Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs
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
1 other identifier
interventional
120
1 country
5
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2002
Shorter than P25 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 3, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedJanuary 27, 2021
January 1, 2021
March 3, 2008
January 26, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Headache severity and response post-treatment
2 hours
Functional response post-treatment
2 hours
Secondary Outcomes (11)
Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment
1, 2, 4, and 24 hours
Migraine recurrence post-treatment
1, 2, 4, and 24 hours
Time loss (from normal activities and from work) post-treatment
24 hours
Subject preference and acceptability post-treatment
24 hours and 12 weeks
Subject satisfaction post-treatment
2 and 24 hours
- +6 more secondary outcomes
Study Arms (1)
A
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Pfizer Investigational Site
Çapa, Istanbul, Turkey (Türkiye)
Pfizer Investigational Site
Gaziantep, Turkey (Türkiye)
Pfizer Investigational Site
Istanbul, Turkey (Türkiye)
Pfizer Investigational Site
Izmir, Turkey (Türkiye)
Pfizer Investigational Site
Samsun, Turkey (Türkiye)
Pfizer Investigational Site
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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 13, 2008
Study Start
November 1, 2002
Study Completion
December 1, 2003
Last Updated
January 27, 2021
Record last verified: 2021-01