Treatment of Insomnia in Migraineurs

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Insomnia
• Intervention / Treatment: Drug: eszopiclone; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eszopiclone (Lunesta) 3mg; 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; 3 mg tablet every night at bedtime; Other Names: Lunesta
Placebo Comparator: Placebo; 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; 1 tablet every night at bedtime

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: MedVadis Research Corporation
• Collaborators: Sepracor Incorporated, 84 Waterford Drive, Marlborough, MA 01752
• Investigators: Principal Investigator: Egilius LH Spierings, M.D., Ph.D., MedVadis Research Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: December 18, 2008
• First Submitted That Met QC Criteria: December 19, 2008
• First Posted (Estimated): December 22, 2008

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: insomnia; migraine; eszopiclone; insomnia in migraineurs
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Eszopiclone
• Other Study ID Numbers: ESRC024