Efficacy and Safety of an Add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization - Full Text View

Purpose

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.

Condition	Intervention	Phase
Epilepsy	Drug: Zonegran	Phase IV

Genetics Home Reference related topics:

pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics:

Epilepsy Seizures

Drug Information available for:

Zonisamide BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

Official Title:	Randomized Trial to Assess Efficacy and Safety of an Add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	May 2005
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: 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.
2: Experimental	Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria at screening:

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

Inclusion criteria for randomisation:

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 at screening:

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

Exclusion criteria for randomisation:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165828

Contacts


Contact: EIsai GmbH Germany	004969665850

Locations


Germany
	Epilepsiezentrum Bethel/KSE	Recruiting
	Beilefeld, Germany, 33617
	Epilepsiezentrum Kork	Recruiting
	Kehl, Germany, 77694
	Charite Campus Virchow-Klinikum, Neurologische Klinik und Poliklinik	Recruiting
	Berlin, Germany, 13353
	Universitat Regensburg, Klinik un Poliklinik fur Neurologie	Recruiting
	Regensburg, Germany, 93053
	Universitatsklinikum Freiburg, Neurozentrum	Recruiting
	Freiburg, Germany, 79106
	Institut fur Diagnostik der Epilepsien Gmbh	Recruiting
	Berlin, Germany, 10362
	Universitatsklinikum Gottingen, Abt. fur klinische Neurophysiologie	Recruiting
	Gottingen, Germany, 37075
	Knappschaftskrankenhaus Bochum-Langendreer, Neurologische Klinik	Recruiting
	Bochum, Germany, 44892
	Ev. Krankenhaus Alsterdorf, Epilepsiezentrum Alsterdorf	Recruiting
	Hamburg, Germany, 22337
	Klinikum Grosshadern, Neurologische Klinik und Poliklinik, Epilepsie-Ambulanz	Recruiting
	Munchen, Germany, 81377
	Dr. Horst-Schmidt Klinik, Neurologie	Recruiting
	Wiesbaden, Germany, 65199
	Universitat Rostock, Klinik fur Neurologie und Poliklinik	Recruiting
	Rostock, Germany, 18147
	Universitatsklinik Essen, Klinik und Poliklinik fur Neurologie	Recruiting
	Essen, Germany, 45147
	Dr. Heinrich C. Braeuer	Recruiting
	Hamburg, Germany, 22299
	Neurologische Klinik der Universitat Erlangen	Recruiting
	Erlangen, Germany, 91054
	Universitatsklinik Ulm Poliklinik fur Neurologie, Epilepsieambulanz	Recruiting
	Ulm, Germany, 89075
	Klinik Ernst von Bergmann	Recruiting
	Potsdam, Germany, 14467
	Universitatsklinikum, Interdisziplinares Epilepsiezentrum	Recruiting
	Marburg, Germany, 35043
	Klinik "Die Weissenau", Anfallsambulanz	Recruiting
	Revensburg, Germany, 88214
	St. Josephs Hospital, Neurologische Klinik	Recruiting
	Bochum, Germany, 44791
	Epilepsiezentrum Kleinwachau, Epilepsieambulanz	Recruiting
	Liegau-Augustusbad, Germany, 01465
	Dr. Gunther Schumann	Recruiting
	Bochum, Germany, 44805
	Universitatsklinikum Mannheim, Neurologische Klinik, Ambulanz fur Anfallserkrankte	Recruiting
	Mannheim, Germany, 68167
	Klinikum Offenbach, Neurologie	Recruiting
	Offenbach, Germany, 63069
	Gemeinschaftpraxis fur Neurologie und Psychiatrie	Recruiting
	Hamburg, Germany, 22083
	Neuro-Consil Gmbh	Recruiting
	Dusseldorf, Germany, 40212
	Dr. Hans Martin Kolbinger	Recruiting
	Bonn, Germany, 53127

Germany, Brandenburg
	Epilepsieklinik Tabor	Recruiting
	Bernau, Brandenburg, Germany, 16321

Germany, Nordrhein-Westphalen
	Universtitatsklinikum Bonn	Recruiting
	Bonn, Nordrhein-Westphalen, Germany, 53105
	Universtitatsklinikum Munster, Klinik und Poliklinik fur Neurologie	Recruiting
	Munster, Nordrhein-Westphalen, Germany, 48129

Sponsors and Collaborators

Eisai GmbH

Investigators


Principal Investigator:	Christian Elger	Universitatsklinikum Bonn, Klinik fur Epileptologie

More Information

Responsible Party:	Eisai GmbH ( Dr. Helga Schmitz, Medical Director )
Study ID Numbers:	ZNS-D-04-001
First Received:	September 13, 2005
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00165828
Health Authority:	Germany: Bundesinstitut fur Arzneimittel und Medizinprodukte, Klinische Prufung

Keywords provided by Eisai Medical Research Inc.:

Epilepsy

Study placed in the following topic categories:

Epilepsy

Zonisamide

Seizures

Neoplasm Metastasis

Central Nervous System Diseases

Brain Diseases

Additional relevant MeSH terms:

Antioxidants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Central Nervous System Agents

Protective Agents

Anticonvulsants

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2008

Sponsored by:	Eisai GmbH
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00165828