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

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92618
        • Pfizer Investigational Site
      • Newport Beach, California, United States, 92660-2452
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94109
        • Pfizer Investigational Site
    • Florida
      • Plantation, Florida, United States, 33324
        • Pfizer Investigational Site
      • Saint Petersburg, Florida, United States, 33710
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33609
        • Pfizer Investigational Site
    • Georgia
      • Marietta, Georgia, United States, 30067
        • Pfizer Investigational Site
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Pfizer Investigational Site
    • Massachusetts
      • Milford, Massachusetts, United States, 01757
        • Pfizer Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Pfizer Investigational Site
      • Springfield, Missouri, United States, 65804
        • Pfizer Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in headache pain severity
Time Frame: 1, 2, 4, and 24 hours
1, 2, 4, and 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional impairment
Time Frame: 1, 2, 4, and 24 hours
1, 2, 4, and 24 hours
Work Productivity Questionnaire
Time Frame: Week 10
Week 10
Time Loss
Time Frame: Week 10
Week 10
Subject Preference Questionnaire
Time Frame: Week 10
Week 10
Global Evaluation
Time Frame: Week 10
Week 10
Subject Satisfaction Scale
Time Frame: Week 10
Week 10
Associated Symptoms
Time Frame: 1, 2, 4, and 24 hours
1, 2, 4, and 24 hours
Use of Rescue Medication
Time Frame: Week 10
Week 10
Adverse events
Time Frame: Week 10
Week 10
Vital signs
Time Frame: Week 10
Week 10
Physical examination
Time Frame: Week 10
Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (ACTUAL)

August 1, 2003

Study Registration Dates

First Submitted

March 3, 2008

First Submitted That Met QC Criteria

March 3, 2008

First Posted (ESTIMATE)

March 10, 2008

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1601092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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