A Phase 4 interventional study of ramelteon in Migraine Headache, sponsored by Charlottesville Neuroscience. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-10.
Sponsored by Charlottesville Neuroscience · Phase 4, Interventional, and Treatment
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.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 4 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →This is the only study on the registry with Charlottesville Neuroscience as lead sponsor.
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Exclusion Criteria:
ramelteon 8 mg po qhs with sleep and migraine journal
Drug: ramelteon
Placebo po qhs with sleep and migraine journal
Drug: ramelteon
1. ramelteon 8mg po qhs with sleep and headache diary 2. placebo 1 po qhs with sleep and headache diary
Also known as: Rozerem
Statistically significant reduction in migraine headaches in the Rozerem treated group.
Time frame: 4 months
Improvement in sleep satisfaction in the Rozerem treated group.
Time frame: 4 months
This study is terminated, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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