A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine (NCT00644033) | Clinical Trial Compass
CompletedPhase 3
A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine
United States579 participantsStarted 2001-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of menstrually associated migraine (MAM) headache in the treated peri-menstrual period (PMP)
Trial details
NCT IDNCT00644033
SponsorEndo USA Inc., a Keenova Therapeutics Company