Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study

Phase 3CompletedNCT01986088

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1,008 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,008

Conditions

Migraine With or Without Aura

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 76 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Headache response at 1 hour after treatment of the first attack.

Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.

Time frame: 1 hour

Secondary Outcomes

Headache severity

Time frame: .5, 1, 2, 4 and 24 hours

Pain-free response

Time frame: .5, 1, 2, 4 and 24 hours

Functional response

Time frame: .5, 1, 2, 4 and 24 hours

Presence or absence of nausea, photophobia, and phonophobia

Time frame: .5, 1, 2, 4 and 24 hours