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Topiramate Monotherapy in Newly Diagnosed Epilepsy in Children and Adolescents

Division of Neurology, Children's Hospital Medical Center, Cincinnati, Ohio, tracy.glauser{at}cchmc.org

Dennis J. Dlugos, MD, MSCE

Division of Neurology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

W. Edwin Dodson, MD

St. Louis Children's Hospital and Departments of Neurology and Pediatrics, St. Louis, Missouri

Augusto Grinspan, MD

Fundacion Pro Neurociencias, Rio Cuarto, Argentina

Steven Wang, PhD

Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, New Jersey

Shu-Chen Wu, PhD

Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, New Jersey

and the EPMN-106/INT-28 Investigators

A double-blind, dose-controlled study evaluated topiramate as monotherapy in 470 patients with newly diagnosed ( 3 months) epilepsy or epilepsy relapse in the absence of therapy. In addition to having at least 2 lifetime-unprovoked seizures, patients had 1 or 2 partial-onset seizures or generalized-onset tonic-clonic seizures during a 3-month retrospective baseline. The trial included a large cohort (N = 151, 32%) of children and adolescents 6 to 15 years of age. Eligible patients were randomized to treatment groups in which topiramate was titrated to target maintenance dosages of either 400 mg/day (n = 77) or 50 mg/day (n = 74). Patients were followed for at least 6 months. Based on Kaplan-Meier analyses, the primary efficacy endpoint of time to first seizure favored the higher topiramate dose in both the overall population and the cohort of children/adolescents. The probability that children/adolescents remaining in the study were seizure free at 6 months was 78% in the 50-mg target dose group and 90% with the higher dose. At 12 months, the probability of being seizure free was 62% and 85%, respectively. The incidence of treatment-limiting adverse events was 4% in the 50-mg target dose group and 14% in the group assigned to 400 mg as a target dose. The most common adverse events, excluding typical childhood illnesses, were headache, appetite decrease, weight loss, somnolence, dizziness, concentration/attention difficulty, and paresthesia. As shown in this subset analysis, topiramate is effective and well tolerated as monotherapy in children and adolescents.

Key Words: topiramate • epilepsy

Journal of Child Neurology, Vol. 22, No. 6, 693-699 (2007)
DOI: 10.1177/0883073807303997


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