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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2003-12-31

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)

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Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

eletriptan

Intervention Type DRUG

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

Interventions

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eletriptan

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

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No