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

Viatris

Status and phase: Completed; Phase 4

Conditions: Migraine

Treatments: Drug: eletriptan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00634985

A1601085

Details and patient eligibility

About

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)

Enrollment: 120 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

A

Experimental group

Treatment:

Drug: eletriptan