Treatment of Insomnia in Migraineurs

Last updated: May 19, 2023
Sponsor: MedVadis Research Corporation
Overall Status: Completed

Phase

4

Condition

Insomnia

Oral Facial Pain

Pain

Treatment

eszopiclone

placebo

Clinical Study ID

NCT00812214
ESRC024
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Men and women, 18 to 64 years of age (inclusive) with International Headache Society (IHS)-II migraine with/without aura and Diagnostic and Statistical Manual (DSM)-IVprimary insomnia (sleep onset/sleep maintenance).
  2. Migraine frequency is 4-12 times per month, with a maximum of 20 days with headacheper month, for 1 month or longer prior to screening.
  3. A usual, estimated total sleep time of 6½ hours per night or less, for 1 month orlonger prior to screening, due to problems falling asleep, waking up during the night,or waking up early.

Exclusion

Exclusion criteria:

  1. Abortive migraine treatment with schedule II-III opioids.
  2. Use of caffeine-containing medications, prescription and non-prescription, notexceeding 10 days per month.
  3. Preventive migraine treatment with tricyclics or anticonvulsants.
  4. Treatment of insomnia with non-prescription medications, such as diphenhydramine,melatonin, or valerian, and prescription medications, such as hypnotics, barbiturates,benzodiazepines, sedating antihistamines, antidepressants, and antipsychotics.

Study Design

Total Participants: 113
Treatment Group(s): 2
Primary Treatment: eszopiclone
Phase: 4
Study Start date:
April 01, 2007
Estimated Completion Date:
September 30, 2008

Study 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.