Migraine With or Without Aura
Conditions
Brief summary
To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in relieving symptoms of acute migraine and to further explore the dose response relationship of eletriptan.
Interventions
DRUGPlacebo
matching placebo
DRUGEletriptan 20 mg
20mg oral
DRUGEletriptan 40 mg
40mg oral
DRUGEletriptan 80 mg
80mg oral
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* History of at least one typical attack of migraine with or without aura every 6 weeks, as defined by the International Headache Society (IHS) criteria. * Capable of taking study medication as outpatients and recording its effects.
Exclusion criteria
* Pregnant or breast-feeding women * Migraine subjects who also suffered from concomitant frequent (non-migraine) headache, defined as more than six headaches per month on average * Migraine attacks that were thought to be atypical and had consistently failed to respond to medical therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache responder rate at two hours after the first dose for the first attack. | 2 hours | A headache response was defined as a subject having improvement in headache severity from grade 2 or 3 at baseline to 0 or 1 at two hours post-dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain free responder rate at two hours after the first dose for the first attack. | 2 hours | Pain free response was defined as improvement from grade 2 or 3 at baseline to grade 0 at two hours post-dose. |
Outcome results
None listed