Abstracts

Rationale: RATIONALE: Levetiracetam (LEV) is a second generation AED with indications for the adjunctive treatment of partial onset seizures, JME, and primary generalized tonic-clonic seizures in adults and children with epilepsy. However, there is much less data available for older adults, and no prospective clinical trial data are currently available. Within the elderly population, it is increasingly recognized that the prevalence of seizures is increased. Moreover, data establishes that AEDs can adversely affect balance potentially increasing the risk for falls. Falls represent a significant risk of mortality and morbidity in elderly. The use of AEDs in the elderly must consider the effects of a medication on balance. This study evaluated cognitive, mood, and balance effects of LEV in a volunteer sample of healthy community living older adults aged 65-80 years old.Methods: METHODS: The study used a randomized, double-blind, placebo-controlled, crossover design. To date, 18 older adults (mean age = 72.1 yrs old) completed the study. The sample was predominantly Caucasian (61%) and female (61%). Subjects received either LEV or placebo for 5 wks (2 wks of dose escalation, 2 wks of maintenance therapy, and 1 wk taper). Target maintenance dose was 1,000 mg/day (dosed bid). Evaluations were conducted at Screening, baseline at randomization, end of the First Maintenance Phase, at cross-over, and Second Maintenance Phase. Balance evaluation was completed using the Berg Balance Test at each visit. In addition, neuropsychological evaluation of attention, memory, language, and executive functioning were administered as well as subjective mood measures. The study is not completed (Total target N = 20), and rather than breaking blind to the investigators, comparisons were made between all participants during drug phase versus all participants on placebo phase by a neutral third party. Repeated measures ANOVA was conducted to evaluate for treatment effects.Results: RESULTS: No serious adverse events have occurred and all participants were ambulatory. Serum concentrations of LEV demonstrated compliance. Analyses did not reveal any significant differences in Berg Balance test scores between the treatment phase and placebo phase (p>.05). Correlation among dose concentrations and balance was conducted. Conclusions: CONCLUSION: LEV had little impact on an objective measure of balance in this sample of older community living adults. These data provide initial support for LEV as an adjunctive medication in the treatment of older adults with seizures. Funding supported by: UCB Inc.