Lamotrigine in Pediatric Epileptology: Long-Term Profile of Cognition and Vigilance in 120 Patients (the L-Child Project)

Purpose: The aim of this study was to determine the long-term profile of cognition and vigilance under lamotrigine (LTG) monotherapy and add-on therapy over a mean period of 2.5 years. Methods: Retrospective data were acquired through (i) structured interviews with epileptologists and (ii) structured parent interviews. Data on LTG dosage, co-medication, seizure frequency, EEG, effects, adverse effects, and epidemiological data were collected and stored in a database. Improvement or worsening of cognition and vigilance were rated on a 5-point scale 1) before any treatment with LTG; 2) during the dose-in phase; 3) during the targeted dosage; and 4) during the individual optimal dosage. Here, we report the epileptologist's rating. Results: N=120 therapies (mono N=20, add-on N=100) were evaluated. Mean age of patients was 8.7 years, mean duration of treatment 2.5 years. Distribution of epilepsies was: idiopathic epilepsies 16%, symptomatic epilepsies 62%, unclassified epilepsies 22%. Cognition was not altered in 75% of cases, improved in 16% and worsened in 8% cases compared to the time before LTG. Vigilance was rated as unchanged in 80%, improved in 9% and worsened in 2%. Adverse effects were reported in 44%. 2 cases had severe adverse events, one patient experienced toxic hepatic failure, another petechiae. All adverse events were reversible. 26% dropped out before the optimal dosage range could be established. Conclusion: In the epileptologists' view safe long-term profiles for cognition and vigilance can be observed under LTG therapy. Adverse effects were in almost all cases of mild character and always reversible.