Migraine Headache Clinical Trial
Official title:
A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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