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From the Dallas Pediatric Neurology Associates (Dr. Elterman), Dallas, TX; Division of Pediatric Neurology (Dr. Glauser), Children’s Hospital Medical Center, Cincinnati, OH; Cleveland Clinic Foundation (Dr. Wyllie), OH; Corporate Office Science and Technology (Dr. Reife), Johnson & Johnson, New Brunswick, NJ; The R.W. Johnson Pharmaceutical Research Institute (Drs. Wu and Pledger), Raritan, NJ; and the Topiramate YP Study Group.
Address correspondence and reprint requests to Dr. Roy Elterman, Dallas Pediatric Neurology Associates, 12801 North Central Expressway, Plaza 3, Suite 580, Dallas, TX 75230.
OBJECTIVE: To evaluate the efficacy and safety of topiramate 6 mg/kg/day in children (age 2 to 16 years) as adjunctive therapy for uncontrolled partial-onset seizures with or without secondarily generalized seizures in a multicenter, randomized, double-blind, placebo-controlled trial.
METHODS: Patients with at least six partial-onset seizures during the 8-week baseline phase were treated with either topiramate (n = 41) or placebo (n = 45) for 16 weeks.
RESULTS: Topiramate-treated patients had a greater median percent reduction from baseline in average monthly partial-onset seizure rate than placebo-treated patients (33.1% versus 10.5%, p = 0.034), a greater proportion of treatment responders (i.e., patients with a 
50% seizure rate reduction; 16 of 41 [39%] versus 9 of 45 [20%], p = 0.080), and patients with a 75% seizure rate reduction (7 of 41 [17%] versus 1 of 45 [2%], p = 0.019), and better parental global evaluations of improvement in seizure severity (p = 0.019). Emotional lability (12% versus 4%), fatigue (15% versus 7%), difficulty with concentration or attention (12% versus 2%), and forgetfulness/impaired memory (7% versus 0%) were more frequent among topiramate-treated than placebo-treated patients. Most treatment-emergent adverse events were mild or moderate in severity. No topiramate-treated patients discontinued the study due to adverse events.
CONCLUSIONS: Topiramate was safe and effective in the treatment of partial-onset seizures in children.
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