This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a double-blind, randomized, two period crossover study comparing the cognitive and behavioral effects of the commonly-prescribed antiepileptic drugs (AEDs) levetiracetam and carbamazepine in normal healthy volunteers. The study consists of 12 visits over a 25 week period. Forty five (45) normal healthy subjects will be treated with both levetiracetam (2000 mg/day) and carbamazepine [adjusted to a dose to obtain mid-range anticonvulsant blood level (ABL) with a target ABL = 8.5 g/ml and a range = 6-12 g/ml) for 8 weeks each. Each AED treatment period will be followed by a four day taper and washout period off AED for the remainder of the month. Cognitive and behavioral function testing along with safety testing will be conducted at pretreatment baseline, the end of each randomization AED maintenance period, and after the final washout period.
SPECIFIC AIMS : The overall aim of the proposed study is to compare the effects of levetiracetam versus carbamazepine on neuropsychologic function after eight weeks treatment in healthy adults. We also plan to compare the safety and tolerability of levetiracetam versus carbamazepine in healthy adults. Hypothesis: Our hypothesis is that the cognitive effects of carbamazepine will be greater than those of levetiracetam.
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