Neither drug was better than placebo at preventing headaches in this randomized trial, and both drugs were associated with higher rates of some adverse events.
Although amitriptyline and topiramate are commonly used to treat pediatric migraine, there is no FDA-approved treatment for children younger than 12. Researchers at 31 U.S. sites randomized 361 children aged 8 to 17 years with migraine to amitriptyline (1 mg/kg per day), topiramate (2 mg/kg per day), or placebo for 24 weeks. The trial was stopped early for futility.
Patients kept a symptom diary for 28 days before randomization and for the last 28 days of the trial. The primary outcome was a 50% or greater relative reduction in the number of headache days between the two periods. Analyses were adjusted for age (8–12 vs. 13–17) and headache frequency during the baseline period (episodic, 4–14 vs. chronic, ≥15).
Rates of the primary outcome wer…