臨床研究等提出・公開システム

Scientific Title	Phase 3 Study to Evaluate the Efficacy and Safety of Orally Administered BF2.649 in Japanese Patients with Narcolepsy, Consisting of a Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study (Part 1) and Subsequent Open-label Extension Study (Part 2)
Public Title	Phase 3 Study to Evaluate the Efficacy and Safety of Orally Administered BF2.649 in Japanese Patients with Narcolepsy, Consisting of a Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study (Part 1) and Subsequent Open-label Extension Study (Part 2)

Contact for Scientific Queries	Name	Uchimura Naohisa
	Affiliation	Kurume University Hospital
	Address	1-1-1, Shibaura, Minato-ku, Tokyo
	Telephone	+81-80-8700-5366
	E-mail	PM_PitolisantP1_PM@cmic.co.jp
Contact for Public Queries	Name	Ono Chihiro
	Affiliation	CMIC Co., Ltd.
	Address	1-1-1, Shibaura, Minato-ku, Tokyo
	Telephone	+81-80-8700-5366
	E-mail	ClinicalTrialInformation@cmic.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Nov. 01, 2022
Actual date of first enrollment		Nov. 09, 2022
Target sample size		123
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Japanese males and females aged 15 or older and less than 65 - Individuals who have been diagnosed with narcolepsy (type 1 or type 2) - ESS score is at least 14
	Exclusion Criteria	Apnea hypopnea index (AHI) is 15 or above, or Periodic limb movement arousal index (PLMAI) is 10 or above.
	Age Minimum	15age old over
	Age Maximum	65age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Narcolepsy
Intervention(s)		BF2.649 tablets(10 mg or 20 mg or 40 mg) or placebo tablets
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		To evaluate the effect of oral administration of BF2.649 for 8 weeks on the improvement of excessive daytime sleepiness by comparing Epworth Sleepiness Scale (ESS) with placebo in patients with narcolepsy.
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	Kobori Central Clinical Research Ethics Committee
Address	5-11-8, Nishi-nippori, Arakawa-ku, Tokyo
Telephone	+81-3-6779-8166
E-Mail
Approval Status	Approval
Date of approval	Sept. 22, 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