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Treatment of Insomnia in Migraineurs

NCT00812214·ClinicalTrials.gov

What this study is about

Take this into the appointment.

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Keep this study

Lead

MedVadis Research Corporation

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.

Age

18–65

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

1. Men and women, 18 to 64 years of age (inclusive) with International Headache Society (IHS)-II migraine with/without aura and Diagnostic and Statistical Manual (DSM)-IV primary insomnia (sleep onset/sleep maintenance).
2. 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.
3. 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.

You may not be if

1. Abortive migraine treatment with schedule II-III opioids.
2. Use of caffeine-containing medications, prescription and non-prescription, not exceeding 10 days per month.
3. Preventive migraine treatment with tricyclics or anticonvulsants.
4. Treatment of insomnia with non-prescription medications, such as diphenhydramine, melatonin, or valerian, and prescription medications, such as hypnotics, barbiturates, benzodiazepines, sedating antihistamines, antidepressants, and antipsychotics.

The record

StatusCompleted

PhasePhase 4

Taking part113

StartedApr 2007

UpdatedJun 15, 2023

Conditions

Insomnia Migraine