Migraine
Conditions
Brief summary
Change from baseline in Monthly Migraine Diary (Weeks 1-12) (efficacy)
Detailed description
Change from baseline in Monthly Migraine Diary (Weeks 1-12) (dose response), 50% Monthly Migraine Diary response: ≥50% reduction from baseline in Monthly Migraine Diaries (Weeks 1-12), 75% Monthly Migraine Diary response: ≥75% reduction from baseline in Monthly Migraine Diaries (Weeks 1-12), Change from baseline in Monthly Headache Days (Weeks 1-12), TEAEs, Changes from baseline in clinical safety laboratory test values, vital signs, weight, and ECG parameter values, PCS clinical safety laboratory test values, vital signs, weight changes, and ECG parameter values, Suicidal ideation and behaviour based on the C-SSRS, Development of ADAs, characterization of ADAs, and impact of ADA on PK, efficacy, and safety
Interventions
DRUGPlacebo to match IMP Lu AG09222
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Monthly Migraine Diary (Weeks 1-12) (efficacy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Monthly Migraine Diary (Weeks 1-12) (dose response), 50% Monthly Migraine Diary response: ≥50% reduction from baseline in Monthly Migraine Diaries (Weeks 1-12), 75% Monthly Migraine Diary response: ≥75% reduction from baseline in Monthly Migraine Diaries (Weeks 1-12), Change from baseline in Monthly Headache Days (Weeks 1-12), TEAEs, Changes from baseline in clinical safety laboratory test values, vital signs, weight, and ECG parameter values, PCS clinical safety laboratory test values, vital signs, weight changes, and ECG parameter values, Suicidal ideation and behaviour based on the C-SSRS, Development of ADAs, characterization of ADAs, and impact of ADA on PK, efficacy, and safety | — |
Countries
Bulgaria, Czechia, Denmark, France, Germany, Hungary, Lithuania, Poland, Romania, Slovakia, Spain
Outcome results
None listed