Phase 3
Completed N=26
Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
Source: ClinicalTrials.gov NCT02239380 ↗Enrolled (actual)
26
Serious AEs
3.9%
Results posted
Feb 2019
Primary outcomePrimary: Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug — 48.0 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug |
48.0 | — |
| SECONDARY Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug |
64.0 | — |
| SECONDARY Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug |
32.0; 44.0 | — |
| SECONDARY Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug |
24.0; 32.0 | — |
| SECONDARY Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug |
1.0; 1.0 | — |
| SECONDARY Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug |
62.0; 103.0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
12; 1 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02239380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.