migraine severe headache
Conditions
Interventions
335 subjects will be randomized in a 4:3:3 to the following treatment groups:
placebo for AMG 301, AMG 301 210 mg via SC injections Q4W, or AMG 301 420 mg
via SC injections Q2W, respectively
Sponsors
Amgen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults >= 18 to = 12 months before screening and who experience >= 4 migraine days per month. For a full list of eligibility criteria, please refer to the protocol
Exclusion criteria
Exclusion criteria: Adults >= 18 to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary End Point •Change from the baseline period in mean monthly migraine days. The mean monthly migraine days will be calculated using the migraine days over the last 4 weeks of the 12 week double blind treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary End Point •At least a 50% reduction from the baseline period in mean monthly migraine days in the last 4 weeks of the 12-week double-blind treatment period •Change from the baseline period in monthly acute migraine specific medication days in the last 4 weeks of the 12-week double-blind treatment period. •Change from the baseline period in mean physical impairment domain scores as measured by the MPFID over the last 4 weeks of the 12-week double-blind treatment period •Change from the baseline period in mean impact on everyday activities domain scores as measured by the MPFID over the last 4 weeks of the 12-week double blind treatment period Safety •Adverse events •Clinical laboratory values and vital signs | — |
Countries
Netherlands
Outcome results
None listed