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Sponsors and Collaborators: |
Thomas Jefferson University Endo Pharmaceuticals |
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Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00440232 |
We are testing the hypothesis that subjects in the treatment group will experience fewer fasting induced headaches as compared to those in the placebo group.In our clinical experience, we estimate that approximately 25% of our headache population experiences fasting-induced migraine or hunger-induced migraine. With a given migraine incidence of 28 million in the United States alone, we estimate that approximately 7 million will experience hunger as a migraine trigger. If an individual has a known migraine trigger, then there are a variety of ways to modify care in order to address that trigger. The simplest is to avoid that trigger or preemptively treat that trigger. Frovatriptan has good evidence for daily use for a short time to help prevent menstrually related migraines. A short course of treatment can often avoid the initiation of the migraine and improve quality of life. Knowing that a longer acting triptan, such as frovatriptan, has demonstrated capability at suppressing headache through a known trigger, suggests the need to study this with fasting induced migraines, as well.
Condition | Intervention |
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Migraine |
Drug: Frovatriptan |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Trial Examining the Safety and Efficacy of Frovatriptan as a Preemptive Treatment for Fasting-Induced Migraine Headache |
Estimated Enrollment: | 80 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
EXCLUSION CRITERIA
Contact: Meryl Latsko, MD, MPH | 215-955-9477 | meryl.latsko@jefferson.edu |
United States, Pennsylvania | |
Jefferson Headache Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Kathleen C Bradley, RN, BSN, CCRC 215-955-2025 kathleen.bradley@jefferson.edu | |
Principal Investigator: Stephen D. Silberstein, MD |
Principal Investigator: | Stephen D. Silberstein, M.D. | Thomas Jefferson University |
Study ID Numbers: | SDS/FHA-FRV/ 01 |
Study First Received: | February 22, 2007 |
Last Updated: | February 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00440232 |
Health Authority: | United States: Institutional Review Board |
Frovatriptan Migraine Disorders Headache Central Nervous System Diseases |
Headache Disorders, Primary Brain Diseases Serotonin Headache Disorders |
Serotonin Agonists Neurotransmitter Agents Serotonin Agents Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Nervous System Diseases Pharmacologic Actions |