UMIN-CTR Clinical Trial

Public title

Evaluation of withdrawal symptoms and prognosis of eszopiclone - treated chronic insomnia patients

Acronym

Evaluation of withdrawal symptoms and prognosis of eszopiclone - treated chronic insomnia patients(LUN 1001)

Scientific Title

Evaluation of withdrawal symptoms and prognosis of eszopiclone - treated chronic insomnia patients

Scientific Title:Acronym

Evaluation of withdrawal symptoms and prognosis of eszopiclone - treated chronic insomnia patients(LUN 1001)

Region

Japan

Condition

chronic insomnia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yuichi Inoue

Organization

Yoyogi Sleep Disorder Center

Division name

NA

Zip code

Address

1-24-10,Yoyogi,shibuya-ku,Tokyo151-0053,

TEL

03-3374-9112

Email

inoue@somnology.com

Name of contact person

1st name
Middle name
Last name	Kiyomi Ishii

Organization

APO PLUS STATION Co.,LTD

Division name

Clinical Study Dept.CRO Business Div

Zip code

Address

2-14-1,Nihonbashi,Chuo-ku,Tokyo 103-0027 Japan

TEL

03-6386-8800

Homepage URL

Email

lun1001@apoplus.co.jp

Institute

Yoyogi Sleep Disorder Center

Institute

Department

Personal name

Organization

Eisai Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

10

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

08

Month

29

Day

Date of IRB

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

Other related information

Registered date

2016

Year

10

Month

18

Day

Last modified on

2018

Year

08

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028151