Age
Item
Adult aged between 18 years and 74 years
boolean
Focal epileptic seizures
Item
Focal epileptic seizures with or without secondary generalization
boolean
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 and contraception
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
contraception
Item
For male patients with partners of childbearing potential: a safe method of contraception is practiced during their study participation
boolean
consent
Item
Written consent to participate in the study
boolean
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
Epileptic state during the past year
Item
Epileptic state during the past year
boolean
Non-epileptic fits
Item
Non-epileptic fits
boolean
Generalized epilepsy
Item
Generalized epilepsy
boolean
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
Body weight <= 40 kg
Item
Body weight <= 40 kg
boolean
Kidney stones
Item
(History of) kidney stones; erythrocyturia, family history (in parents, children, brothers and sisters or grandparents) of kidney stones
boolean
drug or alcohol dependence
Item
(History of) drug and/or alcohol dependence
boolean
Active psychosis
Item
Active psychosis
boolean
Suicide attempt during the past 3 years
Item
Suicide attempt during the past 3 years
boolean
Pre-treatment with zonisamide
Item
Pre-treatment with zonisamide
boolean
Known hypersensitivity to sulfonamides
Item
Known hypersensitivity to sulfonamides
boolean
concomitant treatment with neuroleptic drugs
Item
concomitant treatment with neuroleptic drugs
boolean
pregnant or breast feeding woman
Item
pregnant or breast feeding woman
boolean
other study
Item
participation in another therapy study within 3 months prior to or during this study
boolean
blood donation
Item
blood donation planned during or within 4 weeks after the participation in this study
boolean
elective surgery planned
Item
elective surgery planned during the participation in this study
boolean
patient is not willing or not capable to meet the study demands
Item
patient is not willing or not capable to meet the study demands
boolean
patient does not agree to the forwarding of his/her pseudonymous 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
More than 4 consecutive weeks of freedom from seizure during baseline phase
Item
More than 4 consecutive weeks of freedom from seizure during baseline phase
boolean
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Epilepsy
Item
Epilepsia
string
C0014544 (UMLS CUI)
84757009 (SNOMED CT 2010_0731)
10015037 (MedDRA 13.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
Epilepsies, Partial
Item
Focal epilepsy
string
C0014547 (UMLS CUI)
230381009 (SNOMED CT 2010_0731)
10065337 (MedDRA 13.1)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Antiepileptic Agents
Item
Anticonvulsant
string
C0003299 (UMLS CUI)
255632006 (SNOMED CT 2010_0731)
MTHU006781 (LOINC Version 232)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Seizures
Item
Convulsion
string
C0036572 (UMLS CUI)
91175000 (SNOMED CT 2010_0731)
10039910 (MedDRA 13.1)
780.39 (ICD-9-CM Version 2011)
Status Epilepticus
Item
Epileptic state
string
C0038220 (UMLS CUI)
230456007 (SNOMED CT 2010_0731)
10041962 (MedDRA 13.1)
G41 (ICD-10-CM Version 2010)
Epilepsy, Generalized
Item
Generalized epilepsy
string
C0014548 (UMLS CUI)
19598007 (SNOMED CT 2010_0731)
Creatinine
Item
Creatinine
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
10011358 (MedDRA 13.1)
38483-4 (LOINC Version 232)
ALT
Item
GPT (Serum)
string
C0001899 (UMLS CUI)
56935002 (SNOMED CT 2010_0731)
10001844 (MedDRA 13.1)
Weight
Item
Weight
string
C1305866 (UMLS CUI)
107647005 (SNOMED CT 2010_0731)
10047890 (MedDRA 13.1)
LP18015-5 (LOINC Version 232)
Kidney Calculi
Item
Kidney stones
string
C0022650 (UMLS CUI)
95570007 (SNOMED CT 2010_0731)
10023436 (MedDRA 13.1)
N20.0 (ICD-10-CM Version 2010)
592.0 (ICD-9-CM Version 2011)
E13018 (CTCAE Version 4.03)
Alcohol abuse
Item
Alcohol abuse
string
C0085762 (UMLS CUI)
15167005 (SNOMED CT 2010_0731)
10001584 (MedDRA 13.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Psychotic Disorders
Item
Psychosis (Psychotic disorder)
string
C0033975 (UMLS CUI)
69322001 (SNOMED CT 2010_0731)
10061920 (MedDRA 13.1)
290-299.99 (ICD-9-CM Version 2011)
E12954 (CTCAE Version 4.03)
Suicide attempt
Item
Attempted Suicide
string
C0038663 (UMLS CUI)
82313006 (SNOMED CT 2010_0731)
10042464 (MedDRA 13.1)
T14.91 (ICD-10-CM Version 2010)
E12969 (CTCAE Version 4.03)
Allergy
Item
Hypersensitivity
string
C0020517 (UMLS CUI)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
Sulfonamides
Item
Sulfonamide
string
C0038760 (UMLS CUI)
387406002 (SNOMED CT 2010_0731)
MTHU007722 (LOINC Version 232)
Antipsychotic Agent
Item
Neuroleptic drug
string
C0040615 (UMLS CUI)
10784006 (SNOMED CT 2010_0731)
MTHU003337 (LOINC Version 232)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
Elective Surgical Procedure
Item
Optional surgery
string
C0206058 (UMLS CUI)
274075007 (SNOMED CT 2010_0731)
10058829 (MedDRA 13.1)
Compliance
Item
Compliance
string
C1321605 (UMLS CUI)
405078008 (SNOMED CT 2010_0731)