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

Study Overview
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Brief Summary
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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
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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

Conditions
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Migraine

Intervention / Treatment
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* Drug: eletriptan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: eletriptan<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache severity and response post-treatment |  | 2 hours | 
| Functional response post-treatment |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment |  | 1, 2, 4, and 24 hours | 
| Migraine recurrence post-treatment |  | 1, 2, 4, and 24 hours | 
| Time loss (from normal activities and from work) post-treatment |  | 24 hours | 
| Subject preference and acceptability post-treatment |  | 24 hours and 12 weeks | 
| Subject satisfaction post-treatment |  | 2 and 24 hours | 
| Adverse events |  | Week 12 | 
| Physical examination |  | Week 12 | 
| Vital signs |  | Week 12 | 
| Electrocardiogram |  | Week 12 | 
| Headache severity and response at baseline and post-treatment |  | 1, 4 and 24 hours | 
| Functional impairment severity and response at baseline and post-treatment |  | 1, 4 and 24 hours |