Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study (NCT01986088) | Clinical Trial Compass
CompletedPhase 3
Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study
1,008 participantsStarted 1996-11
Plain-language summary
A previously published, placebo-controlled, head-to-head comparator study found eletriptan to have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack. The goal of the current study was to extend the findings of that study by examining the efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to evaluate the comparative efficacy of eletriptan and sumatriptan across additional important clinical outcomes. In particular, early response (at 1 hour), sustained response (without need for additional treatment) at 24 hours, and consistency of response across multiple attacks were examined.
Who can participate
Age range
18 Years – 76 Years
Sex
ALL
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:
* Eligible patients were men and women with a minimum age limit of 18 years of age (in Canada there was also an age limit of 65 years) who were expected to have at least one attack of migraine with or without aura, as defined by the International Headache Society (IHS) criteria,15 every 6 weeks.
* Patients had to be capable of taking study medication as outpatients and recording the effects.
Exclusion Criteria:
* Pregnant or breast-feeding women and those not using adequate contraception were excluded from the trial.
* Patients with frequent nonmigrainous headache, atypical migraine that had not previously responded to therapy, migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, or migrainous infarction were excluded from the trial.
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.
1This trial compared eletriptan and sumatriptan head-to-head for migraine relief — can you tell me how these two medications compare in terms of how well they worked at the one-hour mark, which is what the study was focused on measuring?
2Since this was a Phase 3 trial that has already been completed, does the available safety and effectiveness data suggest that either eletriptan or sumatriptan might be a better fit for my specific migraine pattern, whether I get aura or not?
3The study used a placebo group alongside the two active treatments — what does that tell us about how much better these medications performed compared to taking nothing, and is that difference meaningful for someone in my situation?
4Given that this trial involved treating multiple migraine attacks over time rather than just one, does the data say anything about how consistent the relief was across repeated use, and is that something I should factor into my treatment decision?
5Are there standard migraine treatments I should consider trying first before we discuss whether the findings from a completed trial like this one are relevant to my care??
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
Headache response at 1 hour after treatment of the first attack.
Timeframe: 1 hour
Trial details
NCT IDNCT01986088
SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.