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

NCT ID: NCT00165828

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2008-02-29

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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Zonegran

Intervention Type: DRUG

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.

2

Group Type: EXPERIMENTAL

Zonegran

Intervention Type: DRUG

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.

Interventions

Zonegran

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult aged between 18 years and 74 years
• Focal epileptic seizures with or without secondary generalization
• Present treatment with one or two antiepileptic drugs (constant dosage during 8 weeks baseline phase prior to initiation of treatment with zonisamide). Stimulation of the vagus nerve is permitted and will not be counted as antiepileptic drug.
• For women of childbearing potential (postmenopausal for more than 1 year): possible pregnancy during the study can be excluded (by hysterectomy, sterilization or simultaneous application of two recognized methods of contraception (no oral contraceptives only)
• For male patients with partners of childbearing potential: a safe method of contraception is practiced during their study participation
• Written consent to participate in the study

• At least 6 focal or clonicotonic seizures documented completely in a seizure diary or the patient chart during the 8 prospective or retrospective weeks baseline phase.

Exclusion Criteria

• Epileptic state during the past year
• Non-epileptic fits
• Generalized epilepsy
• More than 4 weeks of seizure freedom during baseline phase
• Concomitant progressive CNS disease including progressive myoclonus epilepsy
• Concomitant treatment with vigabatrine and / or topiramate
• Hepatic and/or renal insufficiency (creatine > 2mg% or GPT > 2 times ULN)
• Body weight ≤ 40 kg
• (History of) kidney stones; erythrocyturia, family history (in parents, children, brothers and sisters or grandparents) of kidney stones
• (History of) drug and/or alcohol dependence
• Active psychosis
• Suicide attempt during the past 3 years
• Pre-treatment with zonisamide
• Known hypersensitivity to sulfonamides
• concomitant treatment with neuroleptic drugs
• pregnant or breast feeding woman
• participation in another therapy study within 3 months prior to or during this study
• blood donation planned during or within 4 weeks after the participation in this study
• elective surgery planned during the participation in this study
• patient is not willing or not capable to meet the study demands
• patient does not agree to the forwarding of his/her pseudonymous data
• patient without legal competence

• More than 4 consecutive weeks of freedom from seizure during baseline phase

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Elger

Role: PRINCIPAL_INVESTIGATOR

Universitatsklinikum Bonn, Klinik fur Epileptologie

Locations

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

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

Neuro-Consil Gmbh

Düsseldorf, , Germany

Neurologische Klinik der Universitat Erlangen

Erlangen, , Germany

Universitatsklinik Essen, Klinik und Poliklinik fur Neurologie

Essen, , Germany

Universitatsklinikum Freiburg, Neurozentrum

Freiburg im Breisgau, , Germany

Universitatsklinikum Gottingen, Abt. fur klinische Neurophysiologie

Göttingen, , Germany

Gemeinschaftpraxis fur Neurologie und Psychiatrie

Hamburg, , Germany

Dr. Heinrich C. Braeuer

Hamburg, , Germany

Ev. Krankenhaus Alsterdorf, Epilepsiezentrum Alsterdorf

Hamburg, , Germany

Epilepsiezentrum Kork

Kehl, , Germany

Epilepsiezentrum Kleinwachau, Epilepsieambulanz

Liegau-Augustusbad, , Germany

Universitatsklinikum Mannheim, Neurologische Klinik, Ambulanz fur Anfallserkrankte

Mannheim, , Germany

Universitatsklinikum, Interdisziplinares Epilepsiezentrum

Marburg, , Germany

Klinikum Grosshadern, Neurologische Klinik und Poliklinik, Epilepsie-Ambulanz

München, , Germany

Klinikum Offenbach, Neurologie

Offenbach, , Germany

Klinik Ernst von Bergmann

Potsdam, , Germany

Universitat Regensburg, Klinik un Poliklinik fur Neurologie

Regensburg, , Germany

Klinik "Die Weissenau", Anfallsambulanz

Revensburg, , Germany

Universitat Rostock, Klinik fur Neurologie und Poliklinik

Rostock, , Germany

Universitatsklinik Ulm Poliklinik fur Neurologie, Epilepsieambulanz

Ulm, , Germany

Dr. Horst-Schmidt Klinik, Neurologie

Wiesbaden, , Germany

Countries

Germany

Other Identifiers

2005-000260-57

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ZNS-D-04-001

Identifier Type: -

Identifier Source: org_study_id