CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 369 enrolled
Drug / intervention
Eszopiclone 1 mg- Elderly +3 moredrug
Likely dose
Eszopiclone 1 mg- Elderlyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00770692
NCT00770692Phase 3Completed
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A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia

Eisai Co., Ltd.·interventional·Posted Oct 10, 2008·Updated Nov 22, 2012

In Brief

A Phase 3 clinical trial evaluating Eszopiclone 1 mg- Elderly, Eszopiclone 2 mg- Elderly, and 2 other interventions for Insomnia. Completed, enrolled 369 participants across 34 sites.

Detailed Summary

The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2008
Enrollment StartOct 1, 2008
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.7 years ago

Interventions

Eszopiclone 1 mg- Elderlydrug

Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.

Eszopiclone 2 mg- Elderlydrug

Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.

Eszopiclone 3 mg- Non-elderlydrug

Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.

Eszopiclone 2 mg- Non-elderlydrug

Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.