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

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NCT02239380

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
Aichi Children`s Health and Medical Center
Obu-shi, Aichi, 474-8710 Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Status Epilepticus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3+ months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT02239380
Pfizer
Completed
Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan

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NCT02239380
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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
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.
Not Provided
Interventional
Phase 3
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Status Epilepticus
Drug: 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.
Experimental: Lorazepam
Lorazepam intravenous formulation
Intervention: Drug: Lorazepam
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
August 2016
August 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
3 Months and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT02239380
B3541002
2017-000125-13 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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