migraine headaches with or without aura
Conditions
Brief summary
Mean change from the Observation Phase in the number of migraine days per month over the entire double-blind treatment (DBT) Phase.
Detailed description
Proportion of subjects with ≥ 50% reduction from the Observation Phase in the number of migraine days of moderate or severe headache pain intensity per month over the entire DBT Phase (Weeks 1 to 12)., Mean change from the Observation Phase in the number of migraine days per month in the first 4 weeks (Weeks 1 to 4) of the DBT Phase., Mean change from the Observation Phase in the number of migraine days per month in the last 4 weeks (Weeks 9 to 12) of the DBT Phase., Mean change from baseline in the MSQ restrictive role function domain score at Week 12 of the DBT Phase., Mean change from baseline in the MIBS score at Week 12 of the DBT Phase.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from the Observation Phase in the number of migraine days per month over the entire double-blind treatment (DBT) Phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with ≥ 50% reduction from the Observation Phase in the number of migraine days of moderate or severe headache pain intensity per month over the entire DBT Phase (Weeks 1 to 12)., Mean change from the Observation Phase in the number of migraine days per month in the first 4 weeks (Weeks 1 to 4) of the DBT Phase., Mean change from the Observation Phase in the number of migraine days per month in the last 4 weeks (Weeks 9 to 12) of the DBT Phase., Mean change from baseline in the MSQ restrictive role function domain score at Week 12 of the DBT Phase., Mean change from baseline in the MIBS score at Week 12 of the DBT Phase. | — |
Countries
Austria, Belgium, Denmark, Finland, Germany, Italy, Poland, Spain, Sweden