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OpenTrials
Completed

NCT Number: NCT01978496

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

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.

Completed

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Key information

Conditions

Migraine With or Without Aura

Age range

18 year–78 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

  • 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.

Treatment and study plan

Placebo

Drug

matching placebo

Eletriptan 20 mg

Drug

20mg oral

Eletriptan 40 mg

Drug

40mg oral

Eletriptan 80 mg

Drug

80mg oral

Primary outcomes

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

    Time frame: 2 hours

    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.

Secondary outcomes

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

    Time frame: 2 hours

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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Multicenter Double-blind, Randomized Placebo Controlled, Parallel Group, Study of the Efficacy and Safety of Oral Eletriptan in Subjects With Acute Migraine

Important dates

Study start
1996
Primary completion
1997
Study completion
1997
First posted
Nov 7, 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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