Journal article
Trajectory of treatment response in the child and adolescent migraine prevention (CHAMP) study: A randomized clinical trial
Cephalalgia, Vol.42(1), pp.33310242110335-52
08/17/2021
DOI: 10.1177/03331024211033551
PMID: 34404270
Abstract
Objective Identify preventive medication treatment response trajectories among youth participating in the Childhood and Adolescent Migraine Prevention study. Methods Data were evaluated from 328 youth (ages 8–17). Childhood and Adolescent Migraine Prevention study participants completed headache diaries during a 28-day baseline period and a 168-day active treatment period during which youth took amitriptyline, topiramate, or placebo. Daily headache occurrence trajectories were established across baseline and active treatment periods using longitudinal hierarchical linear modeling. We tested potential treatment group differences. We also compared final models to trajectory findings from a clinical trial of cognitive behavioral therapy plus amitriptyline for youth with chronic migraine to test for reproducibility. Results Daily headache occurrence showed stability across baseline. Active treatment models revealed decreases in headache frequency that were most notable early in the trial period. Baseline and active treatment models did not differ by treatment group and replicated trajectory cognitive behavioral therapy plus amitriptyline trial findings. Conclusions Replicating headache frequency trajectories across clinical trials provides strong evidence that youth can improve quickly. Given no effect for medication, we need to better understand what drives this clinically meaningful improvement. Results also suggest an expected trajectory of treatment response for use in designing and determining endpoints for future clinical trials. Trial Registration. ClinicalTrials.gov Identifier: NCT01581281
Details
- Title: Subtitle
- Trajectory of treatment response in the child and adolescent migraine prevention (CHAMP) study: A randomized clinical trial
- Creators
- Brooke L Reidy - Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USAJames Peugh - Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USAAndrew D Hershey - Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA, Cincinnati Children’s Headache Center, Cincinnati, OH, USA, Division of Neurology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USAChristopher S Coffey - Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa College of Public Health, Iowa City, IA, USALeigh A Chamberlin - Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USADixie J Ecklund - Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa College of Public Health, Iowa City, IA, USAElizabeth A Klingner - Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa College of Public Health, Iowa City, IA, USAJon W Yankey - Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa College of Public Health, Iowa City, IA, USALeslie L Korbee - Academic Regulatory & Monitoring Services, LLC, Cincinnati, OH, USALinda L Porter - National Institute of Neurological Disorders and Stroke, Bethesda MD, USAMarielle A Kabbouche - Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA, Cincinnati Children’s Headache Center, Cincinnati, OH, USA, Division of Neurology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USAJoanne Kacperski - Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA, Cincinnati Children’s Headache Center, Cincinnati, OH, USA, Division of Neurology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USAScott W Powers - Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA, Cincinnati Children’s Headache Center, Cincinnati, OH, USA
- Resource Type
- Journal article
- Publication Details
- Cephalalgia, Vol.42(1), pp.33310242110335-52
- DOI
- 10.1177/03331024211033551
- PMID
- 34404270
- ISSN
- 0333-1024
- eISSN
- 1468-2982
- Grant note
- DOI: 10.13039/100000002, name: National Institutes of Health, award: T32DK063929, U01NS076788, U01NS077108
- Language
- English
- Date published
- 08/17/2021
- Academic Unit
- Biostatistics
- Record Identifier
- 9984214666702771
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