A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
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|ClinicalTrials.gov Identifier: NCT00391755|
Recruitment Status : Terminated (Failure to recruit necessary number of patients.)
First Posted : October 24, 2006
Last Update Posted : February 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache||Drug: ramelteon||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches|
|Study Start Date :||October 2006|
|Primary Completion Date :||October 2009|
|Study Completion Date :||October 2009|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391755
|United States, Virginia|
|Patricia Shipley, MD|
|Charlottesville, Virginia, United States, 22902|
|Principal Investigator:||Patricia J Shipley, MD||Charlottesville Neuroscience|