At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 113 enrolled
Drug / intervention
eszopiclone +1 moredrug
Likely dose
eszopiclone 3 mgfrom 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.
Treatment of Insomnia in Migraineurs With Eszopiclone (Lunesta™) and Its Effect on Sleep Time, Headache Frequency, and Daytime Functioning: a Randomized, Double-blind, Placebo-controlled, Parallel-group Pilot Study
In Brief
A Phase 4 clinical trial evaluating eszopiclone and placebo for Insomnia and Migraine. Completed, enrolled 113 participants.
Detailed Summary
It is hypothesized that treating insomnia in migraineurs, many of whom also have tension headaches, prolongs total sleep time to the extent that it decreases overall headache frequency. Chronic headache sufferers also feel more tired during the day, undoubtedly affecting daytime functioning, which is hypothesized to improve as well with prolonged total sleep time.
Study Details
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
Primary CompletionSep 2008
First PostedDec 2008
TodayJul 2026
First PostedDec 22, 2008
Enrollment StartApr 1, 2007
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.5 years ago
Interventions
eszopiclonedrug
3 mg tablet every night at bedtime
placebodrug
1 tablet every night at bedtime