Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine

Phase 3CompletedNCT01978496

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1,334 enrolled

Overview

To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in relieving symptoms of acute migraine and to further explore the dose response relationship of eletriptan.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,334

Conditions

Migraine With or Without Aura

Interventions

PlaceboDRUG

matching placebo

Eletriptan 20 mgDRUG

20mg oral

Eletriptan 40 mgDRUG

40mg oral

Eletriptan 80 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

Inclusion Criteria: * History of at least one typical attack of migraine with or without aura every 6 weeks, as defined by the International Headache Society (IHS) criteria. * Capable of taking study medication as outpatients and recording its effects. Exclusion Criteria: * Pregnant or breast-feeding women * Migraine subjects who also suffered from concomitant frequent (non-migraine) headache, defined as more than six headaches per month on average * Migraine attacks that were thought to be atypical and had consistently failed to respond to medical therapy.

Outcomes

Primary Outcomes

Headache responder rate at two hours after the first dose for the first attack.

A headache response was defined as a subject having improvement in headache severity from grade 2 or 3 at baseline to 0 or 1 at two hours post-dose.

Time frame: 2 hours

Secondary Outcomes

Pain free responder rate at two hours after the first dose for the first attack.

Pain free response was defined as improvement from grade 2 or 3 at baseline to grade 0 at two hours post-dose.

Time frame: 2 hours

Data from ClinicalTrials.gov

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