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Sponsors and Collaborators: |
Swedish Medical Center Takeda Global Research & Development Center, Inc. |
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Information provided by: | Swedish Medical Center |
ClinicalTrials.gov Identifier: | NCT00739024 |
The purpose of this study is to see if ramelteon will reduce the number of migraine headaches over a 12 week period. The safety and tolerability of ramelteon will also be evaluated. Ramelteon has been approved by the U.S. Food and Drug Administration (FDA) for insomnia (trouble sleeping); however; ramelteon has not been approved for the prevention of migraines.
Condition | Intervention | Phase |
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Migraine Migraine With Aura Migraine Without Aura |
Drug: ramelteon |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Placebo-Controlled, Parallel Group Study to Study the Efficacy and Tolerability of Ramelteon (Rozerem) in the Prophylaxis of Migraine |
Estimated Enrollment: | 30 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Sleep has played an important role in migraine. Younger migraine sufferers usually report relief of migraine after sleep. In older migraine sufferers migraine is sometimes triggered with sleep changes. Occurrence of migraine in the early morning is very common. Therefore in these individuals regulation of sleep may improve the frequency of migraine. Recent PET studies done during migraine demonstrated activation of hypothalamus during migraine. In light of this new data and the known action of ramelteon on the melatonin receptors it may theoretically provide an insight on a possible mechanism of action in migraine.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patricia M Barrodale, RN | 206-215-3502 | pat.barrodale@swedish.org |
Contact: Reda L Tipton | 206-386-3806 | reda.tipton@swedish.org |
United States, Washington | |
Swedish Pain and Headache Center | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Patricia M Barrodale, RN 206-215-3502 pat.barrodale@swedish.org | |
Principal Investigator: Sheena K Aurora, MD |
Principal Investigator: | Sheena K Aurora, MD | Swedish Medical Center |
Responsible Party: | Swedish Medical Center ( Sheena K. Aurora, MD ) |
Study ID Numbers: | CRC 0690 |
Study First Received: | August 19, 2008 |
Last Updated: | January 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00739024 History of Changes |
Health Authority: | United States: Institutional Review Board |
Migraine Headache |
Migraine Disorders Headache Central Nervous System Diseases Melatonin Headache Disorders, Primary |
Migraine with Aura Brain Diseases Headache Disorders Migraine without Aura |
Migraine Disorders Nervous System Diseases Central Nervous System Diseases Headache Disorders, Primary |
Migraine with Aura Brain Diseases Headache Disorders Migraine without Aura |