A Phase III study to evaluate the efficacy and safety of NRL-1 intranasally administered in Japanese pediatric patients with status epilepticus

JRCT ID: jRCT2031220265

Registered date:11/08/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Japanese pediatric patients with status epilepticus or with seizures that may progress to status epi
• Date of first enrollment: 15/12/2022
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Single intranasal administration of NRL-1 (diazepam, spray) at 3 doses(5, 10, 20 mg)

Outcome(s)

Primary Outcome

Part 1
- 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.

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: < 18age old
• Gender: Both
• Include criteria: Japanese pediatric patients with or at risk for status epilepticus
• Exclude 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

Related Information

• Primary Sponsor: Nakagawa Eiji