ID

40367

Description

Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes; ODM derived from: https://clinicaltrials.gov/show/NCT01777555

Link

https://clinicaltrials.gov/show/NCT01777555

Keywords

  1. 4/14/20 4/14/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 14, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Idiopathic Parkinson's Disease NCT01777555

Eligibility Idiopathic Parkinson's Disease NCT01777555

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
idiopathic parkinson's disease (pd) diagnosed between the ages of 30 and 80 years;
Description

Parkinson Disease | Age

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0001779
hoehn and yahr stage 1-3 in an "on" state;
Description

Hoehn and Yahr Stage

Data type

boolean

Alias
UMLS CUI [1]
C3639483
require levodopa-containing medication regimen at least 4 times during the waking day;
Description

Requirement Pharmacotherapy Levodopa | Levodopa times/day

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C0023570
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0439511
experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
Description

Motor fluctuations | Levodopa Responsive

Data type

boolean

Alias
UMLS CUI [1]
C1868976
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0205342
are on stable pd medication regimen.
Description

Pharmacotherapy Stable Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0030567
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females;
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous surgery for pd or plan to have stereotactic surgery during the study period;
Description

Prior surgery Parkinson Disease | Stereotactic surgery Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0030567
UMLS CUI [2,1]
C1735594
UMLS CUI [2,2]
C1301732
history of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
Description

Treatment required for Psychotic symptoms | Feeling suicidal | Suicide attempt

Data type

boolean

Alias
UMLS CUI [1,1]
C0332121
UMLS CUI [1,2]
C0871189
UMLS CUI [2]
C0424000
UMLS CUI [3]
C0038663
adequate lung function as measured by spirometry;
Description

Lung function Spirometry

Data type

boolean

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0037981
any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.
Description

Condition Study Subject Participation Status Inappropriate | Comorbidity Severe Study Subject Participation Status Inappropriate | Abnormality Study Subject Participation Status Inappropriate | Finding Study Subject Participation Status Inappropriate | Condition At risk Patient safety | Comorbidity Severe At risk Patient safety | Abnormality At risk Patient safety | Finding At risk Patient safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1548788
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1548788
UMLS CUI [4,1]
C0243095
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1548788
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C1444641
UMLS CUI [6,4]
C1113679
UMLS CUI [7,1]
C1704258
UMLS CUI [7,2]
C1444641
UMLS CUI [7,3]
C1113679
UMLS CUI [8,1]
C0243095
UMLS CUI [8,2]
C1444641
UMLS CUI [8,3]
C1113679

Similar models

Eligibility Idiopathic Parkinson's Disease NCT01777555

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Age
Item
idiopathic parkinson's disease (pd) diagnosed between the ages of 30 and 80 years;
boolean
C0030567 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hoehn and Yahr Stage
Item
hoehn and yahr stage 1-3 in an "on" state;
boolean
C3639483 (UMLS CUI [1])
Requirement Pharmacotherapy Levodopa | Levodopa times/day
Item
require levodopa-containing medication regimen at least 4 times during the waking day;
boolean
C1514873 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
C0023570 (UMLS CUI [2,1])
C0439511 (UMLS CUI [2,2])
Motor fluctuations | Levodopa Responsive
Item
experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
boolean
C1868976 (UMLS CUI [1])
C0023570 (UMLS CUI [2,1])
C0205342 (UMLS CUI [2,2])
Pharmacotherapy Stable Parkinson Disease
Item
are on stable pd medication regimen.
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating females;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior surgery Parkinson Disease | Stereotactic surgery Planned
Item
previous surgery for pd or plan to have stereotactic surgery during the study period;
boolean
C0455610 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C1735594 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Treatment required for Psychotic symptoms | Feeling suicidal | Suicide attempt
Item
history of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
boolean
C0332121 (UMLS CUI [1,1])
C0871189 (UMLS CUI [1,2])
C0424000 (UMLS CUI [2])
C0038663 (UMLS CUI [3])
Lung function Spirometry
Item
adequate lung function as measured by spirometry;
boolean
C0024119 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
Condition Study Subject Participation Status Inappropriate | Comorbidity Severe Study Subject Participation Status Inappropriate | Abnormality Study Subject Participation Status Inappropriate | Finding Study Subject Participation Status Inappropriate | Condition At risk Patient safety | Comorbidity Severe At risk Patient safety | Abnormality At risk Patient safety | Finding At risk Patient safety
Item
any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1548788 (UMLS CUI [2,4])
C1704258 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1548788 (UMLS CUI [3,3])
C0243095 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C0009488 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C1113679 (UMLS CUI [6,4])
C1704258 (UMLS CUI [7,1])
C1444641 (UMLS CUI [7,2])
C1113679 (UMLS CUI [7,3])
C0243095 (UMLS CUI [8,1])
C1444641 (UMLS CUI [8,2])
C1113679 (UMLS CUI [8,3])

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