Accumulating data suggest that the antiepilepsy
drug lamotrigine, which has been available for adult use for more than a decade, also confers broad-spectrum, well-tolerated control of
epilepsy in children. The current study--the open-label continuation phase of several short-term clinical trials--was conducted to assess the long-term tolerability and efficacy of
lamotrigine as open-label adjunctive
therapy or monotherapy in pediatric patients for a variety of seizure types and syndromes including
partial seizures, absence
seizures, and
Lennox-Gastaut syndrome.
Clinic visits occurred every 24 weeks throughout the treatment period. A total of 252 patients under 16 years of age were enrolled in the study. The numbers of patients exposed to at least 48 weeks, 96 weeks, and 144 weeks of treatment with
lamotrigine were 185 (73.4%), 119 (47.2%), and 60 (23.8%), respectively, for an average duration of exposure of 96.7 weeks. The most common adverse events considered by the investigator to be
drug related were
dizziness (9.1%),
somnolence (7.9%),
nausea (6.3%),
vomiting (5.2%), and
headache (5.2%). The most common serious adverse events (regardless of suspected cause) included
pneumonia (3.0%) and
infection (1.9%). Investigators judged that the overall clinical status of three-fourths of the patients had improved at treatment weeks 48 and 96 relative to prelamotrigine clinical status.
Lamotrigine administered as monotherapy or adjunctive
therapy for an average of 2 years (96.7 weeks) was well tolerated and effective in pediatric patients with partial or
generalized epilepsy. These results
complement and extend the large body of data demonstrating the tolerability and efficacy of
lamotrigine with short- and long-term use in adults.