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OpenTrials
Completed

NCT Number: NCT00632385

Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy

To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Irvine, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of migraine headache according to International Headache Society criteria and migraine headaches for at least 1 year
  • Eletriptan naive
  • Previously treated with rizatriptan and failed to achieve a satisfactory response within the past 12 months

Exclusion criteria

  • Non-migraine headaches on average more than 6 days per month or have less than 24 hours of freedom from headache between migraine attacks
  • Migraine attacks that are atypical or chronic daily headaches
  • A history of migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, migraine with acute onset aura

Treatment and study plan

eletriptan

Drug

40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred >2 hours from first dose and within 24 hours of first dose

Primary outcomes

  1. Change from baseline in headache pain severity

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

Secondary outcomes

  1. Functional impairment

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

  2. Work Productivity Questionnaire

    Time frame: Week 10

  3. Time Loss

    Time frame: Week 10

  4. Subject Preference Questionnaire

    Time frame: Week 10

  5. Global Evaluation

    Time frame: Week 10

  6. Subject Satisfaction Scale

    Time frame: Week 10

  7. Associated Symptoms

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

  8. Use of Rescue Medication

    Time frame: Week 10

  9. Adverse events

    Time frame: Week 10

  10. Vital signs

    Time frame: Week 10

  11. Physical examination

    Time frame: Week 10

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

An Open-label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy

Important dates

Study start
2003
Study completion
2003
First posted
Mar 10, 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.

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