Clinical trial NCT00634985: Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Headache severity and response post-treatment
timeFrame: 2 hours
measure: Functional response post-treatment
timeFrame: 2 hours
Secondary outcomes:
measure: Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment
timeFrame: 1, 2, 4, and 24 hours
measure: Migraine recurrence post-treatment
timeFrame: 1, 2, 4, and 24 hours
measure: Time loss (from normal activities and from work) post-treatment
timeFrame: 24 hours
measure: Subject preference and acceptability post-treatment
timeFrame: 24 hours and 12 weeks
measure: Subject satisfaction post-treatment
timeFrame: 2 and 24 hours
measure: Adverse events
timeFrame: Week 12
measure: Physical examination
timeFrame: Week 12
measure: Vital signs
timeFrame: Week 12
measure: Electrocardiogram
timeFrame: Week 12
measure: Headache severity and response at baseline and post-treatment
timeFrame: 1, 4 and 24 hours
measure: Functional impairment severity and response at baseline and post-treatment
timeFrame: 1, 4 and 24 hours
Other outcomes:
Locations:
city: Capa
country: Turkey
facility: Pfizer Investigational Site
state: Istanbul
city: Gaziantep
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Samsun
country: Turkey
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: