Treatment of Insomnia in Migraineurs

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812214
• Other study ID #: ESRC024
• Status: Completed
• Phase: Phase 4
• Start date: April 2007
• Est. completion date: September 2008

Study information

• Verified date: May 2023
• Source: MedVadis Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Migraine
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• eszopiclone
3 mg tablet every night at bedtime
• placebo
1 tablet every night at bedtime

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MedVadis Research Corporation

References & Publications (1)

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, parall — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nighttime Awakenings	Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period	Baseline, 6 weeks
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	Headache Duration	Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period	Baseline, 6 weeks
Secondary	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