NCT00644033|CompletedPhase 3
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Sponsor study identifier
interventional
579
1 country
1
Study Start
June 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2002
Actual (reported)Study Completion
June 2002
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2002
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2001
Date type not reportedThis date has not been verified as actual or estimated.
June 2002
Actual (reported)June 2002
Actual (reported)March 24, 2008
Actual (reported)March 26, 2008
Actual (reported)Incidence of menstrually associated migraine (MAM) headache in the treated peri-menstrual period (PMP)
Incidence of moderate or severe MAM headaches
Incidence of severe MAM headaches
Duration of MAM headaches
Maximum headache intensity
Incidence of MAM headache associated symptoms and characteristics
2.5 mg tablet administered once daily for 6 days starting 2 days before the anticipated onset of a MAM headache
2.5 mg tablet administered twice daily for 6 days, starting 2 days before the anticipated onset of a MAM headache.
Endo Pharmaceuticals
Chadds Ford, Pennsylvania, 19317, United States
Silberstein SD, Berner T, Tobin J, Xiang Q, Campbell JC. Scheduled short-term prevention with frovatriptan for migraine occurring exclusively in association with menstruation. Headache. 2009 Oct;49(9):1283-97. doi: 10.1111/j.1526-4610.2009.01509.x. Epub 2009 Sep 14.
Arthur Elkind, MD
Elkind Headache Center
579 participants (actual enrollment reported by the registry).
First Submitted
March 24, 2008
First Posted
March 26, 2008
Study Start
June 2001
Date type not reportedThis date has not been verified as actual or estimated.
placebo tablet administered for 6 days, starting 2 days before the anticipated onset of a MAM headache.
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Primary Completion
June 2002
Actual (reported)Study Completion
June 2002
Actual (reported)Last Updated
January 2, 2024
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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