Treatment of Insomnia in Migraineurs

Sponsor

MedVadis Research Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00812214

Collaborator

Sepracor Incorporated, 84 Waterford Drive, Marlborough, MA 01752 (Other)

113

Enrollment

Arms

17.1

Duration (Months)

Study Details

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

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 :

Apr 1, 2007

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Drug: eszopiclone

3 mg qhs

Placebo Comparator: 2

Drug: placebo

Outcome Measures

Primary Outcome Measures

Total sleep time [6 weeks]

Secondary Outcome Measures

headache days [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.