CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
eszopiclone +1 moredrug
Likely dose
eszopiclone 3mgfrom 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/NCT00555750
NCT00555750N/ACompleted
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The Effects of Eszopiclone Treatment (3mg for Two Months) to Counteract the Adverse Metabolic Consequences of Primary Insomnia

Brigham and Women's Hospital·interventional·Posted Nov 9, 2007·Updated Dec 10, 2013

In Brief

A clinical study evaluating eszopiclone and placebo for Primary Insomnia. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U.S. Food and Drug Administration (FDA) for sale for the treatment of insomnia. It is marketed in the United States as LUNESTA. Main Hypothesis: Primary insomnia is associated with impairments of glucose metabolism that can be reversed by two months of eszopiclone for the primary insomnia

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Insomnia
CountriesUnited States
CollaboratorsSumitomo Pharma America, Inc., Mclean Hospital, National Center for Research Resources (NCRR)

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2007
Enrollment StartMar 1, 2006
Primary CompletionJul 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.6 years ago

Interventions

eszopiclonedrug

3mg tablet, by mouth nightly 30 min before bed, for two months

placebodrug

inactive placebo tablet, by mouth nightly 30 minutes before bed, for two months