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

A Phase III, multicenter, open-label study to evaluate the efficacy and safety of NRL-1 intranasally administered in Japanese pediatric patients with or at risk for status epilepticus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220265

Enrollment

Registered

2022-08-11

Start date

2022-12-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Japanese pediatric patients with status epilepticus or with seizures that may progress to status epi

Interventions

Single intranasal administration of NRL-1 (diazepam, spray) at 3 doses(5, 10, 20 mg)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Japanese pediatric patients with or at risk for status epilepticus

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Contacts

Public ContactJunichi Onuma

Aculys Pharma, Inc.

jonuma@aculys.com+81-3-4446-6420

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026