ID

17724

Description

Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist; ODM derived from: https://clinicaltrials.gov/show/NCT00643045

Link

https://clinicaltrials.gov/show/NCT00643045

Keywords

Versions (1)
  1. 9/30/16 9/30/16 -
Uploaded on

September 30, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Idiopathic Parkinson's Disease NCT00643045

English

Eligibility Idiopathic Parkinson's Disease NCT00643045

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a diagnosis of idiopathic parkinson's disease of less than 5 years duration, and a hoehn and yahr stage of i to iii,
Description

Parkinson Disease disease length | Hoehn and Yahr grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0451215
who were receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to visit 1 (screening).
Description

Dopamine Agonist Single Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0178601
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with medical conditions and/or taking concomitant medications that would have put them at risk, interfered with the study evaluations, or made them unable to complete the requirements of the study;
Description

medical condition Resulting in Patients At risk | Pharmaceutical Preparations Resulting in Patients At risk | medical condition Interferes with Evaluation | Pharmaceutical Preparations Interfere with Evaluation | medical condition Protocol Compliance Unable | Pharmaceutical Preparations Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C1444641
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0030705
UMLS CUI [2,4]
C1444641
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0220825
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0220825
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0525058
UMLS CUI [5,3]
C1299582
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C1299582
patients with a diagnosis or recent history of substance abuse,
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
a history of psychosis,
Description

Psychotic Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0033975
who were depressed,
Description

depressed

Data type

boolean

Alias
UMLS CUI [1]
C0497307
had evidence of dementia or cognitive dysfunction,
Description

Dementia Evidence of | Impaired cognition Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0332120
or who were experiencing end of dose wearing-off;
Description

Wearing off effect Dose End

Data type

boolean

Alias
UMLS CUI [1,1]
C1504539
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0444930
female patients of childbearing potential;
Description

Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
patients who have previously received safinamide.
Description

safinamide

Data type

boolean

Alias
UMLS CUI [1]
C1098261
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Similar models

Eligibility Idiopathic Parkinson's Disease NCT00643045

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease disease length | Hoehn and Yahr grades
Item
patients with a diagnosis of idiopathic parkinson's disease of less than 5 years duration, and a hoehn and yahr stage of i to iii,
boolean
C0030567 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0451215 (UMLS CUI [2])
Dopamine Agonist Single Dose Stable
Item
who were receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to visit 1 (screening).
boolean
C0178601 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
medical condition Resulting in Patients At risk | Pharmaceutical Preparations Resulting in Patients At risk | medical condition Interferes with Evaluation | Pharmaceutical Preparations Interfere with Evaluation | medical condition Protocol Compliance Unable | Pharmaceutical Preparations Protocol Compliance Unable
Item
patients with medical conditions and/or taking concomitant medications that would have put them at risk, interfered with the study evaluations, or made them unable to complete the requirements of the study;
boolean
C3843040 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0220825 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0220825 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0525058 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C0013227 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C1299582 (UMLS CUI [6,3])
Substance Use Disorders
Item
patients with a diagnosis or recent history of substance abuse,
boolean
C0038586 (UMLS CUI [1])
Psychotic Disorder
Item
a history of psychosis,
boolean
C0033975 (UMLS CUI [1])
depressed
Item
who were depressed,
boolean
C0497307 (UMLS CUI [1])
Dementia Evidence of | Impaired cognition Evidence of
Item
had evidence of dementia or cognitive dysfunction,
boolean
C0497327 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0338656 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Wearing off effect Dose End
Item
or who were experiencing end of dose wearing-off;
boolean
C1504539 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
Childbearing Potential
Item
female patients of childbearing potential;
boolean
C3831118 (UMLS CUI [1])
safinamide
Item
patients who have previously received safinamide.
boolean
C1098261 (UMLS CUI [1])
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