Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs

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

A Multicentre, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Eletriptan 40 Mg for the Treatment of Migraine (With or Without Aura) in Subjects Unsuccessfully Treated With NSAIDS

To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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

        • Pfizer Investigational Site
  • Turkey
      • Gaziantep, Turkey
        • Pfizer Investigational Site
      • Istanbul, Turkey
        • Pfizer Investigational Site
      • Izmir, Turkey
        • Pfizer Investigational Site
      • Samsun, Turkey
        • Pfizer Investigational Site
    • Istanbul
      • Capa, Istanbul, Turkey
        • 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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Met International Headache Society diagnostic criteria for migraine with or without aura
  • Expected to suffer one to six acute migraine attacks per month based on past history
  • Experienced migraines for at least one year prior to entering study, and historically have not responded to NSAIDs

Exclusion Criteria:

  • Frequent migraine or frequent concomitant non-migrainous headache (average of >6 attacks per month)
  • Atypical migraines that consistently failed to respond to adequate medical therapy
  • Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, or 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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: eletriptan
40 mg oral tablet for migraine attack; additional 40 mg oral tablet >2 hours from first dose if migraine reoccurred within 24 hours of achieving response

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Headache severity and response post-treatment
Time Frame: 2 hours
2 hours
Functional response post-treatment
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Week 12
Week 12
Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment
Time Frame: 1, 2, 4, and 24 hours
1, 2, 4, and 24 hours
Migraine recurrence post-treatment
Time Frame: 1, 2, 4, and 24 hours
1, 2, 4, and 24 hours
Time loss (from normal activities and from work) post-treatment
Time Frame: 24 hours
24 hours
Subject preference and acceptability post-treatment
Time Frame: 24 hours and 12 weeks
24 hours and 12 weeks
Subject satisfaction post-treatment
Time Frame: 2 and 24 hours
2 and 24 hours
Physical examination
Time Frame: Week 12
Week 12
Vital signs
Time Frame: Week 12
Week 12
Electrocardiogram
Time Frame: Week 12
Week 12
Headache severity and response at baseline and post-treatment
Time Frame: 1, 4 and 24 hours
1, 4 and 24 hours
Functional impairment severity and response at baseline and post-treatment
Time Frame: 1, 4 and 24 hours
1, 4 and 24 hours

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

November 1, 2002

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

March 3, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 13, 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

  • A1601085

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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