Journal article
The Childhood and Adolescent Migraine Prevention (CHAMP) Study: A Report on Baseline Characteristics of Participants
Headache, Vol.56(5), pp.859-870
05/2016
DOI: 10.1111/head.12810
PMID: 27039826
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.
Details
- Title: Subtitle
- The Childhood and Adolescent Migraine Prevention (CHAMP) Study: A Report on Baseline Characteristics of Participants
- Creators
- Scott W Powers - Cincinnati Children's Hospital Medical CenterAndrew D Hershey - Cincinnati Children's Hospital Medical CenterChristopher S Coffey - Clinical Trials Statistical and Data Management Center, University of IowaLeigh A Chamberlin - Cincinnati Children's Hospital Medical CenterDixie J.D Ecklund - Clinical Trials Statistical and Data Management Center, University of IowaStephanie M Sullivan - Cincinnati Children's Hospital Medical CenterElizabeth A Klingner - Clinical Trials Statistical and Data Management Center, University of IowaJon W Yankey - Clinical Trials Statistical and Data Management Center, University of IowaSusmita Kashikar‐Zuck - Cincinnati Children's Hospital Medical CenterLeslie L Korbee - Office for Clinical and Translational Research, Cincinnati Children's Hospital Medical CenterMichele L Costigan - Clinical Trials Statistical and Data Management Center, University of IowaHolly H Riss - Clinical Trials Statistical and Data Management Center, University of IowaLinda L Porter - National Institute of Neurological Disorders and Stroke
- Resource Type
- Journal article
- Publication Details
- Headache, Vol.56(5), pp.859-870
- DOI
- 10.1111/head.12810
- PMID
- 27039826
- NLM abbreviation
- Headache
- ISSN
- 0017-8748
- eISSN
- 1526-4610
- Number of pages
- 12
- Language
- English
- Date published
- 05/2016
- Academic Unit
- Biostatistics
- Record Identifier
- 9983997997302771
Metrics
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