Randomized trial of adjunctive topiramate therapy in infants with refractory partial seizures

E. Novotny*, B. Renfroe, N. Yardi, D. Nordli, S. Ness, S. Wang, T. Weber, C. L. Kurland, E. Yuen, M. Eerdekens, L. Venkatraman, J. S. Nye, L. Ford

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

33 Scopus citations


Objective: To evaluate the efficacy and safety of adjunctive topiramate (sprinkle capsules or oral liquid) in reducing daily rates of partial-onset seizures (POS) in infants with refractory POS. Methods: In this double-blind, placebo-controlled, parallel-group, international study, infants (n = 149) with clinical or EEG evidence of refractory POS were randomly allocated (1:1:1:1) to receive adjunctive topiramate 5, 15, or 25 mg/kg/d or placebo for 20 days. The primary variable was the median percentage reductions in daily POS rate from baseline to final assessment as recorded on a 48-hour video-EEG. Results: Of the 149 infants (mean age 12 months) included in the intent-to-treat analysis set, 130 completed the study. Median percentage reduction from baseline in daily POS rate was not significantly different (p = 0.97) between topiramate 25 mg/kg (20.4%) and placebo (13.1%). Lower doses were not formally tested, but nominal p values for comparisons with placebo were not significant (15-mg/kg/d dose: p = 0.97; 5-mg/kg/d dose: p = 0.91). Treatment-emergent fever, diarrhea, vomiting, anorexia, weight decrease, somnolence, and viral infection occurred more frequently (≥10% difference) with topiramate than with placebo. Conclusion: In infants aged 1-24 months, topiramate 5, 15, or 25 mg/kg/d was not effective as adjunctive treatment for refractory partial-onset seizures. No new safety concerns associated with topiramate use were noted. Classification of evidence: This interventional study provides Class I evidence that topiramate 5, 15, or 25 mg/kg/d compared with placebo does not significantly reduce seizure rates in infants aged 1 month to 2 years with refractory partial-onset seizures.

Original languageEnglish (US)
Pages (from-to)714-720
Number of pages7
Issue number9
StatePublished - Mar 2010

ASJC Scopus subject areas

  • Clinical Neurology


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