臨床研究等提出・公開システム

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

Contact for Scientific Queries	Name	Nakagawa Eiji
	Affiliation	National Center of Neurology and Psychiatry
	Address	the ARGYLE aoyama 6F, 2-14-4 KitaAoyama, Minato-ku, Tokyo
	Telephone	+81-3-4446-6420
	E-mail	jonuma@aculys.com
Contact for Public Queries	Name	Onuma Junichi
	Affiliation	Aculys Pharma, Inc.
	Address	the ARGYLE aoyama 6F, 2-14-4 KitaAoyama, Minato-ku, Tokyo
	Telephone	+81-3-4446-6420
	E-mail	jonuma@aculys.com

Recruitment status	Complete

Anticipated date of first enrollment		Aug. 31, 2022
Actual date of first enrollment		Dec. 15, 2022
Target sample size		15
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	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
	Age Minimum	6age old over
	Age Maximum	18age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Japanese pediatric patients with status epilepticus or with seizures that may progress to status epi
Intervention(s)		Single intranasal administration of NRL-1 (diazepam, spray) at 3 doses(5, 10, 20 mg)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		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.
Secondary Outcome(s)

Primary Sponsor	Aculys Pharma, Inc.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	IRB of Nishiniigata Chuo Hospital
Address	1-14-1, Masago, Nishi-ku, Niigata-city, Niigata, Niigata
Telephone	+81-25-265-3171
E-Mail
Approval Status	Approval
Date of approval	July. 13, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history