title: The Childhood and Adolescent Migraine Prevention (CHAMP) Study: A Report on Baseline Characteristics of Participants.
abstract: OBJECTIVE
  To describe baseline headache characteristics of children and adolescents participating in a multicenter, randomized, double-blinded, placebo-controlled, comparative effectiveness study of amitriptyline, topiramate, and placebo for the prevention of migraine (CHAMP Study).
  
  
  METHODS
  Children and adolescents (age 8-17 years old, inclusive) diagnosed with migraine with or without aura, having headaches at least four times per month were enrolled from 2012 through 2014. The trial involved a baseline period (minimum of 28 days) during which prospective diaries were completed and demographics and headache features obtained.
  
  
  RESULTS
  A total of 488 children and adolescents (mean age 14.0 ± 2.4 years) agreed to participate in the trial, with 361 randomized and 127 not randomized. Randomized subjects had a 5.5 ± 3.1 year history of headaches, with 15.1 ± 7.1 headache days per month (based upon retrospective report at screening visit). Prospective diaries reported 11.5 ± 6.1 headache days per 28 day baseline. Across this 28 day period, reported headache days per week were stable (about 3 headache days per week). Recording of individual headache features by diary (n = 4136 headache days) showed characteristics consistent with migraine (mean duration 10.5 ± 8.1 hours, mean severity 6.0 ± 2.1, 60% throbbing, 55% with activity worsening headaches, 55% with photophobia, and 47% with phonophobia).
  
  
  CONCLUSIONS
  Baseline data from the CHAMP Study suggested that the randomized sample was representative of the real world population of children and adolescents that present for treatment of migraine. Headaches in children and adolescents recorded during a 28 day prospective baseline period in this multi-site comparative effectiveness study did not change over the course of the baseline period, even though a clear diagnosis, recommendation for effective acute treatment, and standardized education about healthy habits occurred prior to the diary collection period.
authors.affiliation: Department of Pediatrics, University of Cincinnati, College of Medicine, Cincinnati, OH, USA.|Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Scott W
authors.initials: SW
authors.lastname: Powers
authors.affiliation: Department of Pediatrics, University of Cincinnati, College of Medicine, Cincinnati, OH, USA.|Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Hershey
authors.affiliation: Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA, USA.
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Coffey
authors.affiliation: Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Leigh A
authors.initials: LA
authors.lastname: Chamberlin
authors.affiliation: Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA, USA.
authors.forename: Dixie J D
authors.initials: DJD
authors.lastname: Ecklund
authors.affiliation: Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Stephanie M
authors.initials: SM
authors.lastname: Sullivan
authors.affiliation: Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA, USA.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Klingner
authors.affiliation: Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA, USA.
authors.forename: Jon W
authors.initials: JW
authors.lastname: Yankey
authors.affiliation: Department of Pediatrics, University of Cincinnati, College of Medicine, Cincinnati, OH, USA.|Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Susmita
authors.initials: S
authors.lastname: Kashikar-Zuck
authors.affiliation: Office for Clinical and Translational Research, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Leslie L
authors.initials: LL
authors.lastname: Korbee
authors.affiliation: Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA, USA.
authors.forename: Michele L
authors.initials: ML
authors.lastname: Costigan
authors.affiliation: Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA, USA.
authors.forename: Holly H
authors.initials: HH
authors.lastname: Riss
authors.affiliation: National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.
authors.forename: Linda L
authors.initials: LL
authors.lastname: Porter
keywords: headache characterization; headache days; pediatrics; preventive medication; randomized clinical trial