Description:

Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization see http://clinicaltrials.gov/show/NCT00165828

Link:

http://clinicaltrials.gov/show/NCT00165828

Keywords:
Versions (4) ▾
  1. 12/2/11
  2. 3/25/14
  3. 4/13/14
  4. 4/13/14
Uploaded on:

April 13, 2014

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License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00165828 Epilepsy

Eligibility NCT00165828

  1. StudyEvent: Eligibility
    1. Eligibility NCT00165828
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