The FDA has approved Topamax (topiramate; Janssen) for migraine prophylaxis in adolescents aged 12–17 years old. This is the first drug approval for a migraine prophylactic in this age group.

The safety and effectiveness in preventing migraine headaches in adolescents (ages 12–17) was established in a clinical trial that enrolled 103 patients. Treatment with Topamax resulted in a decrease in migraine frequency of about 72% compared to 44% in participants that were treated with placebo.

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Topamax is already approved as initial monotherapy and adjunct in partial-onset or primary generalized tonic-clonic seizures; as adjunct in Lennox-Gastaut syndrome; and for migraine prophylaxis in adults.

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