Topiramate: new indication. A bulkier assessment file

(1) The licensed indications of topiramate have been extended to cover treatment (in combination with an inadequately effective ongoing treatment) of generalised tonic-clonic epilepsy in adults and children over four years, and partial epilepsy in children over four. (2) The efficacy of topiramate was established in two double-blind, placebo-controlled trials in patients with generalised tonic-clonic epilepsy, and in a double-blind, placebo-controlled trial in patients with partial epilepsy. (3) Topiramate has not been compared with other antiepileptics with similar indications, i.e. lamotrigine and vigabatrin. (4) Topiramate appears to be relatively well tolerated.