Treatment of Insomnia in Migraineurs
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 day2, undoubtedly affecting daytime functioning, which is hypothesized to improve as well with prolonged total sleep time.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||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|
- Total sleep time [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- headache days [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
3 mg qhs
|Placebo Comparator: 2||Drug: placebo|
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.
|Principal Investigator:||Egilius L.H. Spierings, M.D., Ph.D.||MedVadis Research Corporation|