Abstracts

RATIONALE: The Keppra[reg] (levetiracetam, LEV) K.E.E.P.E.R. Study is a Phase IV, prospective, open-label clinical trial designed to investigate the safety and efficacy of LEV as add-on therapy in adult patients with partial seizures treated in a community-based neurology practice setting. We now present the final results from this study.
METHODS: Patients enrolled in this 16-week, 5-visit study were to have had between 3 and 42 partial seizures over the 3 months prior to study entry. Patients had to have been on at least one, but no more than, 2 concomitant AEDs at study entry, and these were to have been stable for at least 4 weeks before the first visit. Patients were to have completed seizure diaries throughout the course of the study. Patient demographics, responder rate ([gte]50% reduction from baseline seizure frequency), partial seizure freedom, incidence of adverse events, and Global Evaluation Scale (GES) assessment (an investigator-completed clinical impression rating) were calculated and reported.
RESULTS: For the 1,030 patients included in the ITT analysis, the mean age at study entry was 42.2 years; race was predominantly Caucasian (77.8%), with more females (54.6%) than males (44.7%). The mean monthly baseline seizure frequency was 5.0 (range 0.0 [ndash] 46.4). There were 747 (72.5%) patients who completed the study; 12.9% of patients withdrew due to adverse events. Overall, there was a 57.9% responder rate, a 62.3% median percent reduction in partial seizures and 20% of patients achieved complete partial seizure freedom. During the final 6 weeks of treatment the responder rate was 66.7%, and 42.1% of patients achieved complete partial seizure freedom. The overall profile of adverse events is similar to that seen in the levetiracetam clinical development program. The most frequently reported adverse events were somnolence, dizziness, asthenia and headache. Adverse events categorized as behavior related were reported at a rate lower than that seen in the levetiracetam clinical development program. The investigator-reported GES data indicated that 74.3% of patients had an overall clinical improvement from their baseline status. Of these patients, 26.0% showed moderate improvement (second highest rating) and 37.0% showed marked improvement (highest rating).
CONCLUSIONS: These results suggest that in a community setting the safety profile of LEV is similar to that seen in the clinical development program with no new adverse findings. These results also suggest a greater degree of efficacy when LEV is used in this setting, perhaps reflecting a more [dsquote]typical[dsquote] epilepsy patient than those enrolled in Phase III trials.
[Supported by: UCB Pharma, Inc.]; (Disclosure: Salary - L Magnus and A Herbeuval are employed by UCB Pharma, Inc., Honoraria - M Morrell, J Ferrendelli, J French and I Leppik receive honoraria for speaking from UCB and other pharmaceutical companies.)