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

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ClinicalTrials.gov Identifier: NCT00632385
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : April 26, 2011
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Migraine Drug: Eletriptan Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy
Study Start Date : January 2003
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: Eletriptan
40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred >2 hours from first dose and within 24 hours of first dose


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in headache pain severity [ Time Frame: 1, 2, 4, and 24 hours ]

Secondary Outcome Measures :
  1. Functional impairment [ Time Frame: 1, 2, 4, and 24 hours ]
  2. Work Productivity Questionnaire [ Time Frame: Week 10 ]
  3. Time Loss [ Time Frame: Week 10 ]
  4. Subject Preference Questionnaire [ Time Frame: Week 10 ]
  5. Global Evaluation [ Time Frame: Week 10 ]
  6. Subject Satisfaction Scale [ Time Frame: Week 10 ]
  7. Associated Symptoms [ Time Frame: 1, 2, 4, and 24 hours ]
  8. Use of Rescue Medication [ Time Frame: Week 10 ]
  9. Adverse events [ Time Frame: Week 10 ]
  10. Vital signs [ Time Frame: Week 10 ]
  11. Physical examination [ Time Frame: Week 10 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632385


Locations
United States, California
Pfizer Investigational Site
Irvine, California, United States, 92618
Pfizer Investigational Site
Newport Beach, California, United States, 92660-2452
Pfizer Investigational Site
San Francisco, California, United States, 94109
United States, Florida
Pfizer Investigational Site
Plantation, Florida, United States, 33324
Pfizer Investigational Site
St Petersburg, Florida, United States, 33710
Pfizer Investigational Site
Tampa, Florida, United States, 33609
United States, Georgia
Pfizer Investigational Site
Marietta, Georgia, United States, 30067
United States, Indiana
Pfizer Investigational Site
South Bend, Indiana, United States, 46601
United States, Massachusetts
Pfizer Investigational Site
Milford, Massachusetts, United States, 01757
United States, Missouri
Pfizer Investigational Site
Chesterfield, Missouri, United States, 63017
Pfizer Investigational Site
Springfield, Missouri, United States, 65804
United States, North Carolina
Pfizer Investigational Site
Greensboro, North Carolina, United States, 27403
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Pfizer Investigational Site
Alexandria, Virginia, United States, 22304
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00632385     History of Changes
Other Study ID Numbers: A1601092
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rizatriptan
 Eletriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs