A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years

Launched by ABBVIE · Jan 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called atogepant to see how well it can help prevent chronic migraines in teenagers aged 12 to 17. Chronic migraines are severe headaches that can happen often and may come with symptoms like nausea and sensitivity to light or sound. In this study, about 420 participants will take either atogepant or a placebo (a pill that looks like the medication but has no active ingredients) once a day for 12 weeks. The goal is to compare the effects of atogepant against the placebo to determine if it effectively reduces migraine occurrences.

To participate, teens need to have a history of chronic migraines for at least six months and experience a certain number of headache days each month. Those with significant health issues or certain other medical conditions may not be eligible. Throughout the study, participants will have regular check-ins at a clinic, where they will fill out daily diaries about their headaches, undergo medical assessments, and have blood tests to monitor their health and any side effects. This trial is important because it could help find new ways to help young people manage and prevent migraines more effectively.

Gender

ALL

Eligibility 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:
• • Clinically significant hypertension per investigator's judgment.
• • History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.