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Long-term Tolerability and Efficacy of Lamotrigine in Infants 1 to 24 Months Old

Vanderbilt University, Nashville, Tennessee, eric.pina-garza{at}vanderbilt.edu

Roy D. Elterman, MD

Dallas Pediatric Neurology Associates, Dallas, Texas

Ricardo Ayala, MD

Tallahassee Neurological Clinic, Florida

Maria Corral, MD

Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina

Mohamad A. Mikati, MD

American University Medical Center, Beirut, Lebanon

Mary J. Piña-Garza, RN, MSN

Vanderbilt University, Nashville, Tennessee

Clay R. Warnock

Neuroscience Medicine Development Center GlaxoSmithKline, Research Triangle Park, North Carolina

Heather S. Conklin

Neuroscience Medicine Development Center GlaxoSmithKline, Research Triangle Park, North Carolina

John A. Messenheimer, MD

Neuroscience Medicine Development Center GlaxoSmithKline, Research Triangle Park, North Carolina

This open-label study was designed to evaluate the long-term tolerability and efficacy of lamotrigine in 1- to 24-month-old infants with partial seizures. The study enrolled both lamotrigine-naïve patients and patients who had been previously exposed to lamotrigine in a randomized, double-blind, placebo-controlled study. Patients (n = 204) received lamotrigine according to a dosing schedule that depended on prior experience with lamotrigine and concurrent antiepileptic drug therapy for up to 48 weeks or their second birthday, whichever occurred last. Total duration of lamotrigine exposure (which included exposure during the placebo-controlled study in lamotrigine-experienced patients) was 24 weeks in 92% of patients, 48 weeks in 70% of patients, and 72 weeks in 20% of patients. A total of 20 (10%) patients (8 lamotrigine-naïve patients and 12 lamotrigine-experienced patients) transitioned to lamotrigine monotherapy. The most common adverse events were pyrexia (45% of patients), upper-respiratory tract infection (28%), and ear infection (22%). The only adverse event considered reasonably attributable to study medication in >2% of patients was irritability (n = 10; 5% of patients). No cases of serious rash were reported. The median percent reduction from baseline in partial seizure frequency in the sample as a whole was 74%. Seizure frequency was reduced by 50% from pre-lamotrigine baseline in 62% of patients in the sample as a whole, 60% of the lamotrigine-naïve subgroup, and 63% of the lamotrigine-experienced subgroup. In the sample as a whole, 13% of patients were seizure free during the Treatment Phase. Investigators considered clinical status at the last clinic visit to be improved (mildly, moderately, or markedly) relative to prelamotrigine clinical status in 76% of patients (150/197) and to be unchanged in 19% (37/197). In this study—the first large prospective investigation of the long-term tolerability and efficacy of an antiepileptic drug in a patient population 2 years and younger—lamotrigine administered for up to approximately 72 weeks was well tolerated and associated with good seizure control.

Key Words: lamotrigine • epilepsy • partial seizures • clinical trial

Journal of Child Neurology, Vol. 23, No. 8, 853-861 (2008)
DOI: 10.1177/0883073808317348


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