Chronic Migraine
Conditions
Keywords
Migraine, Chronic Migraine, Atogepant, QULIPTA, AQUIPTA
Brief summary
Migraine is a disease that most often causes moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age. Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world. Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks. Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.
Interventions
DRUGAtogepant
Oral tablet
Oral tablet
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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
* 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 | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) | 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 | 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 | Description |
|---|---|---|
| Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score | 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. |
| Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days | 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 Mean Monthly Acute Medication Use Days | 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. |
| Change From Baseline in Mean Monthly Headache Days | 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 the Pediatric Quality of Life Inventory (PedsQL) Total Score | 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. |
Countries
Canada, Denmark, Hungary, Italy, Japan, Netherlands, Poland, Portugal, Puerto Rico, United Kingdom, United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed