Migraine Headache
Conditions
Keywords
Migraine Headache
Brief summary
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.
Detailed description
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.
Interventions
DRUGramelteon
1. ramelteon 8mg po qhs with sleep and headache diary 2. placebo 1 po qhs with sleep and headache diary
Sponsors
Takeda Pharmaceuticals North America, Inc.
Charlottesville Neuroscience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Statistically significant reduction in migraine headaches in the Rozerem treated group. | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in sleep satisfaction in the Rozerem treated group. | 4 months |
Countries
United States
Outcome results
None listed