An Early View of Results from the K.E.E.P.E.R. Trial: A Phase IV Community-Based Clinical Trial Investigating Levetiracetam as Add-On Therapy in Partial-Onset Seizures.
Abstract number :
2.162
Submission category :
Year :
2001
Submission ID :
2759
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
I.E. Leppik, MD, Neurology, MINCEP Epilepsy Care, Minneapolis, MN; J.A. French, MD, Neurology, Hospital of University of Pennsylvania, Philadelphia, PA; J.A. Ferrendelli, MD, Neurology, University Texas - Houston School of Medicine, Houston, TX; M.G. Kato
RATIONALE: The [underline]K[/underline]eppra[tm] (levetiracetam, LEV) [underline]E[/underline]pilepsy [underline]E[/underline]valuation of [underline]P[/underline]atient tim[underline]E[/underline] to [underline]R[/underline]esponse (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 patients with partial seizures treated in a community-based neurology practice setting. A preliminary analysis of the clinical data from a subset of patients is provided in advance of the final study report. The data used were extracted from a partial, unlocked database. Enrollment was completed on January 24, 2001 with final study results expected in late 2001.
METHODS: Patients enrolled through August 31, 2000 were included the analysis. Case Report Form data for 577 patients (240 investigators) was available. This represents slightly more than half of the patients enrolled. Patient demographics, responder rate (defined as [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 this subset of patients, the mean age at study entry was 42 ([plusminus]14) years; race was predominately Caucasian (81%), with 56% female and 43% male. The mean baseline weekly seizure frequency was 1.4 (SD [plusminus]4.14). The withdrawal rate was 23%, with 11% attributed to adverse events. Of the 577 patients, 441 completed the entire treatment period with analyzable seizure data at the final visit timepoint. Of those 441 patients, 67% demonstrated [gte]50% reduction in partial seizures compared to baseline weekly seizure frequency and 41% achieved complete partial seizure freedom during the final six weeks of treatment. The overall profile of reported adverse events is similar to that seen in the levetiracetam clinical development program with the most frequently reported events being dizziness, drowsiness, headache and fatigue. The investigator-reported GES data indicated that 429 (74%)of patients had an overall clinical improvement from their baseline status. Of these patients, 28% showed moderate improvement (second highest rating) and 36% showed marked improvement (highest rating).
CONCLUSIONS: These preliminary results suggest that in a community setting the safety profile of LEV is similar to that seen in the clinical development program. These results also suggest a greater degree of efficacy when LEV is used in this setting. Correlation of these findings with the final study results will follow completion of the clinical phase and full data analysis. It is anticipated that similar results will be observed.
Support: UCB Pharma
Disclosure: Salary - Katos -UCB Pharma; Honoraria - UCB Pharma