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

Phase 4

Completed

• Conditions: Migraine
• Interventions: Drug: eletriptan

• Registration Number: NCT00634985
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2002-11
• Study Completion: 2003-12
• Study First Submitted: 2008-03-03
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-13
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	eletriptan	-

Primary Outcome Measures

Name	Time	Method
Functional response post-treatment	2 hours
Headache severity and response post-treatment	2 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site