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Champ Study

Champ Study Global Objective
To determine the optimal medication for the prevention of migraines in children and adolescents.

Champ Study Primary Objective
To test if amitriptyline (AMI) and topiramate (TPM) are superior to placebo in reducing migraine frequency* in children and adolescents, ages 8 to 17 years old, inclusive, and to conduct a comparative effectiveness study of the two therapies.

  • Specifically, we will determine if there is a 20 percentage point or greater difference in the proportion of subjects with a &ge 50% reduction in migraine frequency from the 4 week baseline period to the last 4 weeks of this 24-week trial between amitriptyline and placebo (Aim 1) and between topiramate and placebo (Aim 2). A 20 percentage point improvement from placebo is considered a minimum clinically meaningful difference by pediatric headache experts.
  • For the comparative effectiveness study, we will determine if there is a 15 percentage point or greater difference in the proportion of subjects with a &ge 50% reduction in migraine frequency from the 4 week baseline period to the last 4 weeks of this 24-week trial between amitriptyline and topiramate (Aim 3). This difference is considered clinically important by pediatric headache experts for comparison of two active interventions.