The efficacy and safety of topiramate (TPM) (6 mg/kg/day) in children age 2 to 16 years, as adjunctive therapy for uncontrolled partial-onset seizures (75% complex partial), with or without secondarily generalized seizures, were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial, organized by the Topiramate YP Study Group. Comparing 41 TPM-treated with 45 patients receiving placebo, the TPM group showed a greater median percent reduction from baseline in the average monthly partial-onset seizure rate (33% versus 10%, p=0.034), a greater proportion with a >50% seizure reduction (39% versus 20%, p=0.08) or >75% seizure reduction (17% versus 2%, p=0.019), and better parental evaluations of lessened seizure severity (p=0.019). Adverse effects occurring more frequently among TPM treated than placebo-treated children included emotional lability (12% vs 4%), fatigue (15% vs 7%), impaired attention (12% vs 2%), and impaired memory (7% vs 0%). Side-effects were not sufficiently severe to require discontinuation of therapy. TPM was considered safe and effective as an adjunctive treatment of partial-onset seizures in children. [1]

COMMENT. In addition to trials in children with partial seizures, topiramate (6 mg/kg/day) as adjunctive therapy has been tested and proven effective and well-tolerated in children and adults with primary generalized tonic-clonic seizures. [2]