UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of withdrawal symptoms and prognosis of eszopiclone - treated chronic insomnia patients
Title of the study (Brief title)	Evaluation of withdrawal symptoms and prognosis of eszopiclone - treated chronic insomnia patients(LUN 1001)
Region	Japan

Condition
Condition	chronic insomnia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Withdrawal symptoms are evaluated in chronic insomnia patients with eszopiclone for 24 weeks by using withdrawal symptom evaluating questionnaires, furthermore, factors which influence withdrawal symptoms are examined in an exploring manner.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Mean/median of sleep withdrawal symptoms questionnaire
Key secondary outcomes	(1) sleeping drug withdrawal syndrome incidence (2) Means/medians of ISI, SF-8 and Bendep-SRQ SV (3) Factors which correlate with sleep withdrawal symptoms questionnaire (e.g. ISI, SF-8, Bendep-SRQ SV, Population dynamics, etc.) (4) Factors which correlate with ISI, SF-8 in the 24th week (e.g. ISI,SF-8 in the 4th week, Population dynamics, etc.) (5) Remission rate end of 2 weeks administration <Safety> Number and incidence of adverse events and the expression number of side effects, incidence

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	I give 2 mg of Eszopiclone once orally before going to bed.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Patients meeting ICSD-III criteria for chronic insomnia (2)Patients whose informed consent is obtained and patients capable of visits once a month (3)Patients aged 20 years - less than 65 years at obtaining informed consent (non-elderly patients)
Key exclusion criteria	(1)Patients taking hypnotics within two weeks before registration (2)Patient having or having anamnestic history of following diseases, risk of suicide, (mild)manic episode, post-traumatic stress disorder, alcohol dependency and abuse, drug(non-alcoholic) dependency and abuse, anorexia nervosa, bulimia nervosa, antisocial personality disorder (3)Patients with drug-induced insomnia (4)Patients with other sleep disorders (circadian rhythm disorder, restless legs syndrome, periodic limb movement disability, sleep apnea syndrome, etc.) (5)Patients with symptoms such as pain, fever, diarrhea, frequent urination, and coughs that remarkably disturbs sleep (6)Patients under unstable condition of underlying disease that causes insomnia for 4 weeks before obtaining informed consent (7)Patients with possibility of organic mental disorder (8)Patients who are engaged in driving a car or operating a risky machine (9)Patients of shift work workers and patients with jet lag (10)Patients with anamnestic history of hypersensitivity for eszopiclone or zopiclone (11)Patient with myasthenica gravis (12)Patients with acute narrow-angle glaucoma (13)Patients with highly impaired respiratory function by pulmonary heart, emphysema, bronchial asthma or acute phase of cerebrovascular disorders (14)Patients who are determined unsuitable by principal investigators
Target sample size	180

Research contact person
Name of lead principal investigator	Yuichi Inoue
Organization	Yoyogi Sleep Disorder Center
Division name	NA
Address	1-24-10,Yoyogi,shibuya-ku,Tokyo151-0053,
TEL	03-3374-9112
Email	inoue@somnology.com

Public contact
Name of contact person	Kiyomi Ishii
Organization	APO PLUS STATION Co.,LTD
Division name	Clinical Study Dept.CRO Business Div
Address	2-14-1,Nihonbashi,Chuo-ku,Tokyo 103-0027 Japan
TEL	03-6386-8800
Homepage URL
Email	lun1001@apoplus.co.jp

Sponsor
Institute	Yoyogi Sleep Disorder Center
Institute
Department

Funding Source
Organization	Eisai Co.,Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 29 Day
Anticipated trial start date	2016 Year 10 Month 20 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 18 Day
Last modified on	2018 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028151