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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455271
• Other study ID #: LUN02T
• Status: Completed
• Start date: October 1, 2012
• Est. completion date: December 22, 2015

Study information

• Verified date: January 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: December 22, 2015
• Est. primary completion date: March 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Eszopiclone
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Japanese Journal of Sleep Medicine 11: 81-94, 2017.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of participants with adverse events (AEs)		Up to 6 months