TY - JOUR
T1 - Safety and tolerability of rufinamide in children with epilepsy
T2 - A pooled analysis of 7 clinical studies
AU - Wheless, James W.
AU - Conry, Joan
AU - Krauss, Gregory
AU - Mann, Allison
AU - Lopresti, Antonia
AU - Narurkar, Milind
PY - 2009/12
Y1 - 2009/12
N2 - Rufinamide is a novel antiepileptic agent recently approved in the United States for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. To help inform clinical decision making, the authors analyzed safety and tolerability data from the entire pediatric population in the rufinamide epilepsy clinical development program. The analysis population comprised 212 rufinamide-treated (age range 3-16 years) and 197 placebo patients (age range 4-17 years) in the double-blind studies, and 391 patients receiving rufinamide in the double-blind and/or open-label extensions. The most common adverse effects observed in rufinamide-treated patients in the double-blind studies were somnolence, vomiting, and headache. Changes in laboratory values, vital signs, and weight were generally clinically insignificant. This pooled analysis of data from pediatric patients in clinical studies of rufinamide for the treatment of seizures, mainly as adjunctive therapy, suggests a favorable safety and tolerability profile in this patient population.
AB - Rufinamide is a novel antiepileptic agent recently approved in the United States for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. To help inform clinical decision making, the authors analyzed safety and tolerability data from the entire pediatric population in the rufinamide epilepsy clinical development program. The analysis population comprised 212 rufinamide-treated (age range 3-16 years) and 197 placebo patients (age range 4-17 years) in the double-blind studies, and 391 patients receiving rufinamide in the double-blind and/or open-label extensions. The most common adverse effects observed in rufinamide-treated patients in the double-blind studies were somnolence, vomiting, and headache. Changes in laboratory values, vital signs, and weight were generally clinically insignificant. This pooled analysis of data from pediatric patients in clinical studies of rufinamide for the treatment of seizures, mainly as adjunctive therapy, suggests a favorable safety and tolerability profile in this patient population.
KW - Epilepsy
KW - Lennox-Gastaut syndrome
KW - Rufinamide
KW - Safety
KW - Seizures
UR - http://www.scopus.com/inward/record.url?scp=75149122341&partnerID=8YFLogxK
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U2 - 10.1177/0883073809350508
DO - 10.1177/0883073809350508
M3 - Article
C2 - 19955344
AN - SCOPUS:75149122341
SN - 0883-0738
VL - 24
SP - 1520
EP - 1525
JO - Journal of child neurology
JF - Journal of child neurology
IS - 12
ER -