ID

24888

Beschrijving

Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00559871

Link

https://clinicaltrials.gov/show/NCT00559871

Trefwoorden

Versies (1)
  1. 22-08-17 22-08-17 -
Geüploaded op

22 augustus 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00559871

Engels

Eligibility Parkinson's Disease NCT00559871

1 Formulieren  
Criteria
Beschrijving

Criteria

idiopathic parkinson's disease.
Beschrijving

Parkinson Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0030567
levodopa/ddi associated peak-dose dyskinesia which is at least moderately disabling and present for ≥25% of the waking day (updrs part iv, items 32 and 33, each ≥ 2).
Beschrijving

Levodopa-induced dyskinesias Dose Peak | DOPA Decarboxylase Inhibitors Associated with Dyskinesia Dose Peak | Disability - moderate Unified Parkinson's Disease Rating Scale Questionnaire

Datatype

boolean

Alias
UMLS CUI [1,1]
C1970038
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0444505
UMLS CUI [2,1]
C0598272
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0013384
UMLS CUI [2,4]
C0178602
UMLS CUI [2,5]
C0444505
UMLS CUI [3,1]
C0424989
UMLS CUI [3,2]
C3639721
stable parkinson's medication for at least 1 month prior to randomization.
Beschrijving

Antiparkinson Agents Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0205360
hoehn and yahr stages 1 to 4 during 'off' period.
Beschrijving

Hoehn and Yahr grades

Datatype

boolean

Alias
UMLS CUI [1]
C0451215
demonstrated ability to comprehend and give informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
ability to complete patient diary.
Beschrijving

Subject Diary Complete Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0600109
main exclusion criteria:
Beschrijving

Exclusion Criteria Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
other clinically significant conditions apart from those typically associated with parkinson's disease.
Beschrijving

Condition Clinical Significance | Exception Condition Associated with Parkinson Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C0030567
intake of medication associated with exacerbation of dyskinesia or with extrapyramidal side effects and tardive dyskinesia or induction of liver enzymes; neuroleptics; or specified drugs known to be substantially metabolized through the following cytochrome p450 isoenzymes: 1a2, 2b6, 2c19, 2c9, 2d6, and 2e1.
Beschrijving

Pharmaceutical Preparations Associated with Exacerbation Dyskinesia | Drug-induced extrapyramidal side effects | Pharmaceutical Preparations Associated with Tardive Dyskinesia | Pharmaceutical Preparations Associated with Induction Liver enzyme | Antipsychotic Agents | Pharmaceutical Preparations Metabolized CYP1A2 | Pharmaceutical Preparations Metabolized CYP2B6 | Pharmaceutical Preparations Metabolized CYP2C19 | Pharmaceutical Preparations Metabolized CYP2C9 | Pharmaceutical Preparations Metabolized CYP2D6 | Pharmaceutical Preparations Metabolized CYP2E1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C4086268
UMLS CUI [1,4]
C0013384
UMLS CUI [2]
C0858266
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0686347
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0205263
UMLS CUI [4,4]
C0443764
UMLS CUI [5]
C0040615
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C1524026
UMLS CUI [6,3]
C0207509
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C1524026
UMLS CUI [7,3]
C1828468
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C1524026
UMLS CUI [8,3]
C0960580
UMLS CUI [9,1]
C0013227
UMLS CUI [9,2]
C1524026
UMLS CUI [9,3]
C0608437
UMLS CUI [10,1]
C0013227
UMLS CUI [10,2]
C1524026
UMLS CUI [10,3]
C0057223
UMLS CUI [11,1]
C0013227
UMLS CUI [11,2]
C1524026
UMLS CUI [11,3]
C0010763
use of st. john's wort or ginkgo biloba within 48 hrs prior to randomization and until the last treatment day with the study medication.
Beschrijving

St. john's wort | Ginkgo biloba

Datatype

boolean

Alias
UMLS CUI [1]
C0936242
UMLS CUI [2]
C0772125
intake of an investigational drug within 30 days prior to initial screening.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Parkinson's Disease NCT00559871

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Parkinson Disease
Item
idiopathic parkinson's disease.
boolean
C0030567 (UMLS CUI [1])
Levodopa-induced dyskinesias Dose Peak | DOPA Decarboxylase Inhibitors Associated with Dyskinesia Dose Peak | Disability - moderate Unified Parkinson's Disease Rating Scale Questionnaire
Item
levodopa/ddi associated peak-dose dyskinesia which is at least moderately disabling and present for ≥25% of the waking day (updrs part iv, items 32 and 33, each ≥ 2).
boolean
C1970038 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0444505 (UMLS CUI [1,3])
C0598272 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0013384 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])
C0444505 (UMLS CUI [2,5])
C0424989 (UMLS CUI [3,1])
C3639721 (UMLS CUI [3,2])
Antiparkinson Agents Stable
Item
stable parkinson's medication for at least 1 month prior to randomization.
boolean
C0003405 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Hoehn and Yahr grades
Item
hoehn and yahr stages 1 to 4 during 'off' period.
boolean
C0451215 (UMLS CUI [1])
Informed Consent
Item
demonstrated ability to comprehend and give informed consent.
boolean
C0021430 (UMLS CUI [1])
Subject Diary Complete Willing
Item
ability to complete patient diary.
boolean
C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Condition Clinical Significance | Exception Condition Associated with Parkinson Disease
Item
other clinically significant conditions apart from those typically associated with parkinson's disease.
boolean
C0348080 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0030567 (UMLS CUI [2,4])
Pharmaceutical Preparations Associated with Exacerbation Dyskinesia | Drug-induced extrapyramidal side effects | Pharmaceutical Preparations Associated with Tardive Dyskinesia | Pharmaceutical Preparations Associated with Induction Liver enzyme | Antipsychotic Agents | Pharmaceutical Preparations Metabolized CYP1A2 | Pharmaceutical Preparations Metabolized CYP2B6 | Pharmaceutical Preparations Metabolized CYP2C19 | Pharmaceutical Preparations Metabolized CYP2C9 | Pharmaceutical Preparations Metabolized CYP2D6 | Pharmaceutical Preparations Metabolized CYP2E1
Item
intake of medication associated with exacerbation of dyskinesia or with extrapyramidal side effects and tardive dyskinesia or induction of liver enzymes; neuroleptics; or specified drugs known to be substantially metabolized through the following cytochrome p450 isoenzymes: 1a2, 2b6, 2c19, 2c9, 2d6, and 2e1.
boolean
C0013227 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
C0013384 (UMLS CUI [1,4])
C0858266 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0686347 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0205263 (UMLS CUI [4,3])
C0443764 (UMLS CUI [4,4])
C0040615 (UMLS CUI [5])
C0013227 (UMLS CUI [6,1])
C1524026 (UMLS CUI [6,2])
C0207509 (UMLS CUI [6,3])
C0013227 (UMLS CUI [7,1])
C1524026 (UMLS CUI [7,2])
C1828468 (UMLS CUI [7,3])
C0013227 (UMLS CUI [8,1])
C1524026 (UMLS CUI [8,2])
C0960580 (UMLS CUI [8,3])
C0013227 (UMLS CUI [9,1])
C1524026 (UMLS CUI [9,2])
C0608437 (UMLS CUI [9,3])
C0013227 (UMLS CUI [10,1])
C1524026 (UMLS CUI [10,2])
C0057223 (UMLS CUI [10,3])
C0013227 (UMLS CUI [11,1])
C1524026 (UMLS CUI [11,2])
C0010763 (UMLS CUI [11,3])
St. john's wort | Ginkgo biloba
Item
use of st. john's wort or ginkgo biloba within 48 hrs prior to randomization and until the last treatment day with the study medication.
boolean
C0936242 (UMLS CUI [1])
C0772125 (UMLS CUI [2])
Investigational New Drugs
Item
intake of an investigational drug within 30 days prior to initial screening.
boolean
C0013230 (UMLS CUI [1])
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