Abstracts

Rationale: Previous research into in utero exposure to antiepileptic drugs (AEDs) has found that older AEDs may impact upon the cognitive and developmental abilities of children exposed to them. Research into the cognitive and developmental effects of in utero exposure to novel AEDs has such as Levetiracetam has thus far, not been reported. This study aims to assess the developmental abilities of children aged between 0-2 years exposed to Levetiracetam in utero. Methods: 38 Children exposed in utero to monotherapy Levetiracetam were prospectively enrolled on to the UK Epilepsy and Pregnancy Register before birth. Developmental ability was assessed using the Griffiths Mental Development Scales (GMDS)- Revised: birth to 2 years. A control group of children previously collected by the Liverpool and Manchester Neurodevelopment group were utilized. These control children were born to mothers without epilepsy who were not taking medication, and were also assessed using the GMDS 0-2years. All mothers were assessed using the National Adult Reading Test (NART) in order to gain a surrogate measure of IQ. The Levetiracetam exposed children were then matched on maternal IQ to the control group of children and their overall development scores were compared. Results: The GMDS looks at various different aspects of development and gives an overall development score. Analysis of the individual subscales showed that there was no significant differences between children exposed to Levetiracetam and controls for locomotor tasks (p=0.184, m=96.95 vs m=100.6), personal & social tasks (p=0.394, m=101.5 vs m=98.62), hearing & language tasks (p=0.481, m=101.21 vs m=99.09) and performance tasks (p=0.110, m=105.58 vs m=100.6) Children exposed to Levetiracetam scored significantly higher than controls on tasks of hand and eye coordination (p=0.01, m=106.68 vs m=93.14). This did not impact on the overall development of children exposed to monotherapy Levetiracetam with no significant difference found between children exposed to Levetiracetam and control children on the overall development score (p=0.128, m= 102.34 vs m=98.57). Conclusions: The preliminary results suggest that exposure to Levetiracetam in utero does not affect the overall development of children under the age of two years. Caution is needed in interpreting the preliminary results of this study due the small sample size and young age of the children. Data collection for this study is on-going.