ID

40371

Description

A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01968031

Link

https://clinicaltrials.gov/show/NCT01968031

Keywords

Versions (1)
  1. 4/15/20 4/15/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 15, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Idiopathic Parkinson's Disease NCT01968031

English

Eligibility Idiopathic Parkinson's Disease NCT01968031

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
30 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
uk parkinson's disease society (ukpds) brain bank criteria (step 1 and 2) for pd
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
pd stages 2-4 in the on state for modified hoehn and yahr scale.
Description

Parkinson Disease Hoehn and Yahr Stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C3639483
on levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit
Description

Levodopa | Clinical Response Benefit

Data type

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2,1]
C4055223
UMLS CUI [2,2]
C0814225
taking at least 400mg levodopa combination daily and on stable regimen of any other anti-parkinsonian drugs (mao-b, comt, da) for at least 2 weeks prior to randomization
Description

Levodopa Combined Therapy Dose U/day | Antiparkinson Agents Stable | Monoamine Oxidase B | Catechol O-Methyltransferase | Dopamine

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0009429
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0456683
UMLS CUI [2,1]
C0003405
UMLS CUI [2,2]
C0205360
UMLS CUI [3]
C0026456
UMLS CUI [4]
C0007407
UMLS CUI [5]
C0013030
stable dopaminergic regimen for at least 4 weeks immediately prior to randomization
Description

Dopaminergic drug therapy Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C3267134
UMLS CUI [1,2]
C0205360
documented end-of-dose wearing-off and levodopa-induced dyskinesia
Description

Dose End | Wearing off | Levodopa-induced dyskinesias

Data type

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0444930
UMLS CUI [2]
C1504539
UMLS CUI [3]
C1970038
have an average of two hours of off time per day
Description

Pharmaceutical Preparations Absent hours/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0556974
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion.
Description

Apomorphine | Dopamine Antagonists | Levodopa Infusion gastrointestinal

Data type

boolean

Alias
UMLS CUI [1]
C0003596
UMLS CUI [2]
C0242702
UMLS CUI [3,1]
C0023570
UMLS CUI [3,2]
C0574032
UMLS CUI [3,3]
C0521362
subject who have had neurosurgical operation for pd
Description

Neurosurgical Procedure Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0524850
UMLS CUI [1,2]
C0030567
subjects taking a2a antagonist, potent cyp3a4 inhibitors, potent cyp34a inducers
Description

Adenosine A2A Receptor Antagonists | CYP3A4 Inhibitor Strong | CYP3A4 Inducer Strong

Data type

boolean

Alias
UMLS CUI [1,1]
C0255998
UMLS CUI [1,2]
C0243076
UMLS CUI [2,1]
C3830624
UMLS CUI [2,2]
C0442821
UMLS CUI [3,1]
C3830625
UMLS CUI [3,2]
C0442821
subjects who smoke > 5 cigarettes/day
Description

Tobacco use Number of cigarettes per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
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Similar models

Eligibility Idiopathic Parkinson's Disease NCT01968031

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
30 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease
Item
uk parkinson's disease society (ukpds) brain bank criteria (step 1 and 2) for pd
boolean
C0030567 (UMLS CUI [1])
Parkinson Disease Hoehn and Yahr Stage
Item
pd stages 2-4 in the on state for modified hoehn and yahr scale.
boolean
C0030567 (UMLS CUI [1,1])
C3639483 (UMLS CUI [1,2])
Levodopa | Clinical Response Benefit
Item
on levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit
boolean
C0023570 (UMLS CUI [1])
C4055223 (UMLS CUI [2,1])
C0814225 (UMLS CUI [2,2])
Levodopa Combined Therapy Dose U/day | Antiparkinson Agents Stable | Monoamine Oxidase B | Catechol O-Methyltransferase | Dopamine
Item
taking at least 400mg levodopa combination daily and on stable regimen of any other anti-parkinsonian drugs (mao-b, comt, da) for at least 2 weeks prior to randomization
boolean
C0023570 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0003405 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0026456 (UMLS CUI [3])
C0007407 (UMLS CUI [4])
C0013030 (UMLS CUI [5])
Dopaminergic drug therapy Stable
Item
stable dopaminergic regimen for at least 4 weeks immediately prior to randomization
boolean
C3267134 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Dose End | Wearing off | Levodopa-induced dyskinesias
Item
documented end-of-dose wearing-off and levodopa-induced dyskinesia
boolean
C0178602 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C1504539 (UMLS CUI [2])
C1970038 (UMLS CUI [3])
Pharmaceutical Preparations Absent hours/day
Item
have an average of two hours of off time per day
boolean
C0013227 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0556974 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Apomorphine | Dopamine Antagonists | Levodopa Infusion gastrointestinal
Item
subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion.
boolean
C0003596 (UMLS CUI [1])
C0242702 (UMLS CUI [2])
C0023570 (UMLS CUI [3,1])
C0574032 (UMLS CUI [3,2])
C0521362 (UMLS CUI [3,3])
Neurosurgical Procedure Parkinson Disease
Item
subject who have had neurosurgical operation for pd
boolean
C0524850 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Adenosine A2A Receptor Antagonists | CYP3A4 Inhibitor Strong | CYP3A4 Inducer Strong
Item
subjects taking a2a antagonist, potent cyp3a4 inhibitors, potent cyp34a inducers
boolean
C0255998 (UMLS CUI [1,1])
C0243076 (UMLS CUI [1,2])
C3830624 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C3830625 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
Tobacco use Number of cigarettes per day
Item
subjects who smoke > 5 cigarettes/day
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
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