A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine

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

A Multi-Center, Open-Label, Randomized, Parallel-Group Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine in Early Intervention.

To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

220

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

  • Canada
      • Mount Pearl, Canada
        • Pfizer Investigational Site
      • Quebec, Canada
        • Pfizer Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Pfizer Investigational Site
    • British Columbia
      • Chilliwack, British Columbia, Canada
        • Pfizer Investigational Site
      • Coquitlam, British Columbia, Canada
        • Pfizer Investigational Site
      • Langley, British Columbia, Canada
        • Pfizer Investigational Site
      • North Vancouver, British Columbia, Canada
        • Pfizer Investigational Site
      • Penticton, British Columbia, Canada
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Pfizer Investigational Site
    • New Brunswick
      • Bathurst, New Brunswick, Canada
        • Pfizer Investigational Site
      • Moncton, New Brunswick, Canada
        • Pfizer Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Pfizer Investigational Site
      • Truro, Nova Scotia, Canada
        • Pfizer Investigational Site
    • Ontario
      • Bolton, Ontario, Canada
        • Pfizer Investigational Site
      • Brampton, Ontario, Canada
        • Pfizer Investigational Site
      • Corunna, Ontario, Canada
        • Pfizer Investigational Site
      • Fort Erie, Ontario, Canada
        • Pfizer Investigational Site
      • Hamilton, Ontario, Canada
        • Pfizer Investigational Site
      • London, Ontario, Canada
        • Pfizer Investigational Site
      • Markham, Ontario, Canada
        • Pfizer Investigational Site
      • Mississauga, Ontario, Canada
        • Pfizer Investigational Site
      • Newmarket, Ontario, Canada
        • Pfizer Investigational Site
      • Niagara Falls, Ontario, Canada
        • Pfizer Investigational Site
      • Woodstock, Ontario, Canada
        • Pfizer Investigational Site
    • Prince Edward Island
      • Montague, Prince Edward Island, Canada
        • Pfizer Investigational Site
    • Quebec
      • Cowansville, Quebec, Canada
        • Pfizer Investigational Site
      • Drummondville, Quebec, Canada
        • Pfizer Investigational Site
      • Granby, Quebec, Canada
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada
        • Pfizer Investigational Site
      • Sainte Julie, Quebec, Canada
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Canada
        • Pfizer Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada
        • 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 with or without aura according to the recent IHS criteria.
  • Migraine headaches must have been present for more than one year.
  • History in the last 3 months of 1 to 4 acute attacks of migraine headache per month.

Exclusion Criteria:

  • Subjects with current or past history of coronary artery disease.
  • Pregnant or breastfeeding women.
  • Subjects who have chronic daily headaches.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate pain free response at 2 hours with eletriptan 40mg in mild pain compared to moderate to severe pain intensity of migraine in early intervention.

Secondary Outcome Measures

Outcome Measure
To demonstrate the efficacy of early intervention with eletriptan 40mg on mild compared to moderate to severe migraine pain include the following clinical outcomes: pain-free at 0.5, 1, 1.5, 4 and 24 hours; sustained pain-free, migraine recurrence

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

March 1, 2005

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

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

  • A1601107

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.

Clinical Trials on Migraine

Clinical Trials on eletriptan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe