ID

4859

Beskrivning

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

Länk

http://clinicaltrials.gov/show/NCT00165828

Nyckelord

  1. 2011-12-02 2011-12-02 -
  2. 2014-03-25 2014-03-25 - Martin Dugas
  3. 2014-04-13 2014-04-13 - Julian Varghese
  4. 2014-04-13 2014-04-13 - Julian Varghese
Uppladdad den

13 april 2014

DOI

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Licens

Creative Commons BY 4.0

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Eligibility NCT00165828 Epilepsy

Eligibility NCT00165828

  1. StudyEvent: Eligibility
    1. Eligibility NCT00165828
Inclusion Criteria at screening
Beskrivning

Inclusion Criteria at screening

Alias
UMLS CUI-1
C1512693
Adult aged between 18 years and 74 years
Beskrivning

Age

Datatyp

boolean

Focal epileptic seizures with or without secondary generalization
Beskrivning

Focal epileptic seizures

Datatyp

boolean

Alias
UMLS CUI-1
C0014547
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.
Beskrivning

Present treatment with one or two antiepileptic drugs

Datatyp

boolean

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)
Beskrivning

Not pregnant

Datatyp

boolean

Alias
UMLS CUI-1
C0232973
For male patients with partners of childbearing potential: a safe method of contraception is practiced during their study participation
Beskrivning

Contraception

Datatyp

boolean

Alias
UMLS CUI-1
C2348568
Written consent to participate in the study
Beskrivning

Written informed consent

Datatyp

boolean

Alias
UMLS CUI-1
C0021430
Inclusion criteria for randomisation
Beskrivning

Inclusion criteria for randomisation

Alias
UMLS CUI-1
C1512693
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.
Beskrivning

At least 6 focal or clonicotonic seizures

Datatyp

boolean

Alias
UMLS CUI-1
C0036572
Exclusion criteria at screening
Beskrivning

Exclusion criteria at screening

Alias
UMLS CUI-1
C0680251
Epileptic state during the past year
Beskrivning

Status epilepticus

Datatyp

boolean

Alias
UMLS CUI-1
C0038220
Non-epileptic fits
Beskrivning

Non-epileptic fits

Datatyp

boolean

Generalized epilepsy
Beskrivning

Generalized epilepsy

Datatyp

boolean

Alias
UMLS CUI-1
C0014548
More than 4 weeks of seizure freedom during baseline phase
Beskrivning

More than 4 weeks of seizure freedom during baseline phase

Datatyp

boolean

Concomitant progressive CNS disease including progressive myoclonus epilepsy
Beskrivning

Concomitant progressive CNS disease including progressive myoclonus epilepsy

Datatyp

boolean

Concomitant treatment with vigabatrine and / or topiramate
Beskrivning

Concomitant treatment with vigabatrine and / or topiramate

Datatyp

boolean

Hepatic and/or renal insufficiency (creatine > 2mg% or GPT > 2 times ULN)
Beskrivning

Hepatic and/or renal insufficiency

Datatyp

boolean

Alias
UMLS CUI-1
C0201976
UMLS CUI-2
C0201976
Body weight <= 40 kg
Beskrivning

Body weight

Datatyp

boolean

Alias
UMLS CUI-1
C0005910
(History of) kidney stones; erythrocyturia, family history (in parents, children, brothers and sisters or grandparents) of kidney stones
Beskrivning

Kidney stones

Datatyp

boolean

Alias
UMLS CUI-1
C0022650
(History of) drug and/or alcohol dependence
Beskrivning

Drug / alcohol dependence

Datatyp

boolean

Alias
UMLS CUI-1
C1510472
UMLS CUI-2
C0338785
Active psychosis
Beskrivning

Active psychosis

Datatyp

boolean

Alias
UMLS CUI-1
C0033975
Suicide attempt during the past 3 years
Beskrivning

Suicide attempt

Datatyp

boolean

Alias
UMLS CUI-1
C0038663
Pre-treatment with zonisamide
Beskrivning

Pre-treatment with zonisamide

Datatyp

boolean

Known hypersensitivity to sulfonamides
Beskrivning

Hypersensitivity to sulfonamides

Datatyp

boolean

Alias
UMLS CUI-1
C0020517
UMLS CUI-2
C0038760
Concomitant treatment with neuroleptic drugs
Beskrivning

Concomitant treatment with neuroleptic drugs

Datatyp

boolean

Alias
UMLS CUI-1
C1707479
UMLS CUI-2
C0040615
pregnant or breast feeding woman
Beskrivning

pregnant or breast feeding

Datatyp

boolean

Alias
UMLS CUI-1
C0549206
UMLS CUI-2
C0006147
participation in another therapy study within 3 months prior to or during this study
Beskrivning

other trial

Datatyp

boolean

Alias
UMLS CUI-1
C2348568
blood donation planned during or within 4 weeks after the participation in this study
Beskrivning

blood donation

Datatyp

boolean

Alias
UMLS CUI-1
C0005794
elective surgery planned during the participation in this study
Beskrivning

elective surgery

Datatyp

boolean

Alias
UMLS CUI-1
C0206058
patient is not willing or not capable to meet the study demands
Beskrivning

compliance

Datatyp

boolean

Alias
UMLS CUI-1
C1321605
patient does not agree to the forwarding of his/her pseudonymous data
Beskrivning

patient does not agree to forward data

Datatyp

boolean

patient without legal competence
Beskrivning

patient without legal competence

Datatyp

boolean

Exclusion criteria for randomisation
Beskrivning

Exclusion criteria for randomisation

Alias
UMLS CUI-1
C0680251
More than 4 consecutive weeks of freedom from seizure during baseline phase
Beskrivning

freedom from seizure 4+ weeks

Datatyp

boolean

Similar models

Eligibility NCT00165828

  1. StudyEvent: Eligibility
    1. Eligibility NCT00165828
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria at screening
C1512693 (UMLS CUI-1)
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)
Item Group
Exclusion criteria at screening
C0680251 (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)
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)
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)
Concomitant treatment with neuroleptic drugs
Item
Concomitant treatment with neuroleptic drugs
boolean
C1707479 (UMLS CUI-1)
C0040615 (UMLS CUI-2)
pregnant or breast feeding
Item
pregnant or breast feeding woman
boolean
C0549206 (UMLS CUI-1)
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

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