NCT00174395

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

First QC Date

September 9, 2005

Last Update Submit

January 26, 2021

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

eletriptanDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Pfizer Investigational Site

Edmonton, Alberta, Canada

Location

Pfizer Investigational Site

Chilliwack, British Columbia, Canada

Location

Pfizer Investigational Site

Coquitlam, British Columbia, Canada

Location

Pfizer Investigational Site

Langley, British Columbia, Canada

Location

Pfizer Investigational Site

North Vancouver, British Columbia, Canada

Location

Pfizer Investigational Site

Penticton, British Columbia, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, Canada

Location

Pfizer Investigational Site

Bathurst, New Brunswick, Canada

Location

Pfizer Investigational Site

Moncton, New Brunswick, Canada

Location

Pfizer Investigational Site

St. John's, Newfoundland and Labrador, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, Canada

Location

Pfizer Investigational Site

Truro, Nova Scotia, Canada

Location

Pfizer Investigational Site

Bolton, Ontario, Canada

Location

Pfizer Investigational Site

Brampton, Ontario, Canada

Location

Pfizer Investigational Site

Corunna, Ontario, Canada

Location

Pfizer Investigational Site

Fort Erie, Ontario, Canada

Location

Pfizer Investigational Site

Hamilton, Ontario, Canada

Location

Pfizer Investigational Site

London, Ontario, Canada

Location

Pfizer Investigational Site

Markham, Ontario, Canada

Location

Pfizer Investigational Site

Mississauga, Ontario, Canada

Location

Pfizer Investigational Site

Newmarket, Ontario, Canada

Location

Pfizer Investigational Site

Niagara Falls, Ontario, Canada

Location

Pfizer Investigational Site

Woodstock, Ontario, Canada

Location

Pfizer Investigational Site

Montague, Prince Edward Island, Canada

Location

Pfizer Investigational Site

Cowansville, Quebec, Canada

Location

Pfizer Investigational Site

Drummondville, Quebec, Canada

Location

Pfizer Investigational Site

Granby, Quebec, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, Canada

Location

Pfizer Investigational Site

Québec, Quebec, Canada

Location

Pfizer Investigational Site

Sainte-Julie, Quebec, Canada

Location

Pfizer Investigational Site

Sherbrooke, Quebec, Canada

Location

Pfizer Investigational Site

Regina, Saskatchewan, Canada

Location

Pfizer Investigational Site

Mount Pearl, Canada

Location

Related Links

MeSH Terms

Conditions

Migraine Disorders

Interventions

eletriptan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

March 1, 2005

Study Completion

October 1, 2006

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

CA(33)