臨床研究等提出・公開システム

Date of registration	July. 23, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222564

Scientific Title	Long-Term Study of CN-801 - Open-label study in patients with excessive daytime sleepiness associated with idiopathic hypersomnia -
Public Title	Long-Term Study of CN-801 in patients with idiopathic hypersomnia

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Alfresa Pharma Corporation
	Address	iyaku-chiken@alfresa-pharma.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Uncontrolled, open-label, multi-center study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Patients diagnosed with idiopathic hypersomnia based on the International Classification of Sleep Disorders, second edition (ICSD-2) and who have completed the preceding double-blind comparative study
	Exclusion Criteria	Patients with narcolepsy, restless legs syndrome, periodic limb movement disorder, or sleep apnea syndrome Patients working irregular shifts or night shifts Patients with chronic sleep deprivation or patients with extremely irregular bed times
	Minimum Age	16age old over
	Maximum Age	64age old under
	Gender	Both
Health Condition or Problem Studied		Idiopathic hypersomnia
Intervention(s)		investigational material(s) Generic name etc : CN-801 INN of investigational material : modafinil Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material : oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safty, Efficacy (Japanese version of the Epworth Sleepiness Scale)
Secondary Outcome

Primary Sponsor	Alfresa Pharma Corporation
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-142615
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Nov. 30, 2018	Detail	Changes
7	Nov. 30, 2018	Detail	Changes
6	Feb. 02, 2017	Detail	Changes
5	Feb. 02, 2017	Detail	Changes
4	Dec. 02, 2015	Detail	Changes
3	Dec. 02, 2015	Detail	Changes
2	July. 23, 2014	Detail	Changes
1	July. 23, 2014	Detail

List of change history