Treatment of Insomnia in Migraineurs

This study has been completed.
Sponsor:
Collaborator:
Sepracor Incorporated, 84 Waterford Drive, Marlborough, MA 01752
Information provided by:
MedVadis Research Corporation
ClinicalTrials.gov Identifier:
NCT00812214
First received: December 18, 2008
Last updated: December 19, 2008
Last verified: December 2008
  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

Resource links provided by NLM:


Further study details as provided by MedVadis Research Corporation:

Primary Outcome Measures:
  • Total sleep time [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

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 August 28, 2014