Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old

Exclusion Criteria12

• Subject has continuous migraines, defined as an unrelenting headache for a 28-day period.
• Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening).
• Subject is currently receiving migraine prevention medication and has initiated or changed the dose within 28 days of Screening or is unwilling to avoid making a change during the duration of the study.
• Subject has previously failed an adequate trial of topiramate (at least 3 months duration at a clinically appropriate dose) for prophylaxis of migraine headache due to lack of efficacy or AEs.
• Subject has previously failed an adequate trial of \>3 migraine preventative medications.
• Subject has a known history of allergic reaction to topiramate or any excipient in Qudexy XR.
• Subject has a diagnosis or history of disease that may interfere with safety or evaluation of the study drug.
• Subject is currently using an investigational drug or device or has used such within 30 days prior to Visit 1.
• Subject has begun menses and any of the following:
• Subject has tested positive for pregnancy; OR
• Subject is pregnant, planning pregnancy, or lactating; OR
• Subject is taking an oral hormonal contraceptive (either combined \[estrogen and progestogen containing\] or progestogen-only) and is unable or unwilling to switch to an alternative highly effective contraceptive method.