Treatment of Insomnia in Migraineurs

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Insomnia, Migraine

Intervention / Treatment
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* Drug: eszopiclone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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). 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. 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: Abortive migraine treatment with schedule II-III opioids. Use of caffeine-containing medications, prescription and non-prescription, not exceeding 10 days per month. Preventive migraine treatment with tricyclics or anticonvulsants. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eszopiclone (Lunesta) 3mg<br>Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit. | Drug: eszopiclone<br>* 3 mg tablet every night at bedtime<br>* Other names: Lunesta;|
| Placebo Comparator: Placebo<br>Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit. | Drug: placebo<br>* 1 tablet every night at bedtime<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time | Participants were asked to record an estimated total time asleep on a daily basis. Nightly estimates were averaged over a 2 week period for baseline and 6 week period so that the total sleep time represents the average total time asleep each night. | Baseline, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nighttime Awakenings | Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period | Baseline, 6 weeks | 
| Nighttime Awakenings | Participants were asked to keep a daily record. The average among weeks 1 and 2, weeks 3 and 4, and weeks 5 and 6 were taken, resulting in 3 averages, where the lowest average is reported as the minimum value of the full range, the middle average is reported as the median, and the highest average is reported as the maximum value of the full range | Measured every two weeks (1&2, 3&4, 5&6) | 
| Quality of Sleep | Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period Overall sleep quality was measured on a scale of 1=poor to 10=excellent. Daytime alertness was measured on a scale of 1=not alert to 10=extremely alert. Daytime fatigue was measured on a scale of 1=not tired to 10=extremely tired. Daytime functioning was measured on a scale of 1=poor to 10=excellent. | Baseline, 6 weeks | 
| Daytime Fatigue | Participants were asked to keep a daily record. Daytime fatigue was measured on a scale of 1=not tired to 10=extremely tired. The average among weeks 1 and 2, weeks 3 and 4, and weeks 5 and 6 were taken, resulting in 3 averages, where the lowest average is reported as the minimum value of the full range, the middle average is reported as the median, and the highest average is reported as the maximum value of the full range | Measured every two weeks (1&2, 3&4, 5&6) | 
| Headache Frequency | Number of days per week in which a participant had a headache. Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period | Baseline, 6 weeks | 
| Headache Duration | Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period | Baseline, 6 weeks | 
| Headache Intensity | Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period Headache intensity was measured on a scale of 1=not intense to 10=worst headache possible | Baseline, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, migraine, eszopiclone, insomnia in migraineurs