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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Status Epilepticus

Treatments: Drug: Lorazepam

Study type: Interventional

Funder types: Industry

Identifiers

NCT02239380

B3541002

2017-000125-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 3+ months old

Volunteers: No Healthy Volunteers

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)

Trial design

26 participants in 1 patient group

Lorazepam

Experimental group

Description:

Lorazepam intravenous formulation

Treatment:

Drug: Lorazepam