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

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

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

Intervention(s) in this Clinical Trial

• Drug: Eletriptan
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A

Primary Measures

• Change from baseline in headache pain severity
  • Time Frame: 1, 2, 4, and 24 hours
    Safety Issue?: No

Secondary Measures

• Functional impairment
  • Time Frame: 1, 2, 4, and 24 hours
    Safety Issue?: No
• Work Productivity Questionnaire
  • Time Frame: Week 10
    Safety Issue?: No
• Time Loss
  • Time Frame: Week 10
    Safety Issue?: No
• Subject Preference Questionnaire
  • Time Frame: Week 10
    Safety Issue?: No
• Global Evaluation
  • Time Frame: Week 10
    Safety Issue?: No
• Subject Satisfaction Scale
  • Time Frame: Week 10
    Safety Issue?: No
• Associated Symptoms
  • Time Frame: 1, 2, 4, and 24 hours
    Safety Issue?: No
• Use of Rescue Medication
  • Time Frame: Week 10
    Safety Issue?: No
• Adverse events
  • Time Frame: Week 10
    Safety Issue?: Yes
• Vital signs
  • Time Frame: Week 10
    Safety Issue?: Yes
• Physical examination
  • Time Frame: Week 10
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00632385

Study ID Number: A1601092

ClinicalTrials.gov Identifier: NCT00632385

Health Authority: United States: Food and Drug Administration

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