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OpenTrials
Completed

NCT Number: NCT00812214

Treatment of Insomnia in Migraineurs

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.

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Key information

Conditions

Insomnia Brain Diseases Central Nervous System Diseases Dyssomnias Headache Disorders Headache Disorders, Primary Mental Disorders Migraine Migraine Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eszopiclone

Drug

3 mg tablet every night at bedtime

Other names: Lunesta

Placebo

Drug

1 tablet every night at bedtime

Primary outcomes

  1. Total Sleep Time

    Time frame: 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 outcomes

  1. Nighttime Awakenings

    Time frame: Baseline, 6 weeks

    Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period

  2. Nighttime Awakenings

    Time frame: 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

  3. Quality of Sleep

    Time frame: 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.

  4. Daytime Fatigue

    Time frame: 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

  5. Headache Frequency

    Time frame: 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

  6. Headache Duration

    Time frame: Baseline, 6 weeks

    Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period

  7. Headache Intensity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

MedVadis Research Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 22, 2008
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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