Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization

Phase 4

Terminated

• Conditions: Epilepsy
• Interventions: Drug: Zonegran

• 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

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-14
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2013-11
• Last Update Submitted: 2014-06-26
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

Not provided

Exclusion Criteria

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

Trial Locations

Locations (30)

Epilepsieklinik Tabor; 🇩🇪 Bernau, Brandenburg, Germany

Universtitatsklinikum Bonn; 🇩🇪 Bonn, Nordrhein-Westphalen, Germany

Universtitatsklinikum Munster, Klinik und Poliklinik fur Neurologie; 🇩🇪 Munster, Nordrhein-Westphalen, Germany

Epilepsiezentrum Bethel/KSE; 🇩🇪 Beilefeld, Germany

Institut fur Diagnostik der Epilepsien Gmbh; 🇩🇪 Berlin, Germany

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

Scroll for more (20 remaining)