Levetiracetam in a broad population of patients with refractory epilepsy: interim results of the international SKATE trial

Authors: Genton, P.¹; Sadzot, B.²; Fejerman, N.³; Peltola, J.⁴; Despland, P.-A.⁵; Steinhoff, B.⁶; Rektor, I.⁷; Wroe, S.⁸; Maubrey, M.-C.⁹; Vandervelden, C.¹⁰; van Hammée, G.¹⁰; Schlit, A.-F.¹⁰; van Paesschen, W.¹¹

Source: Acta Neurologica Scandinavica, Volume 113, Number 6, June 2006 , pp. 387-394(8)

Publisher: Blackwell Publishing

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Abstract:

Genton P, Sadzot B,Fejerman N, Peltola J, Despland P-A, Steinhoff B, Rektor I, Wroe S, Maubrey M-C, Vandervelden C, van Hammée G, Schlit A-F, van Paesschen W. Levetiracetam in a broad population of patients with refractory epilepsy: interim results of the SKATE trial.

Acta Neurol Scand 2006: 113: 387–394.

To prospectively assess the safety and efficacy of levetiracetam in patients with uncontrolled focal epilepsy, in a common practice-based setting. Patients and methods –

In this phase IV, open-label, 16-week community-based study, adult patients with focal seizures initially received levetiracetam 1,000 mg/day. Throughout the study, the dose was adjusted in increments of 1,000 mg (maximum 3,000 mg/day) to achieve seizure control and maintain tolerability. The outcome parameters were the percentage reduction in partial and total seizure frequency per week from historical baseline, global evaluation scale (GES), and adverse events (AE). Results –

Seven hundred and thirty-one patients were included in this analysis and 84.4% completed the study. The median percent reduction in all seizures was 47.8%, and 49.3% for all partial seizures. The 50% responder rate was 49%, and the seizure-free rate was 17.2% for all partial seizures. Approximately 60% of patients showed moderate to marked improvement on the GES. The majority of AE were of mild to moderate severity; the most commonly reported being asthenia, somnolence, headache, and dizziness. Conclusion –

Levetiracetam is both efficacious and safe as an add-on therapy in patients with refractory epilepsy treated by clinicians in their daily practice.

Keywords: levetiracetam; focal epilepsy; clinical trial; open-label

Document Type: Research article

DOI: 10.1111/j.1600-0404.2006.00647.x

Affiliations: 1: Hôpital Henri Gastaut-Centre Saint Paul, Marseille, France 2: CHU Sart-Tilman, Service Neurologie, Liège, Belgium 3: Hospital de Pediatria ''Prof. Juan P. Garrahan”; Servicio de Neurologia, Buenos Aires City, Argentina 4: Finn Medi tutkimus Oy, Tampere, Finland 5: CHUV, Unité d'explorations fonctionnelles EEG-EMB, Service de Neurologie, Lausanne, Switzerland 6: Epilesiezentrum Kork, Kehl-Kork, Germany 7: FNsP U svate Anny, Brno, Czech Republic 8: Ipswich Hospital NHS Trust, Department of Clinical Neurology, East Anglia, UK 9: UCB Pharma, Brussels, Belgium 10: UCB Pharma, Chemin du Foriest, Belgium 11: Universitair Hospitaal Gasthuisberg, Neurology and Epileptology, Leuven, Belgium

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