Migraine
Conditions
Brief summary
To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of migraine.
Interventions
DRUGeletriptan
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of migraine with or without aura according to the recent IHS criteria. * Migraine headaches must have been present for more than one year. * History in the last 3 months of 1 to 4 acute attacks of migraine headache per month.
Exclusion criteria
* Subjects with current or past history of coronary artery disease. * Pregnant or breastfeeding women. * Subjects who have chronic daily headaches.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate pain free response at 2 hours with eletriptan 40mg in mild pain compared to moderate to severe pain intensity of migraine in early intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate the efficacy of early intervention with eletriptan 40mg on mild compared to moderate to severe migraine pain include the following clinical outcomes: pain-free at 0.5, 1, 1.5, 4 and 24 hours; sustained pain-free, migraine recurrence | — |
Countries
Canada
Outcome results
None listed