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Clinical Trials Update
December 27, 2016

Still No Migraine Relief for Kids

JAMA. 2016;316(24):2589. doi:10.1001/jama.2016.19352

For the more than 6 million US children and adolescents with migraines, the bad news is that they’ll have to wait for effective treatment. A phase 3 trial of the commonly used pediatric prevention medications amitriptyline and topiramate concluded early when the drugs were found less effective than placebo.

While the trial was in progress, the US Food and Drug Administration approved topiramate for treating episodic migraine in adolescents, prompting the study’s authors to recommend reexamining the drug’s use to prevent pediatric migraine. The trial included 361 children aged 8 to 17 years. Patients were randomly assigned in a 2:2:1 ratio to receive oral amitriptyline, topiramate, or placebo. Doses escalated every 2 weeks over a period of 8 weeks, followed by a 16-week constant-dose phase. Patients tracked their headache frequency and disability in a daily diary.

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