Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization
Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: Zonegran (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Eisai GmbH Official(s) and/or principal investigator(s): Christian Elger, Principal Investigator, Affiliation: Universitatsklinikum Bonn, Klinik fur Epileptologie
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in number of epileptic seizures between week 13 and 16 after start of treatment compared to the correspondently normalized base-line phase.
Eligibility
Minimum age: 18 Years.
Maximum age: 74 Years.
Gender(s): Both.
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
Locations and Contacts
Epilepsiezentrum Bethel/KSE, Beilefeld 33617, Germany
Charite Campus Virchow-Klinikum, Neurologische Klinik und Poliklinik, Berlin 13353, Germany
Institut fur Diagnostik der Epilepsien Gmbh, Berlin 10362, Germany
Dr. Gunther Schumann, Bochum 44805, Germany
Knappschaftskrankenhaus Bochum-Langendreer, Neurologische Klinik, Bochum 44892, Germany
St. Josephs Hospital, Neurologische Klinik, Bochum 44791, Germany
Dr. Hans Martin Kolbinger, Bonn 53127, Germany
Neuro-Consil Gmbh, Dusseldorf 40212, Germany
Neurologische Klinik der Universitat Erlangen, Erlangen 91054, Germany
Universitatsklinik Essen, Klinik und Poliklinik fur Neurologie, Essen 45147, Germany
Universitatsklinikum Freiburg, Neurozentrum, Freiburg 79106, Germany
Universitatsklinikum Gottingen, Abt. fur klinische Neurophysiologie, Gottingen 37075, Germany
Dr. Heinrich C. Braeuer, Hamburg 22299, Germany
Ev. Krankenhaus Alsterdorf, Epilepsiezentrum Alsterdorf, Hamburg 22337, Germany
Gemeinschaftpraxis fur Neurologie und Psychiatrie, Hamburg 22083, Germany
Epilepsiezentrum Kork, Kehl 77694, Germany
Epilepsiezentrum Kleinwachau, Epilepsieambulanz, Liegau-Augustusbad 01465, Germany
Universitatsklinikum Mannheim, Neurologische Klinik, Ambulanz fur Anfallserkrankte, Mannheim 68167, Germany
Universitatsklinikum, Interdisziplinares Epilepsiezentrum, Marburg 35043, Germany
Klinikum Grosshadern, Neurologische Klinik und Poliklinik, Epilepsie-Ambulanz, Munchen 81377, Germany
Klinikum Offenbach, Neurologie, Offenbach 63069, Germany
Klinik Ernst von Bergmann, Potsdam 14467, Germany
Universitat Regensburg, Klinik un Poliklinik fur Neurologie, Regensburg 93053, Germany
Klinik "Die Weissenau", Anfallsambulanz, Revensburg 88214, Germany
Universitat Rostock, Klinik fur Neurologie und Poliklinik, Rostock 18147, Germany
Universitatsklinik Ulm Poliklinik fur Neurologie, Epilepsieambulanz, Ulm 89075, Germany
Dr. Horst-Schmidt Klinik, Neurologie, Wiesbaden 65199, Germany
Epilepsieklinik Tabor, Bernau, Brandenburg 16321, Germany
Universtitatsklinikum Bonn, Bonn, Nordrhein-Westphalen 53105, Germany
Universtitatsklinikum Munster, Klinik und Poliklinik fur Neurologie, Munster, Nordrhein-Westphalen 48129, Germany
Additional Information
Starting date: May 2005
Last updated: June 26, 2014
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