ID

22392

Description

Study to Evaluate Initiation of Stalevo in Early Wearing-off; ODM derived from: https://clinicaltrials.gov/show/NCT00462007

Link

https://clinicaltrials.gov/show/NCT00462007

Keywords

Versions (1)
  1. 6/1/17 6/1/17 -
Uploaded on

June 1, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00462007

English

Eligibility Parkinson's Disease NCT00462007

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with idiopathic parkinson's disease and early wearing-off symptoms treated with standard levodopa/ddci treatment
Description

Parkinson Disease | Levodopa | DOPA Decarboxylase Inhibitors | Wearing off effect Early

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0023570
UMLS CUI [3]
C0598272
UMLS CUI [4,1]
C1504539
UMLS CUI [4,2]
C1279919
age >35 - years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hoehn and yahr stage 1-3 performed during the 'on'-stage
Description

Hoehn and Yahr Stage | Pharmaceutical Preparations Use of

Data type

boolean

Alias
UMLS CUI [1]
C3639483
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1524063
at least 1 symptom identified by woq-9
Description

Symptoms Quantity Identified Wearing off Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205396
UMLS CUI [1,4]
C1504539
UMLS CUI [1,5]
C0034394
dosing frequency of 3-4 doses of standard-release levodopa/ddci (maximum total daily dose of 600 mg of levodopa)
Description

Levodopa Dose U/day Maximum | DOPA Decarboxylase Inhibitors Dose Frequency

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
UMLS CUI [1,4]
C0806909
UMLS CUI [2,1]
C0598272
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0439603
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
atypical or symptomatic parkinson's disease
Description

Atypical Parkinson Disease | Secondary Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C1868596
UMLS CUI [2]
C0030569
unpredictable off-periods
Description

UPDRS - Off Periods Unpredictable

Data type

boolean

Alias
UMLS CUI [1]
C3639872
any peak-dose dyskinesia. 'off'-state dystonia is allowed
Description

Dyskinetic syndrome Peak Dose | Dystonia Pharmaceutical Preparations Off

Data type

boolean

Alias
UMLS CUI [1,1]
C0013384
UMLS CUI [1,2]
C0444505
UMLS CUI [1,3]
C0178602
UMLS CUI [2,1]
C0013421
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1518543
use of any rescue medications to treat symptoms of 'off'-state. 1 dose of soluble levodopa/ddci is allowed.
Description

Pharmaceutical Preparations Additional | Levodopa Dose Quantity | DOPA Decarboxylase Inhibitors Dose Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0598272
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C1265611
concomitant treatment with non-selective monoamine oxidase (mao) inhibitor or simultaneous use of higher than recommended doses of mao-a and mao-b inhibitors (selegiline 10 mg or rasagiline 1 mg allowed) or use of apomorphine.
Description

Monoamine oxidase inhibitors, non-selective | Monoamine Oxidase-A Inhibitors High dose | Monoamine Oxidase-B Inhibitors High dose | Selegiline Dose | Rasagiline Dose | Apomorphine

Data type

boolean

Alias
UMLS CUI [1]
C3653330
UMLS CUI [2,1]
C2917289
UMLS CUI [2,2]
C0444956
UMLS CUI [3,1]
C2917290
UMLS CUI [3,2]
C0444956
UMLS CUI [4,1]
C0036579
UMLS CUI [4,2]
C0178602
UMLS CUI [5,1]
C0525678
UMLS CUI [5,2]
C0178602
UMLS CUI [6]
C0003596
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Similar models

Eligibility Parkinson's Disease NCT00462007

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Levodopa | DOPA Decarboxylase Inhibitors | Wearing off effect Early
Item
subjects with idiopathic parkinson's disease and early wearing-off symptoms treated with standard levodopa/ddci treatment
boolean
C0030567 (UMLS CUI [1])
C0023570 (UMLS CUI [2])
C0598272 (UMLS CUI [3])
C1504539 (UMLS CUI [4,1])
C1279919 (UMLS CUI [4,2])
Age
Item
age >35 - years
boolean
C0001779 (UMLS CUI [1])
Hoehn and Yahr Stage | Pharmaceutical Preparations Use of
Item
hoehn and yahr stage 1-3 performed during the 'on'-stage
boolean
C3639483 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
Symptoms Quantity Identified Wearing off Questionnaire
Item
at least 1 symptom identified by woq-9
boolean
C1457887 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205396 (UMLS CUI [1,3])
C1504539 (UMLS CUI [1,4])
C0034394 (UMLS CUI [1,5])
Levodopa Dose U/day Maximum | DOPA Decarboxylase Inhibitors Dose Frequency
Item
dosing frequency of 3-4 doses of standard-release levodopa/ddci (maximum total daily dose of 600 mg of levodopa)
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
C0598272 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0439603 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Atypical Parkinson Disease | Secondary Parkinson Disease
Item
atypical or symptomatic parkinson's disease
boolean
C1868596 (UMLS CUI [1])
C0030569 (UMLS CUI [2])
UPDRS - Off Periods Unpredictable
Item
unpredictable off-periods
boolean
C3639872 (UMLS CUI [1])
Dyskinetic syndrome Peak Dose | Dystonia Pharmaceutical Preparations Off
Item
any peak-dose dyskinesia. 'off'-state dystonia is allowed
boolean
C0013384 (UMLS CUI [1,1])
C0444505 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0013421 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1518543 (UMLS CUI [2,3])
Pharmaceutical Preparations Additional | Levodopa Dose Quantity | DOPA Decarboxylase Inhibitors Dose Quantity
Item
use of any rescue medications to treat symptoms of 'off'-state. 1 dose of soluble levodopa/ddci is allowed.
boolean
C0013227 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0023570 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0598272 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Monoamine oxidase inhibitors, non-selective | Monoamine Oxidase-A Inhibitors High dose | Monoamine Oxidase-B Inhibitors High dose | Selegiline Dose | Rasagiline Dose | Apomorphine
Item
concomitant treatment with non-selective monoamine oxidase (mao) inhibitor or simultaneous use of higher than recommended doses of mao-a and mao-b inhibitors (selegiline 10 mg or rasagiline 1 mg allowed) or use of apomorphine.
boolean
C3653330 (UMLS CUI [1])
C2917289 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C2917290 (UMLS CUI [3,1])
C0444956 (UMLS CUI [3,2])
C0036579 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0525678 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0003596 (UMLS CUI [6])
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