Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study
- Conditions
- Migraine With or Without Aura
- Interventions
- Registration Number
- NCT01986088
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1008
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sumatriptan 50 mg Sumatriptan 50 mg - Placebo Placebo - Eletriptan 40 mg Eletriptan 40 mg - Eletriptan 80 mg Eletriptan 80 mg - Sumatriptan 100 mg Sumatriptan 100 mg -
- Primary Outcome Measures
Name Time Method Headache response at 1 hour after treatment of the first attack. 1 hour Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.
- Secondary Outcome Measures
Name Time Method Headache severity .5, 1, 2, 4 and 24 hours Pain-free response .5, 1, 2, 4 and 24 hours Functional response .5, 1, 2, 4 and 24 hours Presence or absence of nausea, photophobia, and phonophobia .5, 1, 2, 4 and 24 hours