Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
NCT02239380
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- 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)
- 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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| 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 | 26 | |||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||