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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

December 18, 2008
December 19, 2008
April 2007
September 2008   (final data collection date for primary outcome measure)
Total sleep time [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00812214 on ClinicalTrials.gov Archive Site
headache days [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Insomnia in Migraineurs
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
  • Insomnia
  • Migraine
  • Drug: eszopiclone
    3 mg qhs
  • Drug: placebo
  • Experimental: 1
    Intervention: Drug: eszopiclone
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
September 2008
September 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00812214
ESRC024
No
Egilius L.H. Spierings, M.D., Ph.D., Medvadis Research Corporation
MedVadis Research Corporation
Sepracor Incorporated, 84 Waterford Drive, Marlborough, MA 01752
Principal Investigator: Egilius L.H. Spierings, M.D., Ph.D. MedVadis Research Corporation
MedVadis Research Corporation
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP