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Sponsors and Collaborators: |
Endo Pharmaceuticals Vernalis LTD |
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Information provided by: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00644033 |
The primary objective of this study was to determine whether frovatriptan was effective in the prevention of menstrually associated migraine (MAM) headaches when compared to placebo. Secondary objectives included determining the effectiveness of frovatriptan in reducing the incidence, severity and duration of MAM headaches and associated symptoms, to evaluate the safety and tolerability of the two frovatriptan dosing regimens and to compare the effectiveness of these regimens in the prevention of MAM headaches. In this cross-over study, patients treated each of 3 perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg daily (QD) and 2.5 mg twice daily (BID) for 6 days, starting 2 days before the anticipated onset of a MAM headache.
A statistically significant reduction in the incidence of MAM headache (p<0.0001) was observed with both dosing regimens of frovatriptan when compared to placebo. Additionally, the frovatriptan BID regimen was superior to the frovatriptan QD regimen in the prevention of MAM headache (p<0.001). Significant reductions in MAM headache severity and duration, the incidence of associated symptoms and characteristics, and the use of rescue medication were observed when the PMP was treated with frovatriptan, compared to placebo. Both dose regimens of frovatriptan were equally well tolerated and no cardiovascular or other safety and tolerability concerns arose with repeated administration of frovatriptan over a 6 day period.
Condition | Intervention | Phase |
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Menstrually Associated Migraine |
Drug: Frovatriptan Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Enrollment: | 579 |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Frovatriptan
2.5 mg tablet administered once daily for 6 days starting 2 days before the anticipated onset of a MAM headache
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2: Active Comparator |
Drug: Frovatriptan
2.5 mg tablet administered twice daily for 6 days, starting 2 days before the anticipated onset of a MAM headache.
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3: Placebo Comparator |
Drug: Placebo
placebo tablet administered for 6 days, starting 2 days before the anticipated onset of a MAM headache.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Endo Pharmaceuticals | |
Chadds Ford, Pennsylvania, United States, 19317 |
Principal Investigator: | Arthur Elkind, MD |
Responsible Party: | Endo Pharmaceuticals ( John C. Campbell, Director, Medical Affairs ) |
Study ID Numbers: | VML 251 00/02 |
Study First Received: | March 24, 2008 |
Last Updated: | March 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00644033 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Serotonin Agonists Neurotransmitter Agents Frovatriptan Migraine Disorders Headache |
Central Nervous System Diseases Headache Disorders, Primary Brain Diseases Serotonin Headache Disorders |
Serotonin Agonists Neurotransmitter Agents Frovatriptan Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Central Nervous System Diseases |
Headache Disorders, Primary Brain Diseases Pharmacologic Actions Headache Disorders Serotonin Agents Migraine Disorders |