A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine
Status:
Completed
Trial end date:
2002-06-01
Target enrollment:
Participant gender:
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.