Prevalence of Headache Days and Disability 3 Years After Participation in the Childhood and Adolescent Migraine Prevention Medication Trial

Scott W Powers; Christopher S Coffey; Leigh A Chamberlin; Dixie J Ecklund; Elizabeth A Klingner; Jon W Yankey; James L Peugh; Leslie L Korbee; Kerry Simmons; Stephanie M Sullivan; Marielle A Kabbouche; Joanne Kacperski; Linda L Porter; Brooke L Reidy; Andrew D Hershey

doi:10.1001/jamanetworkopen.2021.14712

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Prevalence of Headache Days and Disability 3 Years After Participation in the Childhood and Adolescent Migraine Prevention Medication Trial

Journal article

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Prevalence of Headache Days and Disability 3 Years After Participation in the Childhood and Adolescent Migraine Prevention Medication Trial

Scott W Powers, Christopher S Coffey, Leigh A Chamberlin, Dixie J Ecklund, Elizabeth A Klingner, Jon W Yankey, James L Peugh, Leslie L Korbee, Kerry Simmons, Stephanie M Sullivan, …

JAMA network open, Vol.4(7), pp.e2114712-e2114712

07/01/2021

DOI: 10.1001/jamanetworkopen.2021.14712

PMCID: PMC8276084

PMID: 34251445

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Abstract

Migraine is a common neurological disease that often begins in childhood and continues into adulthood; approximately 6 million children and adolescents in the United States cope with migraine, and many frequently experience significant disability and multiple headache days per week. Although pharmacological preventive treatments have been shown to offer some benefit to youth with migraine, additional research is needed to understand whether and how these benefits are sustained. To survey clinical status of youth with migraine who participated in the 24-week Childhood and Adolescent Migraine Prevention (CHAMP) trial over a 3-year follow-up period. This survey study used internet-based surveys collected from youth ages 8 to 17 years at 3, 6, 12, 18, 24, and 36 months after completion of the CHAMP trial, which randomized participants to amitriptyline, topiramate, or placebo. At the end of the trial, the study drug was stopped, and participants received clinical care of their choice thereafter. The CHAMP trial was conducted between May 2012 and November 2015, and survey follow-up was conducted June 2013 to June 2018. Participants in this survey study were representative of those randomized in the trial. Data were analyzed from March 2020 to April 2021. Survey completion. Headache days, disability (assessed using the Pediatric Migraine Disability Scale [PedMIDAS]), and self-report of ongoing use of prescription preventive medication. A total of 205 youth (mean [SD] age, 14.2 [2.3] years; 139 [68%] girls; mean [SD] history of migraine, 5.7 [3.1] years) participated in the survey. Retention of participants was 189 participants (92%) at month 6, 182 participants (88%) at month 12, 163 participants (80%) at month 18, 165 participants (80%) at month 24, and 155 participants (76%) at month 36. Over the course of the 3-year follow-up, participants consistently maintained meaningful reductions in headache days (mean [SD] headache days per 28 days: CHAMP baseline, 11.1 [6.0] days; CHAMP completion, 5.0 [5.7] days; 3-year follow-up, 6.1 [6.1] days) and disability (mean [SD] score: CHAMP baseline, 40.9 [26.4]; CHAMP completion, 17.9 [22.1]; 3-year follow-up, 12.3 [20.0]). At 3 years after completion of the CHAMP trial, headache days were approximately 1.5 per week (changed from about 3 per week at trial baseline) and disability had improved from the moderate range to the low mild range on the PedMIDAS. Longitudinal analyses showed that amitriptyline and topiramate did not explain intercept random effects for either mean rate of headache days per week (amitriptyline: estimate [SE], 0.07 [0.05]; P = .16; topiramate: estimate [SE], 0.04 [0.05]; P = .50) or headache disability PedMIDAS total score (amitriptyline: estimate [SE], 0.25 [0.38]; P = .52; topiramate: estimate [SE], -0.09 [0.39]; P = .82) changes over time. Of 153 participants who reported on prescription drug use at 3 years, only 1 participant (1%) reported using prevention medication, and most participants reported no medication use at most time points. These findings suggest that children and adolescents with longer than 5 years history of migraine who participated in the CHAMP trial may sustain positive clinical outcomes over time, even after discontinuing preventive pill-based treatment. This survey study could inform use and discontinuation timing of pharmacological preventive therapies for migraine in youth ages 8 to 17 years. Research is needed to examine mechanisms of treatment improvement and maintenance for preventive therapies, as well as placebo, in the pediatric population.

Adolescent

Child

Disabled Children - rehabilitation

Disabled Children - statistics & numerical data

Female

Headache - complications

Headache - epidemiology

Headache - prevention & control

Humans

Male

Prevalence

Self Report

Surveys and Questionnaires

Treatment Outcome

Details

Title: Subtitle: Prevalence of Headache Days and Disability 3 Years After Participation in the Childhood and Adolescent Migraine Prevention Medication Trial
Creators: Scott W Powers - Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio
Christopher S Coffey - Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa College of Public Health, Iowa City
Leigh A Chamberlin - Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
Dixie J Ecklund - Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa College of Public Health, Iowa City
Elizabeth A Klingner - Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa College of Public Health, Iowa City
Jon W Yankey - Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa College of Public Health, Iowa City
James L Peugh - Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
Leslie L Korbee - Academic Regulatory & Monitoring Services, Cincinnati, Ohio
Kerry Simmons - Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
Stephanie M Sullivan - Office for Clinical and Translational Research, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
Marielle A Kabbouche - Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
Joanne Kacperski - Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
Linda L Porter - National Institute of Neurological Disorders and Stroke, Bethesda, Maryland
Brooke L Reidy - Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio
Andrew D Hershey - Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
Resource Type: Journal article
Publication Details: JAMA network open, Vol.4(7), pp.e2114712-e2114712
DOI: 10.1001/jamanetworkopen.2021.14712
PMID: 34251445
PMCID: PMC8276084
NLM abbreviation: JAMA Netw Open
ISSN: 2574-3805
eISSN: 2574-3805
Language: English
Date published: 07/01/2021
Academic Unit: Biostatistics
Record Identifier: 9984214695002771

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