CHAMP Trial: pediatric migraine topiramate vs amitriptyline vs placebo

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CHAMP
Powers, S. W. et al. Trial of Amitriptyline, Topiramate, and Placebo for Pediatric Migraine. N. Engl. J. Med. 376, 115–124 (2017).
Powers, S. W., Hershey, A. D., Coffey, C. S. & CHAMP Study Group. The childhood and adolescent migraine prevention (CHAMP) study: ‘what do we do now?’ Headache 57, 180–183 (2017).
Powers, S. W. et al. The Childhood and Adolescent Migraine Prevention (CHAMP) Study: A Report on Baseline Characteristics of Participants. Headache 56, 859–870 (2016).
Hershey, A. D. et al. 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. Headache 53, 799–816 (2013).
Powers, S. W. et al. Prevalence of Headache Days and Disability 3 Years After Participation in the Childhood and Adolescent Migraine Prevention Medication Trial. JAMA Netw Open 4, e2114712 (2021).

Change from baseline
https://hbiostat.org/blog/post/errmed/
Vickers, A. J. The use of percentage change from baseline as an outcome in a controlled trial is statistically inefficient: a simulation study. BMC Med. Res. Methodol. 1, 6 (2001).
Goldenholz, D. M., Moss, R., Scott, J., Auh, S. & Theodore, W. H. Confusing placebo effect with natural history in epilepsy: A big data approach. Ann. Neurol. 78, 329–336 (2015).
Romero, J., Larimer, P., Chang, B., Goldenholz, S. R. & Goldenholz, D. M. Natural variability in seizure frequency: Implications for trials and placebo. Epilepsy Res. 162, 106306 (2020).
Tu, Y.-K. & Gilthorpe, M. S. Revisiting the relation between change and initial value: a review and evaluation. Stat. Med. 26, 443–457 (2007).

Unequal randomization
Hey, S. P. & Kimmelman, J. The questionable use of unequal allocation in confirmatory trials. Neurology 82, 77–79 (2014).
Peckham, E. et al. The use of unequal randomisation in clinical trials--An update. Contemp. Clin. Trials 45, 113–122 (2015).

Other headache trials
Lewis, D. et al. Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of topiramate for migraine prevention in pediatric subjects 12 to 17 years of age. Pediatrics 123, 924–934 (2009).
Locher, C. et al. Efficacy, Safety, and Acceptability of Pharmacologic Treatments for Pediatric Migraine Prophylaxis: A Systematic Review and Network Meta-analysis. JAMA Pediatr. 174, 341–349 (2020).
Powers, S. W. et al. Cognitive behavioral therapy plus amitriptyline for chronic migraine in children and adolescents: a randomized clinical trial. JAMA 310, 2622–2630 (2013).
Lakshmi, C. V. S., Singhi, P., Malhi, P. & Ray, M. Topiramate in the prophylaxis of pediatric migraine: a double-blind placebo-controlled trial. J. Child Neurol. 22, 829–835 (2007).
Winner, P. et al. Topiramate for migraine prevention in children: a randomized, double-blind, placebo-controlled trial. Headache 45, 1304–1312 (2005).
Lewis, D. W., Winner, P. & Wasiewski, W. The placebo responder rate in children and adolescents. Headache 45, 232–239 (2005).

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