NCT00632385

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_4

Geographic Reach
1 country

16 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

January 1, 2003

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

First QC Date

March 3, 2008

Last Update Submit

January 26, 2021

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in headache pain severity

    1, 2, 4, and 24 hours

Secondary Outcomes (11)

  • Functional impairment

    1, 2, 4, and 24 hours

  • Work Productivity Questionnaire

    Week 10

  • Time Loss

    Week 10

  • Subject Preference Questionnaire

    Week 10

  • Global Evaluation

    Week 10

  • +6 more secondary outcomes

Study Arms (1)

A

EXPERIMENTAL
Drug: Eletriptan

Interventions

EletriptanDRUG

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

A

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Pfizer Investigational Site

Irvine, California, 92618, United States

Location

Pfizer Investigational Site

Newport Beach, California, 92660-2452, United States

Location

Pfizer Investigational Site

San Francisco, California, 94109, United States

Location

Pfizer Investigational Site

Plantation, Florida, 33324, United States

Location

Pfizer Investigational Site

St. Petersburg, Florida, 33710, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33609, United States

Location

Pfizer Investigational Site

Marietta, Georgia, 30067, United States

Location

Pfizer Investigational Site

South Bend, Indiana, 46601, United States

Location

Pfizer Investigational Site

Milford, Massachusetts, 01757, United States

Location

Pfizer Investigational Site

Chesterfield, Missouri, 63017, United States

Location

Pfizer Investigational Site

Springfield, Missouri, 65804, United States

Location

Pfizer Investigational Site

Greensboro, North Carolina, 27403, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45219, United States

Location

Pfizer Investigational Site

Eugene, Oregon, 97401, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Alexandria, Virginia, 22304, United States

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 3, 2008

First Posted

March 10, 2008

Study Start

January 1, 2003

Study Completion

August 1, 2003

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

US(16)