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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00634985
Recruitment Status : Completed
First Posted : March 13, 2008
Last Update Posted : January 27, 2021
Sponsor:
Information provided by:
Pfizer

Study Description
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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)

Condition or disease Intervention/treatment Phase
Migraine Drug: eletriptan Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2002
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Eletriptan

Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: 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


Outcome Measures
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Primary Outcome Measures :
  1. Headache severity and response post-treatment [ Time Frame: 2 hours ]
  2. Functional response post-treatment [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634985


Locations
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Turkey
Pfizer Investigational Site
Capa, Istanbul, Turkey
Pfizer Investigational Site
Gaziantep, Turkey
Pfizer Investigational Site
Istanbul, Turkey
Pfizer Investigational Site
Izmir, Turkey
Pfizer Investigational Site
Samsun, Turkey
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00634985    
Other Study ID Numbers: A1601085
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Eletriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs