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Acta Neurol. Scand. · Sep 2006
Multicenter Study Clinical TrialLevetiracetam: a long-term follow-up study of efficacy and safety.
- J Bauer, E Ben-Menachem, G Krämer, W Fryze, S Da Silva, and D G A Kasteleijn-Nolst Trenité.
- Universitätsklinikum Bonn, Klinik für Epileptologie, Bonn, Germany. juergen.bauer@ukb.uni-bonn.de
- Acta Neurol. Scand. 2006 Sep 1; 114 (3): 169-76.
ObjectivesTo evaluate the efficacy and safety of long-term add-on treatment with levetiracetam 1,000-4,000 mg/day.Patients And MethodsIn this multicenter, open-label follow-up study, 505 patients, from 10 European countries, who had benefited from previous add-on treatment with levetiracetam in a clinical trial or compassionate-use program were enrolled; 274 (54.3%) stayed to the end. Most then continued levetiracetam by prescription or in a named patient program, where it was not yet commercially available. Mean treatment duration was 1,045 days (range: 24 days to >7 years). Median daily dosage was 3,000 mg/day (range: 250-6,000 mg/day), with 250 (49.5%) patients receiving levetiracetam for >3 years.ResultsMedian total and partial seizure frequency per week over the evaluation period were 0.8 and 0.7; seizure frequency per week was generally stable over time and remained low. There was a probability of 6.6% of remaining seizure-free for the first 3 years, and of 18.9% of having a seizure-free period of at least 3 years at any time. Most adverse events were mild or moderate and unrelated to study drug. Levetiracetam was well tolerated, and provided stable seizure control during long-term treatment.
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