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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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
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)
Headache severity and response post-treatment
Time frame: 2 hours
Functional response post-treatment
Time frame: 2 hours
Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment
Time frame: 1, 2, 4, and 24 hours
Migraine recurrence post-treatment
Time frame: 1, 2, 4, and 24 hours
Time loss (from normal activities and from work) post-treatment
Time frame: 24 hours
Subject preference and acceptability post-treatment
Time frame: 24 hours and 12 weeks
Subject satisfaction post-treatment
Time frame: 2 and 24 hours
Adverse events
Time frame: Week 12
Physical examination
Time frame: Week 12
Vital signs
Time frame: Week 12
Electrocardiogram
Time frame: Week 12
Headache severity and response at baseline and post-treatment
Time frame: 1, 4 and 24 hours
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Pfizer Investigational Site
Samsun, Turkey (Türkiye)
Pfizer Investigational Site
Functional impairment severity and response at baseline and post-treatment
Time frame: 1, 4 and 24 hours