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OpenTrials
Completed

NCT Number: NCT01986270

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

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.

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Key information

Conditions

Migraine With or Without Aura

Age range

18 year–65 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

  • 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.

Treatment and study plan

Placebo

Drug

Matching Placebo

Eletriptan 40 mg

Drug

40mg oral

Eletriptan 80 mg

Drug

80mg oral

Sumatriptan 25 mg

Drug

25mg oral

Sumatriptan 50 mg

Drug

50mg oral

Primary outcomes

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

    Time frame: 1 hour

    A pain free response was defined as an improvement from a severe or moderate headache at baseline to an absent headache 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, Placebo Controlled, Parallel Group, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels of of Oral Sumatriptan Given for the Acute Treatment of Migraine

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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