Treatment of Insomnia in Migraineurs

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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 day2, undoubtedly affecting daytime functioning, which is hypothesized to improve as well with prolonged total sleep time.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedVadis Research Corporation
• Collaborator: Sepracor Incorporated, 84 Waterford Drive, Marlborough, MA 01752
• Treatments: Eszopiclone

Criteria

Subjects included in the study are men and women, 18 to 64 years of age (inclusive), with IHS-II migraine with/without aura and DSM-IV primary insomnia (sleep onset/sleep maintenance). The required migraine frequency is 4-12 times per month, with a maximum of 20 days with headache per month, for 1 month or longer prior to screening. The requirement with regard to insomnia is a usual, estimated total sleep time of 6½ hours per night or less, for 1 month or longer prior to screening, due to problems falling asleep, waking up during the night, or waking up early. The sleep and headache eligibility criteria are confirmed at the randomization visit on the basis of the daily diary.