Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy
- Registration Number
- NCT00632385
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Eletriptan -
- Primary Outcome Measures
Name Time Method Change from baseline in headache pain severity 1, 2, 4, and 24 hours
- Secondary Outcome Measures
Name Time Method Functional impairment 1, 2, 4, and 24 hours Global Evaluation Week 10 Subject Preference Questionnaire Week 10 Subject Satisfaction Scale Week 10 Associated Symptoms 1, 2, 4, and 24 hours Work Productivity Questionnaire Week 10 Use of Rescue Medication Week 10 Time Loss Week 10 Vital signs Week 10 Adverse events Week 10 Physical examination Week 10
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Alexandria, Virginia, United States