Migraine
Conditions
Brief summary
The endpoints of Study M21-199 are the safety and tolerability of atogepant, including: Adverse event (AE) monitoring for severity and incidence including adverse event of special interests (AESIs), Clinical laboratory testing (hematology, chemistry, and urinalysis), Electrocardiogram (ECG) variables, Vital sign measurements, Treatment-emergent suicidal ideations with intent, with or without a plan (i.e., Type 4 or 5 on Columbia-Suicide Severity Rating Scale [C-SSRS]) or any suicidal behaviors, Menstrual cycle assessments (female subject only), Tanner Stage scale, Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF2)
Interventions
DRUGAtogepant
Sponsors
Abbvie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The endpoints of Study M21-199 are the safety and tolerability of atogepant, including: Adverse event (AE) monitoring for severity and incidence including adverse event of special interests (AESIs), Clinical laboratory testing (hematology, chemistry, and urinalysis), Electrocardiogram (ECG) variables, Vital sign measurements, Treatment-emergent suicidal ideations with intent, with or without a plan (i.e., Type 4 or 5 on Columbia-Suicide Severity Rating Scale [C-SSRS]) or any suicidal behaviors, Menstrual cycle assessments (female subject only), Tanner Stage scale, Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF2) | — |
Countries
Belgium, Denmark, France, Hungary, Italy, Netherlands, Poland, Romania, Spain, Sweden
Outcome results
None listed