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

NCT02239380

Last updated date
Study Location
Aichi Children's Health and Medical Center
Obu-shi, Aichi, 474-8710, Japan
Contact
1-800-718-1021

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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)

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Advanced Information
Descriptive Information
Brief Title  ICMJE Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Status Epilepticus
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: Lorazepam
Lorazepam intravenous formulation
Intervention: Drug: Lorazepam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2016)
26
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2014)
25
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 3 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02239380
Other Study ID Numbers  ICMJE B3541002
2017-000125-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP