NCT00644033

A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 579 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Menstrually Associated Migraine

Interventions

Type	Name	Description
DRUG	Frovatriptan	2.5 mg tablet administered once daily for 6 days starting 2 days before the anticipated onset of a MAM headache
DRUG	Frovatriptan	2.5 mg tablet administered twice daily for 6 days, starting 2 days before the anticipated onset of a MAM headache.
DRUG	Placebo	placebo tablet administered for 6 days, starting 2 days before the anticipated onset of a MAM headache.

Timeline

• Start date: 2001-06-01
• Primary completion: 2002-06-01
• Completion: 2002-06-01
• First posted: 2008-03-26
• Last updated: 2024-01-02

Locations

1 site across 1 country: United States