Patients with focal epileptic seizures with or without generalization who are at present treated with one or two antiepileptic drugs are eligible for this study, provided that they fulfill all inclusion criteria and none of the exclusion criteria. Following a baseline phase of 8 weeks duration, the patients are randomised and they receive an initial daily dose of 50 mg zonisamide during the first week. The daily dose is then increased to 200 mg zonisamide in group A or 400 mg zonisamide in group B, respectively. After eight weeks of treatment, the daily dose in group A can be increased to 300 mg in case of insufficient efficacy. Control assessments are performed at the beginning of the study and at the end of the prospective baseline phase, if applicable and after 4, 8, 12, and 16 weeks. At the end of the first, second, and third treatment week, and at the end of week six, the patient is additionally contacted by telephone. Efficacy and safety parameters are assessed at baseline, during all control visits, and at the end of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
157
Intravenous injection; initial daily dose of 50 mg zonisamide (2x25 mg) in both treatment groups; following a prospective or retrospective baseline phase of 8 weeks the study drug will be administered twice daily during 16 consecutive weeks.
Epilepsieklinik Tabor
Bernau bei Berlin, Brandenburg, Germany
Universtitatsklinikum Bonn
Bonn, Nordrhein-Westphalen, Germany
Universtitatsklinikum Munster, Klinik und Poliklinik fur Neurologie
Münster, Nordrhein-Westphalen, Germany
Epilepsiezentrum Bethel/KSE
Beilefeld, Germany
Institut fur Diagnostik der Epilepsien Gmbh
Berlin, Germany
Change in number of epileptic seizures between week 13 and 16 after start of treatment compared to the correspondently normalized base-line phase.
Time frame: 28 days
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Charite Campus Virchow-Klinikum, Neurologische Klinik und Poliklinik
Berlin, Germany
St. Josephs Hospital, Neurologische Klinik
Bochum, Germany
Dr. Gunther Schumann
Bochum, Germany
Knappschaftskrankenhaus Bochum-Langendreer, Neurologische Klinik
Bochum, Germany
Dr. Hans Martin Kolbinger
Bonn, Germany
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