Informações:
Falhas:
ID
4859
Descrição
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
Palavras-chave
Versões (4)
- 02/12/2011 02/12/2011 -
- 25/03/2014 25/03/2014 - Martin Dugas
- 13/04/2014 13/04/2014 - Julian Varghese
- 13/04/2014 13/04/2014 - Julian Varghese
Transferido a
13 de abril de 2014
DOI
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Licença
Creative Commons BY 4.0
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Eligibility NCT00165828 Epilepsy
Eligibility NCT00165828
- StudyEvent: Eligibility
Similar models
Eligibility NCT00165828
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
Adult aged between 18 years and 74 years
boolean
Focal epileptic seizures
Item
Focal epileptic seizures with or without secondary generalization
boolean
C0014547 (UMLS CUI-1)
Present treatment with one or two antiepileptic drugs
Item
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.
boolean
Not pregnant
Item
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)
boolean
C0232973 (UMLS CUI-1)
Contraception
Item
For male patients with partners of childbearing potential: a safe method of contraception is practiced during their study participation
boolean
C2348568 (UMLS CUI-1)
Written informed consent
Item
Written consent to participate in the study
boolean
C0021430 (UMLS CUI-1)
Item Group
Inclusion criteria for randomisation
C1512693 (UMLS CUI-1)
At least 6 focal or clonicotonic seizures
Item
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.
boolean
C0036572 (UMLS CUI-1)
Status epilepticus
Item
Epileptic state during the past year
boolean
C0038220 (UMLS CUI-1)
Non-epileptic fits
Item
Non-epileptic fits
boolean
Generalized epilepsy
Item
Generalized epilepsy
boolean
C0014548 (UMLS CUI-1)
More than 4 weeks of seizure freedom during baseline phase
Item
More than 4 weeks of seizure freedom during baseline phase
boolean
Concomitant progressive CNS disease including progressive myoclonus epilepsy
Item
Concomitant progressive CNS disease including progressive myoclonus epilepsy
boolean
Concomitant treatment with vigabatrine and / or topiramate
Item
Concomitant treatment with vigabatrine and / or topiramate
boolean
Hepatic and/or renal insufficiency
Item
Hepatic and/or renal insufficiency (creatine > 2mg% or GPT > 2 times ULN)
boolean
C0201976 (UMLS CUI-1)
C0201976 (UMLS CUI-2)
C0201976 (UMLS CUI-2)
Body weight
Item
Body weight <= 40 kg
boolean
C0005910 (UMLS CUI-1)
Kidney stones
Item
(History of) kidney stones; erythrocyturia, family history (in parents, children, brothers and sisters or grandparents) of kidney stones
boolean
C0022650 (UMLS CUI-1)
Drug / alcohol dependence
Item
(History of) drug and/or alcohol dependence
boolean
C1510472 (UMLS CUI-1)
C0338785 (UMLS CUI-2)
C0338785 (UMLS CUI-2)
Active psychosis
Item
Active psychosis
boolean
C0033975 (UMLS CUI-1)
Suicide attempt
Item
Suicide attempt during the past 3 years
boolean
C0038663 (UMLS CUI-1)
Pre-treatment with zonisamide
Item
Pre-treatment with zonisamide
boolean
Hypersensitivity to sulfonamides
Item
Known hypersensitivity to sulfonamides
boolean
C0020517 (UMLS CUI-1)
C0038760 (UMLS CUI-2)
C0038760 (UMLS CUI-2)
Concomitant treatment with neuroleptic drugs
Item
Concomitant treatment with neuroleptic drugs
boolean
C1707479 (UMLS CUI-1)
C0040615 (UMLS CUI-2)
C0040615 (UMLS CUI-2)
pregnant or breast feeding
Item
pregnant or breast feeding woman
boolean
C0549206 (UMLS CUI-1)
C0006147 (UMLS CUI-2)
C0006147 (UMLS CUI-2)
other trial
Item
participation in another therapy study within 3 months prior to or during this study
boolean
C2348568 (UMLS CUI-1)
blood donation
Item
blood donation planned during or within 4 weeks after the participation in this study
boolean
C0005794 (UMLS CUI-1)
elective surgery
Item
elective surgery planned during the participation in this study
boolean
C0206058 (UMLS CUI-1)
compliance
Item
patient is not willing or not capable to meet the study demands
boolean
C1321605 (UMLS CUI-1)
patient does not agree to forward data
Item
patient does not agree to the forwarding of his/her pseudonymous data
boolean
patient without legal competence
Item
patient without legal competence
boolean
Item Group
Exclusion criteria for randomisation
C0680251 (UMLS CUI-1)
freedom from seizure 4+ weeks
Item
More than 4 consecutive weeks of freedom from seizure during baseline phase
boolean