CompletedPhase 3

Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches

Germany, Hungary, Poland550 participantsStarted 2003-12

Plain-language summary

In this open-label, multi-center study, patients were treated with frovatriptan for a maximum of 12 perimenstrual periods (PMPs). For each PMP, dosing commenced 2 days before the anticipated onset of the menstrual migraine (MM) headache and continued for a total of 6 days. Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6. During the study, patients were to visit the study site a total of 6 times. Efficacy and/or safety assessments were performed at each visit.

Who can participate

Age range

15 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: * Female aged 15 years and over (≥18 years in United Kingdom and South Africa), with at least a 12 month documented history of experiencing migraine according to IHS criteria, including confirmation of a 3 month diary based documented history of MAM. * An average frequency of MAM in at least two out of three menstrual cycles, within the previous 12 months * Regular, predictable menstrual periods * MAM headaches occurring between Day -2 and day +4 of menses * Able and willing to sign informed consent and to comply with study procedures, including completion of the diary cards. Exclusion Criteria: * More than three migraine attacks per month that were not MAM attacks * A history of myocardial infarction, ischemic heart disease (or presenting with symptoms or signs compatible with ischemic heart disease), coronary vasospasm or peripheral vascular disease * Significant cerebrovascular disease including basilar or hemiplegic migraine * Uncontrolled hypertension (SBP \>180 mmHg, DBP \>95 mmHg) * Severe hepatic or renal insufficiency * More than 15 headache days per month, exclusive of migraine headache * Any other condition or serious illness which, in the opinion of the investigator, would interfere with optimal participation in the study * A history of clinically relevant allergy, including that to frovatriptan or other triptans * Pregnant or breast-feeding, or intending to become pregnant or breast-feed during the study period (patients were to be using ad…

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

Incidence of all treatment-emergent adverse events (AEs).

Timeframe: 9-15 months

Trial details

NCT IDNCT01035983

SponsorEndo USA Inc., a Keenova Therapeutics Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-06

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