Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients
1 other identifier
observational
438
1 country
2
Brief Summary
To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2015
CompletedFirst Submitted
Initial submission to the registry
May 19, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2015
CompletedSeptember 7, 2018
January 1, 2017
2.5 years
May 19, 2015
September 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Assessment of overall improvement
Participants will be interviewed regarding sleep improvement at 3 months after first dose or discontinuation, relative to predose, and select the appropriate answer of: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible
At month 3
Assessment of overall improvement
Participants will be interviewed regarding sleep improvement at 6 months after first dose or discontinuation, relative to predose, and select the appropriate answer: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible
At month 6
Secondary Outcomes (1)
Number of participants with adverse events (AEs)
Up to 6 months
Study Arms (1)
Participants with insomnia
Participants with insomnia who will receive eszopiclone per approved label.
Interventions
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.
Eligibility Criteria
Participants who have completed Study LUN01S and need to continue eszopiclone
You may qualify if:
- \. Participants who have completed LUN01S and need to continue eszopiclone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (2)
Unknown Facility
Osaka, Japan
Unknown Facility
Tokyo, Japan
Related Publications (1)
Japanese Journal of Sleep Medicine 11: 81-94, 2017.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Akira Endo
Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
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 27, 2015
Study Start
October 1, 2012
Primary Completion
March 30, 2015
Study Completion
December 22, 2015
Last Updated
September 7, 2018
Record last verified: 2017-01