Status:
TERMINATED
Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization
Lead Sponsor:
Eisai GmbH
Conditions:
Epilepsy
Eligibility:
All Genders
18-74 years
Phase:
PHASE4
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 inclusi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00165828
Start Date
May 1 2005
End Date
February 1 2008
Last Update
June 27 2014
Active Locations (30)
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1
Epilepsieklinik Tabor
Bernau bei Berlin, Brandenburg, Germany, 16321
2
Universtitatsklinikum Bonn
Bonn, Nordrhein-Westphalen, Germany, 53105
3
Universtitatsklinikum Munster, Klinik und Poliklinik fur Neurologie
Münster, Nordrhein-Westphalen, Germany, 48129
4
Epilepsiezentrum Bethel/KSE
Beilefeld, Germany, 33617