NCT02452684

Brief Summary

To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in insomnia patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,876

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2015

Completed
Last Updated

September 7, 2018

Status Verified

January 1, 2017

Enrollment Period

2.1 years

First QC Date

May 19, 2015

Last Update Submit

September 6, 2018

Conditions

Insomnia

Keywords

Insomnia

Outcome Measures

Primary Outcomes (1)

  • Assessment of overall improvement

    Participants will be interviewed regarding sleep improvement at 4 weeks after first dose or discontinuation relative to predose, and select the appropriate answer of: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible

    Up to 4 weeks

Secondary Outcomes (1)

  • Number of participants with adverse events (AEs)

    Up to 4 weeks

Study Arms (1)

Participants with insomnia

Participants with insomnia who will receive eszopiclone, per approved label.

Drug: Eszopiclone

Interventions

EszopicloneDRUG

The usual dosage of eszopiclone is 2 mg per dose for adults and 1 mg per dose for elderly participants, taken orally before bedtime. The dosage may be adjusted according to the participant's symptoms, but a single dose should not exceed 3 mg in adults and 2 mg in elderly participants.

Also known as: EZOP; Lunesta
Participants with insomnia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Insomnia participants who did not take eszopiclone before assessment

You may qualify if:

  • Insomnia participants who did not take eszopiclone before assessment
  • Participants who receive assessment by using sleep questionaries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

  • Japanese Journal of Sleep Medicine 10 : 425-441, 2016.

    RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesPyridines

Study Officials

  • Akira Endo

    Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 25, 2015

Study Start

October 1, 2012

Primary Completion

November 11, 2014

Study Completion

December 22, 2015

Last Updated

September 7, 2018

Record last verified: 2017-01

Locations

JP(2)