Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization
- Registration Number
- NCT00165828
- Lead Sponsor
- Eisai GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 157
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Zonegran - 2 Zonegran -
- Primary Outcome Measures
Name Time Method Change in number of epileptic seizures between week 13 and 16 after start of treatment compared to the correspondently normalized base-line phase. 28 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Epilepsieklinik Tabor
🇩🇪Bernau, Brandenburg, Germany
Institut fur Diagnostik der Epilepsien Gmbh
🇩🇪Berlin, Germany
Klinik Ernst von Bergmann
🇩🇪Potsdam, Germany
Dr. Horst-Schmidt Klinik, Neurologie
🇩🇪Wiesbaden, Germany
St. Josephs Hospital, Neurologische Klinik
🇩🇪Bochum, Germany
Dr. Heinrich C. Braeuer
🇩🇪Hamburg, Germany
Neurologische Klinik der Universitat Erlangen
🇩🇪Erlangen, Germany
Ev. Krankenhaus Alsterdorf, Epilepsiezentrum Alsterdorf
🇩🇪Hamburg, Germany
Universtitatsklinikum Munster, Klinik und Poliklinik fur Neurologie
🇩🇪Munster, Nordrhein-Westphalen, Germany
Charite Campus Virchow-Klinikum, Neurologische Klinik und Poliklinik
🇩🇪Berlin, Germany
Universtitatsklinikum Bonn
🇩🇪Bonn, Nordrhein-Westphalen, Germany
Dr. Gunther Schumann
🇩🇪Bochum, Germany
Knappschaftskrankenhaus Bochum-Langendreer, Neurologische Klinik
🇩🇪Bochum, Germany
Dr. Hans Martin Kolbinger
🇩🇪Bonn, Germany
Epilepsiezentrum Bethel/KSE
🇩🇪Beilefeld, Germany
Klinikum Grosshadern, Neurologische Klinik und Poliklinik, Epilepsie-Ambulanz
🇩🇪Munchen, Germany
Epilepsiezentrum Kleinwachau, Epilepsieambulanz
🇩🇪Liegau-Augustusbad, Germany
Universitatsklinikum Mannheim, Neurologische Klinik, Ambulanz fur Anfallserkrankte
🇩🇪Mannheim, Germany
Klinikum Offenbach, Neurologie
🇩🇪Offenbach, Germany
Epilepsiezentrum Kork
🇩🇪Kehl, Germany
Neuro-Consil Gmbh
🇩🇪Dusseldorf, Germany
Universitatsklinikum, Interdisziplinares Epilepsiezentrum
🇩🇪Marburg, Germany
Universitatsklinik Essen, Klinik und Poliklinik fur Neurologie
🇩🇪Essen, Germany
Universitatsklinikum Freiburg, Neurozentrum
🇩🇪Freiburg, Germany
Universitatsklinikum Gottingen, Abt. fur klinische Neurophysiologie
🇩🇪Gottingen, Germany
Gemeinschaftpraxis fur Neurologie und Psychiatrie
🇩🇪Hamburg, Germany
Klinik "Die Weissenau", Anfallsambulanz
🇩🇪Revensburg, Germany
Universitat Regensburg, Klinik un Poliklinik fur Neurologie
🇩🇪Regensburg, Germany
Universitat Rostock, Klinik fur Neurologie und Poliklinik
🇩🇪Rostock, Germany
Universitatsklinik Ulm Poliklinik fur Neurologie, Epilepsieambulanz
🇩🇪Ulm, Germany