CompletedPhase 3

Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

United States351 participantsStarted 2006-05

Plain-language summary

This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.

Who can participate

Age range

18 Years – 65 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: * At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month * Typically experiences moderate to severe migraine pain preceded by a mild pain phase * Differentiate between mild migraine pain and other headache types * Women of childbearing potential must be on adequate contraception Exclusion Criteria: * Pregnant and/or nursing mother * History of cardiovascular disease * Uncontrolled hypertension * Basilar or Hemiplegic migraine * History of stroke or transient ischemic attacks (TIA) * History of epilepsy or treated with anti-epileptics within past 5 years * Impaired hepatic or renal function * History of gastrointestinal bleeding or ulceration * Allergy or hypersensitivity to aspirin or any other NSAID * Allergy or hypersensitivity to triptans * Participated in an investigational drug trial in the previous 4 weeks

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

Score on a 4-pt migraine pain scale for a single menstrual migraine attack

Timeframe: 2 to 48 hours

Trial details

NCT IDNCT00329355

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-11

View on ClinicalTrials.gov More Migraine trials