NCT00812214

Treatment of Insomnia in Migraineurs

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: MedVadis Research Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of the study is to determine the effect of prolonging total sleep time in migraineurs with insomnia on overall headache frequency, daytime alertness, fatigue, and functioning. The prolongation of total sleep time is accomplished by bedtime administration of 3 mg eszopiclone (Lunesta™), compared with placebo through a parallel-group design.

Conditions

• Insomnia
• Migraine

Interventions

Type	Name	Description
DRUG	eszopiclone	3 mg tablet every night at bedtime
DRUG	placebo	1 tablet every night at bedtime

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-12-22
• Last updated: 2023-06-15
• Results posted: 2023-06-15