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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00634985

Enrollment

120

Registered

2008-03-13

Start date

2002-11-30

Completion date

2003-12-31

Last updated

2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

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)

Interventions

DRUGeletriptan

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
Headache severity and response post-treatment	2 hours
Functional response post-treatment	2 hours

Secondary

Measure	Time frame
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
Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment	1, 2, 4, and 24 hours
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
Physical examination	Week 12
Migraine recurrence post-treatment	1, 2, 4, and 24 hours

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026