Treatment of Insomnia in Migraineurs

Phase 4

Completed

• Conditions: Insomnia; Migraine
• Interventions: Drug: placebo; Drug: eszopiclone

• Registration Number: NCT00812214
• Lead Sponsor: MedVadis Research Corporation

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.

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Results First Submitted: 2012-04-19
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Results First Posted: 2023-06-15
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Eszopiclone (Lunesta) 3mg	eszopiclone	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.

Primary Outcome Measures

Name	Time	Method
Total Sleep Time	Baseline, 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Headache Duration	Baseline, 6 weeks	Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period
Nighttime Awakenings	Measured every two weeks (1&2, 3&4, 5&6)	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
Daytime Fatigue	Measured every two weeks (1&2, 3&4, 5&6)	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
Headache Intensity	Baseline, 6 weeks	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
Quality of Sleep	Baseline, 6 weeks	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.
Headache Frequency	Baseline, 6 weeks	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