Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization
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
2 other identifiers
interventional
157
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2005
Typical duration for phase_4
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedJune 27, 2014
November 1, 2013
2.8 years
September 13, 2005
June 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai GmbHlead
Study Sites (30)
Epilepsieklinik Tabor
Bernau bei Berlin, Brandenburg, 16321, Germany
Universtitatsklinikum Bonn
Bonn, Nordrhein-Westphalen, 53105, Germany
Universtitatsklinikum Munster, Klinik und Poliklinik fur Neurologie
Münster, Nordrhein-Westphalen, 48129, Germany
Epilepsiezentrum Bethel/KSE
Beilefeld, 33617, Germany
Institut fur Diagnostik der Epilepsien Gmbh
Berlin, 10362, Germany
Charite Campus Virchow-Klinikum, Neurologische Klinik und Poliklinik
Berlin, 13353, Germany
St. Josephs Hospital, Neurologische Klinik
Bochum, 44791, Germany
Dr. Gunther Schumann
Bochum, 44805, Germany
Knappschaftskrankenhaus Bochum-Langendreer, Neurologische Klinik
Bochum, 44892, Germany
Dr. Hans Martin Kolbinger
Bonn, 53127, Germany
Neuro-Consil Gmbh
Düsseldorf, 40212, Germany
Neurologische Klinik der Universitat Erlangen
Erlangen, 91054, Germany
Universitatsklinik Essen, Klinik und Poliklinik fur Neurologie
Essen, 45147, Germany
Universitatsklinikum Freiburg, Neurozentrum
Freiburg im Breisgau, 79106, Germany
Universitatsklinikum Gottingen, Abt. fur klinische Neurophysiologie
Göttingen, 37075, Germany
Gemeinschaftpraxis fur Neurologie und Psychiatrie
Hamburg, 22083, Germany
Dr. Heinrich C. Braeuer
Hamburg, 22299, Germany
Ev. Krankenhaus Alsterdorf, Epilepsiezentrum Alsterdorf
Hamburg, 22337, 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
München, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Elger
Universitatsklinikum Bonn, Klinik fur Epileptologie
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 14, 2005
Study Start
May 1, 2005
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
June 27, 2014
Record last verified: 2013-11