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

Condition(s) targeted: Migraine With or Without Aura

Intervention: Placebo (Drug); Eletriptan 40 mg (Drug); Eletriptan 80 mg (Drug); Sumatriptan 50 mg (Drug); Sumatriptan 100 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: A Multicentre, Double Blind, Double Dummy, Parallel Group, Placebo Controlled, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels Oral Sumatriptan Given for the Acute Treatment of Migraine(With and Without Aura).

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

Headache severity

Pain-free response

Functional response

Presence or absence of nausea, photophobia, and phonophobia

Minimum age: 18 Years. Maximum age: 76 Years. Gender(s): Both.

Criteria:

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.

To obtain contact information for a study center near you, click here.

Starting date: November 1996
Last updated: November 11, 2013