Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs

Condition(s) targeted: Migraine

Intervention: eletriptan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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)

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Headache severity and response post-treatment

Functional response post-treatment

Secondary outcome:

Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment

Migraine recurrence post-treatment

Time loss (from normal activities and from work) post-treatment

Subject preference and acceptability post-treatment

Subject satisfaction post-treatment

Adverse events

Physical examination

Vital signs

Electrocardiogram

Headache severity and response at baseline and post-treatment

Functional impairment severity and response at baseline and post-treatment

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Pfizer Investigational Site, Gaziantep, Turkey

Pfizer Investigational Site, Istanbul, Turkey

Pfizer Investigational Site, Izmir, Turkey

Pfizer Investigational Site, Samsun, Turkey

Pfizer Investigational Site, Unknown, Ankara, Turkey

Pfizer Investigational Site, Capa, Istanbul, Turkey

Pfizer Investigational Site, Unknown, Manisa, Turkey

To obtain contact information for a study center near you, click here.

Starting date: November 2002
Last updated: April 22, 2011