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

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

Completed

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants who have completed LUN01S and need to continue eszopiclone

Treatment and study plan

Eszopiclone

Drug

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.

Other names: EZOP; Lunesta

Primary outcomes

Assessment of overall improvement

Time frame: At month 3

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
Assessment of overall improvement

Time frame: 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 outcomes

Number of participants with adverse events (AEs)

Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients (Study LUN02T)

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: May 27, 2015
Registry last updated: Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed