Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
Trial Parameters
Brief Summary
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Eligibility Criteria
Inclusion Criteria: 1. Subject is a female or male 6 to 11 years of age, inclusive, at Visit 1 (Screening) 2. Subject weighs at least 17.0 kg and less than 50.0 kg at Visit 1 (Screening) based on 95 percentile weight for the age range.11 3. Subject has at least a 6-month history of headaches consistent with a diagnosis of migraine with or without aura (International Classification of Headache Disorders, 3rd Edition \[ICHD 3\]). 4. Subject had ≥8 self-reported headache days in the 28 days prior to Screening. 5. Subject has a PedMIDAS score \>10, indicating at least mild disruption in daily activities, and \<140, indicating extreme disability that may require more comprehensive, multi component therapy. Exclusion Criteria: 1. Subject has continuous migraines, defined as an unrelenting headache for a 28-day period. 2. Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening). 3. Subject is currently receiving migraine preven