Clinical trial NCT00165828: Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Epilepsy
Keywords: Epilepsy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in number of epileptic seizures between week 13 and 16 after start of treatment compared to the correspondently normalized base-line phase.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bernau
country: Germany
facility: Epilepsieklinik Tabor
state: Brandenburg
city: Bonn
country: Germany
facility: Universtitatsklinikum Bonn
state: Nordrhein-Westphalen
city: Munster
country: Germany
facility: Universtitatsklinikum Munster, Klinik und Poliklinik fur Neurologie
state: Nordrhein-Westphalen
city: Beilefeld
country: Germany
facility: Epilepsiezentrum Bethel/KSE
city: Berlin
country: Germany
facility: Institut fur Diagnostik der Epilepsien Gmbh
city: Berlin
country: Germany
facility: Charite Campus Virchow-Klinikum, Neurologische Klinik und Poliklinik
city: Bochum
country: Germany
facility: St. Josephs Hospital, Neurologische Klinik
city: Bochum
country: Germany
facility: Dr. Gunther Schumann
city: Bochum
country: Germany
facility: Knappschaftskrankenhaus Bochum-Langendreer, Neurologische Klinik
city: Bonn
country: Germany
facility: Dr. Hans Martin Kolbinger
city: Dusseldorf
country: Germany
facility: Neuro-Consil Gmbh
city: Erlangen
country: Germany
facility: Neurologische Klinik der Universitat Erlangen
city: Essen
country: Germany
facility: Universitatsklinik Essen, Klinik und Poliklinik fur Neurologie
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg, Neurozentrum
city: Gottingen
country: Germany
facility: Universitatsklinikum Gottingen, Abt. fur klinische Neurophysiologie
city: Hamburg
country: Germany
facility: Gemeinschaftpraxis fur Neurologie und Psychiatrie
city: Hamburg
country: Germany
facility: Dr. Heinrich C. Braeuer
city: Hamburg
country: Germany
facility: Ev. Krankenhaus Alsterdorf, Epilepsiezentrum Alsterdorf
city: Kehl
country: Germany
facility: Epilepsiezentrum Kork
city: Liegau-Augustusbad
country: Germany
facility: Epilepsiezentrum Kleinwachau, Epilepsieambulanz
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim, Neurologische Klinik, Ambulanz fur Anfallserkrankte
city: Marburg
country: Germany
facility: Universitatsklinikum, Interdisziplinares Epilepsiezentrum
city: Munchen
country: Germany
facility: Klinikum Grosshadern, Neurologische Klinik und Poliklinik, Epilepsie-Ambulanz
city: Offenbach
country: Germany
facility: Klinikum Offenbach, Neurologie
city: Potsdam
country: Germany
facility: Klinik Ernst von Bergmann
city: Regensburg
country: Germany
facility: Universitat Regensburg, Klinik un Poliklinik fur Neurologie
city: Revensburg
country: Germany
facility: Klinik "Die Weissenau", Anfallsambulanz
city: Rostock
country: Germany
facility: Universitat Rostock, Klinik fur Neurologie und Poliklinik
city: Ulm
country: Germany
facility: Universitatsklinik Ulm Poliklinik fur Neurologie, Epilepsieambulanz
city: Wiesbaden
country: Germany
facility: Dr. Horst-Schmidt Klinik, Neurologie
Study officials:
affiliation: Universitatsklinikum Bonn, Klinik fur Epileptologie
name: Christian Elger
role: PRINCIPAL_INVESTIGATOR
References: