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Setting: 31 sites in the USA.
Patients: Children and adolescents aged 8–17 years with a diagnosis of migraine plus Pediatric Migraine Disability Assessment Score (PedMIDAS) indicating mild to severe disability and four or more headaches over the initial 28 day baseline period.
Intervention: 1 mg/kg/day amitriptyline versus 2 mg/kg/day topiramate versus placebo. There was a 28-day period initially before medication started to monitor baseline migraine frequency, the active medication was started and dose slowly increased for 8 weeks with 16-week maintenance period, to complete 24 weeks in total.
Outcomes: Primary outcome was relative reduction of 50% or more in number of headache days between the initial 28-day baseline period and the last 28-day period of the trial.
Secondary outcomes included headache disability (change in PedMIDAS score), reduction in the …
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