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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches|
- Statistically significant reduction in migraine headaches in the Rozerem treated group. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Improvement in sleep satisfaction in the Rozerem treated group. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
ramelteon 8 mg po qhs with sleep and migraine journal
Other Name: Rozerem
Placebo Comparator: 2
Placebo po qhs with sleep and migraine journal
Other Name: Rozerem
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.
|United States, Virginia|
|Patricia Shipley, MD|
|Charlottesville, Virginia, United States, 22902|
|Principal Investigator:||Patricia J Shipley, MD||Charlottesville Neuroscience|