Migraine With Aura, Migraine Without Aura
Conditions
Brief summary
Evaluation of headache response at 2 hours for active treated attacks for increasing dose.
Interventions
DRUGPlacebo
All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
DRUGEletriptan HBr 80 mg
All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
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 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and Female subjects in good general health, aged 18 to 65 years. * Subjects should meet IHS diagnostic criteria for migraine with or without aura. * Based on past history, subjects should expect to suffer at least one acute attack of migraine with or without aura, each 6 weeks
Exclusion criteria
* Known coronary-artery disease, clinically significant arrhythmia, heart failure, or uncontrolled hypertension. * Pregnant or lactating women. * Clinically significant electrocardiogram abnormalities at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consistency of headache response (3 responses out of 3 active treated attacks) . Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose. | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Consistency of headache response (2 responses out of 3 active treated attacks). Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose. | 24 weeks |
Countries
Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Turkey (Türkiye)
Outcome results
None listed