Overview

This trial has been completed.

Condition insomnia
Treatment eszopiclone
Sponsor Eisai Co., Ltd.
Start date October 2012
End date March 2015
Trial size 438 participants
Trial identifier NCT02455271, LUN02T

Summary

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Participants with insomnia who will receive eszopiclone per approved label.
eszopiclone EZOP; Lunesta
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.

Primary Outcomes

Measure
Assessment of overall improvement
time frame: At month 3
Assessment of overall improvement
time frame: At month 6

Secondary Outcomes

Measure
Number of participants with adverse events (AEs)
time frame: Up to 6 months

Eligibility Criteria

All participants of any age.

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

Additional Information

Official title Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients (Study LUN02T)
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Eisai Inc..