Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo

Phase 3CompletedNCT01986270

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1,141 enrolled

Overview

The objective of this study was to compare the efficacy, toleration and safety of eletriptan 40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with an acute migraine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,141

Conditions

Migraine With or Without Aura

Interventions

PlaceboDRUG

Matching Placebo

Eletriptan 40 mgDRUG

40mg oral

Eletriptan 80 mgDRUG

80mg oral

Sumatriptan 25 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who expected to suffer at least one acute attack of migraine, with or without aura, each 6 weeks (The diagnosis of migraine was to comply with the criteria proposed by the International Headache Society (IHS)) * Subjects capable of taking medication as outpatients, and recording the effects of such medication. Exclusion Criteria: * Pregnant or breast-feeding women * Migraine subjects who also suffered from concomitant frequent (non-migrainous) headache, defined as more than six attacks per month on average.

Outcomes

Primary Outcomes

Headache response at 1 hour after the first dose for 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

Pain-free response at 1 hour after the first dose for the first attack.

A pain free response was defined as an improvement from a severe or moderate headache at baseline to an absent headache post-dose.

Time frame: 1 hour

Data from ClinicalTrials.gov

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