Skip to main content
OpenTrials
Completed

NCT Number: NCT00634985

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Çapa, Istanbul, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eletriptan

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

Primary outcomes

  1. Headache severity and response post-treatment

    Time frame: 2 hours

  2. Functional response post-treatment

    Time frame: 2 hours

Secondary outcomes

  1. Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment

    Time frame: 1, 2, 4, and 24 hours

  2. Migraine recurrence post-treatment

    Time frame: 1, 2, 4, and 24 hours

  3. Time loss (from normal activities and from work) post-treatment

    Time frame: 24 hours

  4. Subject preference and acceptability post-treatment

    Time frame: 24 hours and 12 weeks

  5. Subject satisfaction post-treatment

    Time frame: 2 and 24 hours

  6. Adverse events

    Time frame: Week 12

  7. Physical examination

    Time frame: Week 12

  8. Vital signs

    Time frame: Week 12

  9. Electrocardiogram

    Time frame: Week 12

  10. Headache severity and response at baseline and post-treatment

    Time frame: 1, 4 and 24 hours

  11. Functional impairment severity and response at baseline and post-treatment

    Time frame: 1, 4 and 24 hours

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2003
First posted
Mar 13, 2008
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.