A Phase III study to evaluate the efficacy and safety of NRL-1 intranasally administered in Japanese pediatric patients with status epilepticus
Completed
- Conditions
- Japanese pediatric patients with status epilepticus or with seizures that may progress to status epi
- Registration Number
- jRCT2031220265
- Lead Sponsor
- Aculys Pharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Japanese pediatric patients with or at risk for status epilepticus
Exclusion Criteria
Patients who in the opinion of the Investigator or Subinvestigator, previously failed to respond to diazepam injected within 5 minutes after onset of seizures
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method Proportion of subjects with status epilepticus or with seizures that may progress to status epilepticus, who achieve seizure cessation after a single dose of intranasal NRL-1 without recurrence To evaluate the proportion of subjects with status epilepticus or with seizures that may progress to status epilepticus, who achieve seizure cessation after a single dose of intranasal NRL-1 without recurrence
- Secondary Outcome Measures
Name Time Method