Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients

Completed

• Conditions: Insomnia
• Interventions: Drug: Eszopiclone

• Registration Number: NCT02455271
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-01
• Primary Completion: 2015-03-30
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-22
• Study First Posted: 2015-05-27
• Study Completion: 2015-12-22
• Status Verified: 2017-01
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

1. Participants who have completed LUN01S and need to continue eszopiclone

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with insomnia	Eszopiclone	Participants with insomnia who will receive eszopiclone per approved label.

Primary Outcome Measures

Name	Time	Method
Assessment of overall improvement	At month 6	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

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	Up to 6 months