Status:
COMPLETED
Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
Lead Sponsor:
Pfizer
Conditions:
Status Epilepticus
Eligibility:
All Genders
3+ years
Phase:
PHASE3
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
- 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
- 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)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02239380
Start Date
November 1 2014
End Date
August 1 2016
Last Update
February 18 2019
Active Locations (20)
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1
Aichi Children's Health and Medical Center
Obu-shi, Aichi-ken, Japan, 474-8710
2
National Hospital Organization Fukuoka-Higashi Medical Center
Koga, Fukuoka, Japan, 811-3195
3
Hokkaido Medical Center for Child Health and Rehabilitation
Sapporo, Hokkaido, Japan, 006-0041
4
Nakamura Memorial Hospital
Sapporo, Hokkaido, Japan, 060-8570