Childhood and Adolescent Migraine Prevention (CHAMP) Study: A Double-Blinded, Placebo-Controlled, Comparative Effectiveness Study of Amitriptyline, Topiramate, and Placebo in the Prevention of Childhood and Adolescent Migraine

Authors

  • Andrew D. Hershey MD, PhD, FAHS,

    1. Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA
    2. Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
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    • These authors contributed equally to this work.
  • Scott W. Powers PhD, FAHS,

    1. Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA
    2. Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
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    • These authors contributed equally to this work.
  • Christopher S. Coffey PhD,

    1. Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA, USA
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    • These authors contributed equally to this work.
  • Dixie D. Eklund RN, MSN, MBA,

    1. Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA, USA
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  • Leigh Ann Chamberlin RD, Med,

    1. Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
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  • Leslie L. Korbee BS,

    1. Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
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  • and on behalf of the CHAMP Study Group

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    • The members of the Childhood and Adolescent Migraine Prevention (CHAMP) Study Group: Executive Committee and Steering Group: Andrew D. Hershey, MD, PhD; Scott W. Powers, PhD; Christopher S. Coffey, PhD; D.D. Ecklund, RN, MSN, MBA; L.A. Chamberlin, RD, MEd; L.L. Korbee, BS. Clinical Coordinating Center, Cincinnati Children's Hospital Medical Center: J.R. Allen, MS; B.S. Aylward, PhD; A. Bizzarri, BS; J. Bush, RN, BSN, CPN; L.L. Chamberlin, RD, MEd; J. Hembree, AOS; Andrew D. Hershey, MD, PhD; S. Hope; M. Hoffman, RPh; M.A. Kabbouche, MD; J. Kacperski, MD; S. Kashikar-Zuck, PhD; L.L. Korbee, BS; D. Kraus, MSW; J.W. Kroner, BA; D. LaGory, RPh; S.L. LeCates, MSN, CNP; S.C. McMahan, RN; P. Manning, RN, BSN; T.K. Knilans, MD; H.L. O'Brien, MD; J. Peugh, PhD; Scott W. Powers, PhD; J. Rausch, PhD; M. Schuller, MA; C. Scott, BS, MBA; A. Segers, RN, BSN; K. Simmons, BS; P. Steele, MD; S.M. Sullivan, BS; P. Vaughn, MS, CNP; S. White, DNP, CNP. Data Coordinating Center, Clinical Trials Statistical and Data Management Center at the University of Iowa: W.R. Clark, PhD; C.S. Coffey, PhD; M. Costigan, RN, BSN; D.D. Ecklund, RN, MSN, MBA; T. Huff, BS; N. Logsden-Sackett, MS; R. Peters, BS; H. Riss, BA; J. Yankey, MS. National Institute of Neurological Disease and Stroke, Bethesda, MD: D.G Hirtz, MD; L. L. Porter, PhD; P. Gilbert, ScM.Clinical Research Consortium: Anne S. Lindblad, PhD, EMMES Corporation, Rockville, MD.

  • Conflict of Interest: The authors declare no conflict of interest.

Address all correspondence to A.D. Hershey, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, MLC 2015, Cincinnati, OH 45229-3039, USA.

Abstract

Background

Migraine is one of the most common health problems for children and adolescents. If not successfully treated, it can impact patients and families with significant disability due to loss of school, work, and social function. When headaches become frequent, it is essential to try to prevent the headaches. For children and adolescents, this is guided by extrapolation from adult studies, a limited number of small studies in children and adolescents and practitioner preference. The aim of the Childhood and Adolescent Migraine Prevention (CHAMP) study is to determine the most effective preventive agent to use in children and adolescents.

Methods

CHAMP is a double-blinded, placebo-controlled, multicenter, comparative effectiveness study of amitriptyline and topiramate for the prevention of episodic and chronic migraine, designed to mirror real-world practice, sponsored by the US National Institute of Neurological Disorders and Stroke/National Institutes of Health (U01NS076788). The study will recruit 675 subjects between the ages of 8 and 17 years old, inclusive, who have migraine with or without aura or chronic migraine as defined by the International Classification of Headache Disorders, 2nd Edition, with at least 4 headaches in the 28 days prior to randomization. The subjects will be randomized in a 2:2:1 (amitriptyline: topiramate: placebo) ratio. Doses are weight based and will be slowly titrated over an 8-week period to a target dose of 1 mg/kg of amitriptyline and 2 mg/kg of topiramate. The primary outcome will be a 50% reduction in headache frequency between the 28-day baseline and the final 28 days of treatment (weeks 20-24).

Conclusions

The goal of the CHAMP study is to obtain level 1 evidence for the effectiveness of amitriptyline and topiramate in the prevention of migraine in children and adolescents. If this study proves to be positive, it will provide information to the practicing physician as how to best prevent migraine in children and adolescents and subsequently improve the disability and outcomes.

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