TY - JOUR
T1 - Adjunctive therapy with oxcarbazepine in children with partial seizures
AU - the Oxcarbazepine Pediatric Study Group
AU - Glauser, Tracy A.
AU - Nigro, M.
AU - Sachdeo, R.
AU - Pasteris, L. A.
AU - Weinstein, S.
AU - Abou-Khalil, B.
AU - Frank, L. M.
AU - Grinspan, A.
AU - Guarino, T.
AU - Bettis, D.
AU - Kerrigan, J.
AU - Geoffroy, G.
AU - Mandelbaum, D.
AU - Jacobs, T.
AU - Mesenbrink, P.
AU - Kramer, L.
AU - D'Souza, J.
AU - Andrews, Richard V.
AU - Barros, Marcelo Devilat
AU - Bebin, Martina
AU - Beierwnltes, Pat
AU - Berkovic, Samuel
AU - Bonet, H. B.
AU - Bourgeois, Blaise F.D.
AU - Carmant, Lionel
AU - Clark, Peggy
AU - Cooper, Alyse
AU - D'Cruz, O'Neill
AU - de Arbelaiz, Roberto
AU - Delgado, Mauricio
AU - Edwards, Keith
AU - Farrell, Kevin
AU - Fakhoury, Toufic A.
AU - Grattan-Smith, Padraic
AU - del Carmen Fernandez Freire, Maria
AU - Grippo, Jorge
AU - Harvey, Simon
AU - Hammerschmidt, Pablo
AU - Jackson, Sandra
AU - Knrolychvk, Mary Ann
AU - Keene, D. L.
AU - Kiviti, Sarah
AU - Avendano Kunstmann, Maria Leonor
AU - Lantwicki, Linda
AU - Latorre, Thomas Mesa
AU - Leppik, Ho E.
AU - Manzi, Ruben
AU - Masih, Maria Elena
AU - May, William N.
AU - Steinberg, Avraham
PY - 2000/6/27
Y1 - 2000/6/27
N2 - Objective: To evaluate the safety and efficacy of oxcarbazepine (OXC) as adjunctive therapy in children with inadequately controlled partial seizures on one or two concomitant antiepileptic drugs (AEDs). Background: OXC has shown antiepileptic activity in several comparative monotherapy trials in newly diagnosed patients with epilepsy, and in a placebo-controlled monotherapy trial in hospitalized patients evaluated for epilepsy surgery. Design: A total of 267 patients were evaluated in a multicenter, randomized, placebo-controlled trial consisting of three phases: 1) a 56-day baseline phase (patients maintained on their current AEDs); 2) a 112-day double-blind treatment phase (patients received either OXC 30-46 mg/kg/day orally or placebo); and 3) an open-label extension phase. Data are reported only from the double-blind treatment phase; the open-label extension phase is ongoing. Methods: Children (3 to 17 years old) with inadequately controlled partial seizures (simple, complex, and partial seizures evolving to secondarily generalized seizures) were enrolled. Results: Patients treated with OXC experienced a significantly greater median percent reduction from baseline in partial seizure frequency than patients treated with placebo (p = 0.0001; 35% versus 9%, respectively). Forty-one percent of patients treated with OXC experienced a ≥50% reduction from baseline in partial seizure frequency per 28 days compared with 22% of patients treated with placebo (p = 0.0005). Ninety-one percent of the group treated with OXC and 82% of the group treated with placebo reported ≥1 adverse event; vomiting, somnolence, dizziness, and nausea occurred more frequently (twofold or greater) in the group treated with OXC. Conclusion: OXC adjunctive therapy administered in a dose range of 6 to 51 mg/kg/day (median 31.4 mg/kg/day) is safe, effective, and well tolerated in children with partial seizures.
AB - Objective: To evaluate the safety and efficacy of oxcarbazepine (OXC) as adjunctive therapy in children with inadequately controlled partial seizures on one or two concomitant antiepileptic drugs (AEDs). Background: OXC has shown antiepileptic activity in several comparative monotherapy trials in newly diagnosed patients with epilepsy, and in a placebo-controlled monotherapy trial in hospitalized patients evaluated for epilepsy surgery. Design: A total of 267 patients were evaluated in a multicenter, randomized, placebo-controlled trial consisting of three phases: 1) a 56-day baseline phase (patients maintained on their current AEDs); 2) a 112-day double-blind treatment phase (patients received either OXC 30-46 mg/kg/day orally or placebo); and 3) an open-label extension phase. Data are reported only from the double-blind treatment phase; the open-label extension phase is ongoing. Methods: Children (3 to 17 years old) with inadequately controlled partial seizures (simple, complex, and partial seizures evolving to secondarily generalized seizures) were enrolled. Results: Patients treated with OXC experienced a significantly greater median percent reduction from baseline in partial seizure frequency than patients treated with placebo (p = 0.0001; 35% versus 9%, respectively). Forty-one percent of patients treated with OXC experienced a ≥50% reduction from baseline in partial seizure frequency per 28 days compared with 22% of patients treated with placebo (p = 0.0005). Ninety-one percent of the group treated with OXC and 82% of the group treated with placebo reported ≥1 adverse event; vomiting, somnolence, dizziness, and nausea occurred more frequently (twofold or greater) in the group treated with OXC. Conclusion: OXC adjunctive therapy administered in a dose range of 6 to 51 mg/kg/day (median 31.4 mg/kg/day) is safe, effective, and well tolerated in children with partial seizures.
KW - Adjunctive therapy
KW - Oxcarbazepine
KW - Partial seizures Antiepileptic drugs
KW - Pediatric epilepsy
KW - Trileptal
UR - http://www.scopus.com/inward/record.url?scp=18844471793&partnerID=8YFLogxK
U2 - 10.1212/wnl.54.12.2237
DO - 10.1212/wnl.54.12.2237
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C2 - 10881246
AN - SCOPUS:18844471793
SN - 0028-3878
VL - 54
SP - 2237
EP - 2244
JO - Neurology
JF - Neurology
IS - 12
ER -