A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches

Study Overview
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Brief Summary
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To study the effect of Rozerem, a high affinity MT1 and MT2, low affinity 5-HT2B receptor agonist used for insomnia, as a migraine prophylactic agent.

Detailed Description
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In a recent, large study of migraineurs, over half reported difficulties with sleep initiation or maintenance. Those who had shorter average sleep times reported more severe headaches. Poor sleep has been associated with increased frequency and severity of migraines. The improvement of migraine frequency with improved sleep hygiene has been documented. PET imaging has shown increased regional cerebral blood flow to neural structures involved in the sleep wake cycle during migraine headaches. Polysomnography has shown specific headache types to occur in specific sleep stages. Melatonin has been effective primarily in headache due to delayed sleep phase syndrome. Recent studies support the efficacy of melatonin in treating migraine. The purpose of this study is to examine the efficacy of Rozerem as a prophylactic migraine medication. If effective, the benefits of the drug as a prophylactic agent for migraine include the tolerability of the drug and the possible secondary benefit of improvement in sleep. Hypothesis: Rozerem will decrease migraine frequency due to the improvement in sleep and possibly due to the shared neurophysiology of sleep and migraine affected by melatonin.

Official Title
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A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches

Conditions
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Migraine Headache

Intervention / Treatment
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* Drug: ramelteon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 3-8 Migraine headaches/month Able to understand and comply with the study Exclusion Criteria: Currently on migraine prophylaxis Currently on sleep medication > 4days/month Currently on Fluvoxamine Untreated psychiatric or sleep disorders MRI abnormalities other than those attributable to migraine headaches Abnormalities on neurological exam other than known neurological disorders unassociated with migraine or sleep Known disorders of prolactin Bipolar disorder Hepatic disease Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ramelteon 8 mg po qhs with sleep and migraine journal | Drug: ramelteon<br>* ramelteon 8mg po qhs with sleep and headache diary placebo 1 po qhs with sleep and headache diary<br>* Other names: Rozerem;|
| Placebo Comparator: 2<br>Placebo po qhs with sleep and migraine journal | Drug: ramelteon<br>* ramelteon 8mg po qhs with sleep and headache diary placebo 1 po qhs with sleep and headache diary<br>* Other names: Rozerem;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistically significant reduction in migraine headaches in the Rozerem treated group. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in sleep satisfaction in the Rozerem treated group. |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine Headache