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 impairmentWork 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
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