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

Prior treatment

• 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 is currently using an investigational drug or device or has used such within 30 days prior to Visit 1.

Other illness

• 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.

Other

• Subject has continuous migraines, defined as an unrelenting headache for a 28-day period.
• 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.

• Subject is a female or male 6 to 11 years of age, inclusive, at Visit 1 (Screening)
• 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
• 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 \[ICHD 3\]).
• Subject had ≥8 self-reported headache days in the 28 days prior to Screening.
• 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.