Treatment of Insomnia in Migraineurs
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Purpose
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 day2, undoubtedly affecting daytime functioning, which is hypothesized to improve as well with prolonged total sleep time.
| Condition | Intervention | Phase |
|---|---|---|
|
Insomnia Migraine |
Drug: eszopiclone Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| 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 |
- Total sleep time [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- headache days [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 113 |
| Study Start Date: | April 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: eszopiclone
3 mg qhs
|
| Placebo Comparator: 2 | 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Subjects included in the study are men and women, 18 to 64 years of age (inclusive), with IHS-II migraine with/without aura and DSM-IV primary insomnia (sleep onset/sleep maintenance). The required 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. The requirement with regard to insomnia is 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. The sleep and headache eligibility criteria are confirmed at the randomization visit on the basis of the daily diary.
Contacts and Locations| Principal Investigator: | Egilius L.H. Spierings, M.D., Ph.D. | MedVadis Research Corporation |
More Information
No publications provided
| Responsible Party: | Egilius L.H. Spierings, M.D., Ph.D., Medvadis Research Corporation |
| ClinicalTrials.gov Identifier: | NCT00812214 History of Changes |
| Other Study ID Numbers: | ESRC024 |
| Study First Received: | December 18, 2008 |
| Last Updated: | December 19, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by MedVadis Research Corporation:
|
insomnia migraine eszopiclone insomnia in migraineurs |
Additional relevant MeSH terms:
|
Migraine Disorders Sleep Initiation and Maintenance Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Mental Disorders Eszopiclone Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013