Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients (Study LUN02T)
| Registry | NCT02455271 |
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| Status | Completed |
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| Study type | Observational |
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| Enrollment | 438 (Actual) |
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| Sponsor | Eisai Co., Ltd. (Industry) |
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| Conditions | Insomnia |
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| Interventions | Eszopiclone (Drug) |
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| Dates | start 2012-10-01, primary completion 2015-03-30, completion 2015-12-22, first posted 2015-05-27, last updated 2018-09-07 |
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| Locations | 2 sites in Japan |
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Related Papers Related Patents Related Grants Related Experts
All trials for Insomnia All trials of Eszopiclone
-Summary
To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Participants with insomnia | | Drug: Eszopiclone | Participants with insomnia who will receive eszopiclone per approved label. |
- Eszopiclone (Drug), also known as 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.
+Outcome measures
Primary outcomes
- Assessment of overall improvement [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 [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) [Up to 6 months]
+Eligibility
Sex: All
Inclusion Criteria:
1\. Participants who have completed LUN01S and need to continue eszopiclone
+Locations (2)
| Facility | City | Country | Status |
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| Osaka | Japan | |
| Tokyo | Japan | |
+Publications
- Results publication: Japanese Journal of Sleep Medicine 11: 81-94, 2017.
+Investigators
- Akira Endo, Study director, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.