Phase 3 Clinical Trial of AF-0901 in children with status epilepticus
Phase 3
- Conditions
- Status epilepticus
- Registration Number
- JPRN-jRCT2080223531
- Lead Sponsor
- Alfresa Pharma Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with a seizure episode lasting for 15 minutes or longer, or with multiple seizures lasting for 5 minutes or longer, who are confirmed to have a history of status epilepticus from medical records.
Patients whose seizures did not cease with intravenous diazepam, or those with a recent history of unsuccessful cessation of seizure with intravenous diazepam.
Exclusion Criteria
Patients with non-convulsive status epilepticus, acute narrow angle glaucoma or myasthenia gravis, those receiving combination therapy with an HIV protease inhibitor or HIV reverse transcriptase inhibitor, and those with a hypersensitivity to midazolam or benzodiazepine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy<br>Achievement of seizure cessation by intravenous bolus injection
- Secondary Outcome Measures
Name Time Method safety, pharmacokinetics