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Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy

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

Condition(s) targeted: Migraine

Intervention: Eletriptan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

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

Summary

To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy

Clinical Details

Official title: An Open-label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline in headache pain severity

Secondary outcome:

Functional impairment

Work Productivity Questionnaire

Time Loss

Subject Preference Questionnaire

Global Evaluation

Subject Satisfaction Scale

Associated Symptoms

Use of Rescue Medication

Adverse events

Vital signs

Physical examination

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of migraine headache according to International Headache Society criteria

and migraine headaches for at least 1 year

- Eletriptan naive

- Previously treated with rizatriptan and failed to achieve a satisfactory response

within the past 12 months Exclusion Criteria:

- Non-migraine headaches on average more than 6 days per month or have less than 24

hours of freedom from headache between migraine attacks

- Migraine attacks that are atypical or chronic daily headaches

- A history of migraine with prolonged aura, familial hemiplegic migraine, basilar

migraine, migrainous infarction, migraine aura without headache, migraine with acute onset aura

Locations and Contacts

Pfizer Investigational Site, Irvine, California 92618, United States

Pfizer Investigational Site, Newport Beach, California 92660-2452, United States

Pfizer Investigational Site, San Francisco, California 94109, United States

Pfizer Investigational Site, Plantation, Florida 33324, United States

Pfizer Investigational Site, St Petersburg, Florida 33710, United States

Pfizer Investigational Site, Tampa, Florida 33609, United States

Pfizer Investigational Site, Marietta, Georgia 30067, United States

Pfizer Investigational Site, South Bend, Indiana 46601, United States

Pfizer Investigational Site, Milford, Massachusetts 01757, United States

Pfizer Investigational Site, Chesterfield, Missouri 63017, United States

Pfizer Investigational Site, Springfield, Missouri 65804, United States

Pfizer Investigational Site, Greensboro, North Carolina 27403, United States

Pfizer Investigational Site, Cincinnati, Ohio 45219, United States

Pfizer Investigational Site, Eugene, Oregon 97401, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, Alexandria, Virginia 22304, United States

Additional Information

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

Starting date: January 2003
Last updated: April 22, 2011

Page last updated: August 23, 2015

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