Trajectory of treatment response in the child and adolescent migraine prevention (CHAMP) study: A randomized clinical trial.

Autor: Reidy BL; 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., Peugh J; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA., Hershey AD; 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, USA., Coffey CS; Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa College of Public Health, Iowa City, IA, USA., Chamberlin LA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA., Ecklund DJ; Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa College of Public Health, Iowa City, IA, USA., Klingner EA; Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa College of Public Health, Iowa City, IA, USA., Yankey JW; Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa College of Public Health, Iowa City, IA, USA., Korbee LL; Academic Regulatory & Monitoring Services, LLC, Cincinnati, OH, USA., Porter LL; National Institute of Neurological Disorders and Stroke, Bethesda MD, USA., Kabbouche MA; 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, USA., Kacperski J; 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, USA., Powers SW; 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.
Jazyk: angličtina
Zdroj: Cephalalgia : an international journal of headache [Cephalalgia] 2022 Jan; Vol. 42 (1), pp. 44-52. Date of Electronic Publication: 2021 Aug 17.
DOI: 10.1177/03331024211033551
Abstrakt: 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.
Databáze: MEDLINE
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