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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine With or Without Aura

Intervention: Placebo (Drug); Eletriptan 20 mg (Drug); Eletriptan 40 mg (Drug); Eletriptan 80 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

Summary

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.

Clinical Details

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

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

Primary outcome: Headache responder rate at two hours after the first dose for the first attack.

Secondary outcome: Pain free responder rate at two hours after the first dose for the first attack.

Eligibility

Minimum age: 18 Years. Maximum age: 78 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

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

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

Page last updated: August 23, 2015

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