Migraine
Conditions
Brief summary
To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy
Interventions
DRUGEletriptan
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
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in headache pain severity | 1, 2, 4, and 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Associated Symptoms | 1, 2, 4, and 24 hours |
| Use of Rescue Medication | Week 10 |
| Adverse events | Week 10 |
| Vital signs | Week 10 |
| Physical examination | Week 10 |
| Subject Satisfaction Scale | Week 10 |
| Work Productivity Questionnaire | Week 10 |
| Time Loss | Week 10 |
| Subject Preference Questionnaire | Week 10 |
| Global Evaluation | Week 10 |
| Functional impairment | 1, 2, 4, and 24 hours |
Countries
United States
Outcome results
None listed