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

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Anti-Inflammatory Agents, Non-Steroidal; Eletriptan

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