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Completed

NCT Number: NCT01986088

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

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.

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Key information

Conditions

Migraine With or Without Aura

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

matching placebo

Eletriptan 40 mg

Drug

40mg oral

Eletriptan 80 mg

Drug

80mg oral

Sumatriptan 50 mg

Drug

50mg oral

Sumatriptan 100 mg

Drug

100mg oral

Primary outcomes

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

    Time frame: 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 outcomes

  1. Headache severity

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

  2. Pain-free response

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

  3. Functional response

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

  4. Presence or absence of nausea, photophobia, and phonophobia

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

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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).

Important dates

Study start
1996
Primary completion
1998
Study completion
1998
First posted
Nov 18, 2013
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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