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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00165828
Other study ID # ZNS-D-04-001
Secondary ID 2005-000260-57
Status Terminated
Phase Phase 4
First received September 13, 2005
Last updated June 26, 2014
Start date May 2005
Est. completion date February 2008

Study information

Verified date November 2013
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority Germany: Bundesinstitut fur Arzneimittel und Medizinprodukte, Klinische Prufung
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 157
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 74 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany Epilepsiezentrum Bethel/KSE Beilefeld
Germany Charite Campus Virchow-Klinikum, Neurologische Klinik und Poliklinik Berlin
Germany Institut fur Diagnostik der Epilepsien Gmbh Berlin
Germany Epilepsieklinik Tabor Bernau Brandenburg
Germany Dr. Gunther Schumann Bochum
Germany Knappschaftskrankenhaus Bochum-Langendreer, Neurologische Klinik Bochum
Germany St. Josephs Hospital, Neurologische Klinik Bochum
Germany Dr. Hans Martin Kolbinger Bonn
Germany Universtitatsklinikum Bonn Bonn Nordrhein-Westphalen
Germany Neuro-Consil Gmbh Dusseldorf
Germany Neurologische Klinik der Universitat Erlangen Erlangen
Germany Universitatsklinik Essen, Klinik und Poliklinik fur Neurologie Essen
Germany Universitatsklinikum Freiburg, Neurozentrum Freiburg
Germany Universitatsklinikum Gottingen, Abt. fur klinische Neurophysiologie Gottingen
Germany Dr. Heinrich C. Braeuer Hamburg
Germany Ev. Krankenhaus Alsterdorf, Epilepsiezentrum Alsterdorf Hamburg
Germany Gemeinschaftpraxis fur Neurologie und Psychiatrie 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 Munchen
Germany Universtitatsklinikum Munster, Klinik und Poliklinik fur Neurologie Munster Nordrhein-Westphalen
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

Sponsors (1)

Lead Sponsor Collaborator
Eisai GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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