Chronic Migraine
Conditions
Interventions
Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks.
Sponsors
Otani Tetsuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1. During the last 28 days of the screening/baseline period, and as per eDiary: - Participant must have completed the eDiary for a minimum of 20 out of 28 days. - Participant has >= 15 headache days. - Participant has >= 8 migraine days.
Exclusion criteria
Exclusion criteria: Clinically significant hypertension per investigator's judgment. History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Adverse Events (AEs) [Time Frame: Up to approximately 16 weeks] - An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. Change From Baseline in Mean Monthly Migraine Days [Time Frame: Baseline (Week 0) through Week 12] - A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Mean Monthly Headache Days [Time Frame: Baseline (Week 0) through Week 12] - A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication (e.g., ibuprofen, triptan) was used after the start of the headache, in which case no minimum duration will be specified. Calendar days begin at midnight and last until 11:59 PM. Change From Baseline in Mean Monthly Acute Medication Use Days [Time Frame: Baseline (Week 0) through Week 12] - An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine. Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days [Time Frame: - Baseline (Week 0) through Week 12] A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM. Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score [Time Frame: Baseline (Week 0) through Week 12] - The PedsQL is a 23-item measure that evaluates quality of life in four areas of functioning: physical, emotional, social, and school functioning. The PedsQL yields a total quality of life score and two summary scores: Physical Health Summary Score and Psychosocial Health Summary Score. Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score [Time Frame: Baseline (Week 0) through Week 12] - The PedMIDAS scale evaluates the impact of headache on school performance, disability at home and social/sport function. The score is a composite of the total of 6 questions. | — |
Countries
Canada, Denmark, Hungary, Italy, Japan, Netherlands, Poland, Puerto Rico, United Kingdom, United States
Contacts
Public ContactContact for Patients and HCP
Abbvie G.K.
Outcome results
None listed