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Sponsored by: |
Endo Pharmaceuticals |
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Information provided by: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00475514 |
Although the predictability of an MRM headache attack lends itself to preventative treatment, there are currently no drugs specifically indicated for the prevention of MM. Such preventative therapies might be administered either short term (during the time around the period otherwise known as the peri-menstrual period or PMP) or continuously throughout the menstrual cycle.
Frovatriptan has been developed for the management of migraine and is already licensed for use as an acute treatment for this condition. Previous well controlled clinical trials have highlighted the potential of frovatriptan as a short-term preventative medication for MM. This clinical trial was meant to further explore this indication for frovatriptan in an expanded population.
Condition | Intervention | Phase |
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Migraine |
Drug: Frovatriptan 2.5mg QD Drug: Frovatriptan 2.5 mg BID Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | A Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, and Safety of Oral Frovatriptan in the Prevention on Menstrually-Related Migraine (MRM) Headaches in a ‘Difficult to Treat’ Population |
Study Start Date: | October 2004 |
Study Completion Date: | April 2006 |
See above
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study ID Numbers: | VML 251-3MRM02 |
Study First Received: | May 16, 2007 |
Last Updated: | May 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00475514 |
Health Authority: | United States: Food and Drug Administration |
Menstrually-related Migraine Headache ‘Difficult to Treat’ as specified in protocol |
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 |