Reviews / Epilepsy Research 68 (2006) 19–94 45 or tolerance. Seizure types are clinically counted and prolonged video EEG is an integral measurement. Out- come variables include seizure reduction, tolerability, and time continued on AED. Escape criteria such as those proposed in the partial onset seizure study above, and the allowance of rescue therapy are a necessity to study these children. Because the encephalopathic epilepsies of childhood are refractory to many existing therapies, newer models must be devised and accepted (see Jensen). Translational research studies, however, must be performed in well-defined patients with struc- tured observations and endpoints. Large numbers of subjects will need to be entered to obtain data necessary for differentiating the efficacy and tolerability of these drugs in what is more typically rare age related syn- dromes. Response to treatment may also be age related or seizure type dependent during the evolution of the epilepsy and neurodevelopment of the child. 3. Conclusion In conclusion, the study of new AEDs in neonates and infants remains a challenge. Epilepsy itself has dif- ferent etiologies and clinical manifestations in these young children. Pharmacokinetics, pharmacodynamics and underlying neurochemistry and developing sys- tems require specific testing in appropriate infants with refractory seizures. The designs for study out- lined above, with one now being conducted and the others proposed, should allow further delineation and improvement in the treatment of epilepsy in neonates and young infants. Reference Engel, J., 2001. A proposed diagnostic scheme for people with epileptic seizures and with epilepsy: report of the ILAE task force on classification and terminology. Epilepsia 42, 796–803. Glauser, T.A., Miles, M.V., Tong, P., et al., 1999. Topiramate phar- macokinetics in children. Epilepsia 40, 788–791. Ko, T.S., Holmes, G.L., 1999. Predictors of medically intractable childhood epilepsy. Neurophysiology 110, 1245–1251. Nordli Jr., D.R., Bazil, C.W., Scheuer, M.L., Pedley, T.A., 1997. Recognition and classification of seizures in infants. Epilepsia 38, 553–560. Pellock, J.M., 1999. Managing pediatric epilepsy syndromes with new antiepileptic drugs. Pediatrics 104, 1106–1116. Pellock, J.M., 1998. Pediatric trials: practical issues. Special popu- lations and trial design. In: French, J., Leppik, I., Dichter, MA. (Eds.), Antiepileptic Drug Development: Advances in Neurol- ogy. Lippincott-Raven, Philadelphia, PA, pp. 167–171. Sheridan, P.H., Jacobs, M.P., 1996.The development of antiepileptic drugs for children. Report from the NIH Workshop, Bethesda, MD, 17–19 February 1994. Epilepsy Res. 23, 87–92. doi:10.1016/j.eplepsyres.2005.09.017 Antiepileptic drug trials in the elderly I. Leppik Abstract It is important to perform clinical trials of antiepilep- tic drugs (AEDs) in elderly because they differ in many ways from younger people. The response of elderly people to AEDs may not be predictable from studies focused exclusively on younger adults. Major issues of concern include altered absorption and metabolism, as well as the likelihood of interactions with concomitant medications. Contents 1. Introduction ........................... 45 2. Characteristics of elderly ............... 46 3. Drug studies in elderly .................. 47 4. Effect of age on epilepsy and drug metabolism ............................ 47 5. Drug interactions ...................... 47 6. Conclusions ........................... 48 Acknowledgement ..................... 48 References ............................ 48 1. Introduction There are many reasons to perform clinical trials of antiepileptic drugs (AEDs) in the elderly. Perhaps the most compelling is that the elderly are different from younger adults, and that response to AEDs may not be predictable from studies focused exclusively on persons younger than 65 years of age. Another reason is that the population of the planet is aging, and the elderly will represent a larger number of patients. A more personal reason is that we are aging, and some of us may need to be treated with AEDs. Demographic