in this outcome measure.
Time Frame
24 hour post Dose 1; 24 hour post Dose 1 or 2
Title
Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug
Description
Time to resolution (in minutes) was defined as the duration between the administration of study drug until the seizure resolved without receiving the prohibited medications.
Time Frame
10 minutes post Dose 1; 10 minutes post Dose 1 or 2
Title
Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug
Description
Time to relapse (in minutes) was defined as duration from the time of study drug administration to the time of relapse, as determined by investigator. Participants whose seizure stops within 10 minutes without receiving the prohibited medications were analyzed in this outcome measure.
Time Frame
24 hour post Dose 1; 24 hour post Dose 1 or 2
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (Day 12), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events.
Time Frame
Baseline up to 7 days after last dose of study drug administration (up to 12 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Aichi Children's Health and Medical Center
City
Obu-shi
State/Province
Aichi
ZIP/Postal Code
474-8710
Country
Japan
Facility Name
National Hospital Organization Fukuoka-Higashi Medical Center
City
Koga
State/Province
Fukuoka
ZIP/Postal Code
811-3195
Country
Japan
Facility Name
Hokkaido Medical Center for Child Health and Rehabilitation
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
006-0041
Country
Japan
Facility Name
Nakamura Memorial Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8570
Country
Japan
Facility Name
National Hospital Organization Hokkaido Medical Center
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
063-0005
Country
Japan
Facility Name
Hyogo Prefectural Kobe Children's Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
National Hospital Organization Nagasaki Medical Center
City
Ohmura
State/Province
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
Facility Name
National Nishi-Niigata Central Hospital / Pediatrics
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
950-2085
Country
Japan
Facility Name
Okayama University Hospital / Child Neurology
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka Medical Center and Research Institute for Maternal and Child Health
City
Izumi
State/Province
Osaka
ZIP/Postal Code
594-1101
Country
Japan
Facility Name
Osaka City General Hospital Pediatric Neurology
City
Miyakojima-ku
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
City
Shizuoka-city
State/Province
Shizuoka
ZIP/Postal Code
420-8688
Country
Japan
Facility Name
National Center of Neurology and Psychiatry
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Fukuoka Children's Hospital
City
Fukuoka
ZIP/Postal Code
813-0017
Country
Japan
Facility Name
Fukuoka Sanno Hospital
City
Fukuoka
ZIP/Postal Code
814-0001
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Gifu Prefectural General Medical Center
City
Gifu
ZIP/Postal Code
500-8717
Country
Japan
Facility Name
Saitama Children's Medical Center
City
Saitama
ZIP/Postal Code
339-8551
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3541002&StudyName=Lorazepam%20for%20the%20Treatment%20of%20Status%20Epilepticus%20or%20Repetitive%20Status%20Epilepticus%20in%20Japan
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
We'll reach out to this number within 24 hrs