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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00632385
First received: March 3, 2008
Last updated: April 22, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Migraine
Drug: Eletriptan
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in headache pain severity [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional impairment [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]
  • Work Productivity Questionnaire [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • Time Loss [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • Subject Preference Questionnaire [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • Global Evaluation [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • Subject Satisfaction Scale [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • Associated Symptoms [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]
  • Use of Rescue Medication [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Week 10 ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Week 10 ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: Week 10 ] [ Designated as safety issue: Yes ]

Enrollment: 127
Study Start Date: January 2003
Study Completion Date: August 2003
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00632385     History of Changes
Other Study ID Numbers: A1601092
Study First Received: March 3, 2008
Last Updated: April 22, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014