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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-10-31

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.

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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.

Conditions

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Migraine Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

ramelteon 8 mg po qhs with sleep and migraine journal

Group Type ACTIVE_COMPARATOR

ramelteon

Intervention Type DRUG

1. ramelteon 8mg po qhs with sleep and headache diary
2. placebo 1 po qhs with sleep and headache diary

2

Placebo po qhs with sleep and migraine journal

Group Type PLACEBO_COMPARATOR

ramelteon

Intervention Type DRUG

1. ramelteon 8mg po qhs with sleep and headache diary
2. placebo 1 po qhs with sleep and headache diary

Interventions

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ramelteon

1. ramelteon 8mg po qhs with sleep and headache diary
2. placebo 1 po qhs with sleep and headache diary

Intervention Type DRUG

Other Intervention Names

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Rozerem

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes