Clinical trial NCT00812214: Treatment of Insomnia in Migraineurs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Migraine
Keywords: insomnia
migraine
eszopiclone
insomnia in migraineurs
Lead sponsor: MedVadis Research Corporation
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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)-IV primary insomnia (sleep onset/sleep maintenance).
2. 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.
3. 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.

Exclusion criteria:

1. Abortive migraine treatment with schedule II-III opioids.
2. Use of caffeine-containing medications, prescription and non-prescription, not exceeding 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.

Primary outcomes:
measure: Total Sleep Time
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Nighttime Awakenings
timeFrame: Baseline, 6 weeks
measure: Nighttime Awakenings
timeFrame: Measured every two weeks (1&2, 3&4, 5&6)
measure: Quality of Sleep
timeFrame: Baseline, 6 weeks
measure: Daytime Fatigue
timeFrame: Measured every two weeks (1&2, 3&4, 5&6)
measure: Headache Frequency
timeFrame: Baseline, 6 weeks
measure: Headache Duration
timeFrame: Baseline, 6 weeks
measure: Headache Intensity
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: MedVadis Research Corporation
name: Egilius LH Spierings, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spierings EL, McAllister PJ, Bilchik TR. Efficacy of treatment of insomnia in migraineurs with eszopiclone (Lunesta(R)) and its effect on total sleep time, headache frequency, and daytime functioning: A randomized, double-blind, placebo-controlled, parallel-group, pilot study. Cranio. 2015 Apr;33(2):115-21. doi: 10.1179/0886963414Z.00000000084. Epub 2014 Oct 16.