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

    Phase 3
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    frovatriptan ...
  • Study Participants

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.
Study Started
Jun 30
Primary Completion
Jun 30
Study Completion
Jun 30
Last Update
Jun 14

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.

1 Active Comparator

2 Active Comparator

3 Placebo Comparator


Inclusion Criteria:

Females aged 18 years and over
12 month or more documented history of menstrual migraine headache, according to International Headache Society classification
An average frequency of MAM attacks in at lease 3 out of 4 menstrual cycles
Regular predictable menstrual periods
Able to accurately predict the onset of MAM headaches occurring between Day -2 and Day +4 of menses
Able and willing to sign informed consent to comply with study procedures, including completion of diary cards

Exclusion Criteria:

More than three migraine attacks per month that were not MAM attacks
Coronary artery disease including coronary vasospasm
Significant cerebrovascular disease including basilar or hemiplegic migraine
Uncontrolled hypertension
Severe hepatic or renal insufficiency
More than 15 headache days per month
Any other condition or serious illness which would interfere with optimal participation in the study
History of clinically relevant allergy, including that to frovatriptan or other triptans
Pregnant or breast feeding or intending to become pregnant or to breast-feed during study period
Participated in other frovatriptan menstrual migraine prevention studies
Use of another investigation drug within 30 days or 5 half-lives (whichever is longer) before the screening visit
No Results Posted