- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00391755
A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Virginia
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Charlottesville, Virginia, United States, 22902
- Patricia Shipley, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
ramelteon 8 mg po qhs with sleep and migraine journal
|
Other Names:
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Placebo Comparator: 2
Placebo po qhs with sleep and migraine journal
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Statistically significant reduction in migraine headaches in the Rozerem treated group.
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in sleep satisfaction in the Rozerem treated group.
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patricia J Shipley, MD, Charlottesville Neuroscience
Publications and helpful links
General Publications
- Peres MF, Zukerman E, da Cunha Tanuri F, Moreira FR, Cipolla-Neto J. Melatonin, 3 mg, is effective for migraine prevention. Neurology. 2004 Aug 24;63(4):757. doi: 10.1212/01.wnl.0000134653.35587.24. No abstract available.
- Sahota PK, Dexter JD. Sleep and headache syndromes: a clinical review. Headache. 1990 Jan;30(2):80-4. doi: 10.1111/j.1526-4610.1990.hed3002080.x.
- Kelman L, Rains JC. Headache and sleep: examination of sleep patterns and complaints in a large clinical sample of migraineurs. Headache. 2005 Jul-Aug;45(7):904-10. doi: 10.1111/j.1526-4610.2005.05159.x.
- Boardman HF, Thomas E, Millson DS, Croft PR. Psychological, sleep, lifestyle, and comorbid associations with headache. Headache. 2005 Jun;45(6):657-69. doi: 10.1111/j.1526-4610.2005.05133.x.
- Bruni O, Galli F, Guidetti V. Sleep hygiene and migraine in children and adolescents. Cephalalgia. 1999 Dec;19 Suppl 25:57-9. doi: 10.1177/0333102499019s2516.
- Bahra A, Matharu MS, Buchel C, Frackowiak RS, Goadsby PJ. Brainstem activation specific to migraine headache. Lancet. 2001 Mar 31;357(9261):1016-7. doi: 10.1016/s0140-6736(00)04250-1.
- Peres MF. Melatonin, the pineal gland and their implications for headache disorders. Cephalalgia. 2005 Jun;25(6):403-11. doi: 10.1111/j.1468-2982.2005.00889.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-013R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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