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Treatment of Insomnia in Migraineurs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00812214
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : December 22, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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 day2, undoubtedly affecting daytime functioning, which is hypothesized to improve as well with prolonged total sleep time.

Condition or disease Intervention/treatment Phase
Insomnia Migraine Drug: eszopiclone Drug: placebo Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2007
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
Drug Information available for: Eszopiclone
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: eszopiclone
3 mg qhs
Placebo Comparator: 2 Drug: placebo


Outcome Measures

Primary Outcome Measures :
  1. Total sleep time [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. headache days [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812214


Sponsors and Collaborators
MedVadis Research Corporation
Sepracor Incorporated, 84 Waterford Drive, Marlborough, MA 01752
Investigators
Principal Investigator: Egilius L.H. Spierings, M.D., Ph.D. MedVadis Research Corporation
More Information

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
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: December 22, 2008
Last Verified: December 2008

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 Wake Disorders
Mental Disorders
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs