ID

15297

Description

Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes; ODM derived from: https://clinicaltrials.gov/show/NCT02242487

Link

https://clinicaltrials.gov/show/NCT02242487

Keywords

Versions (1)
  1. 5/25/16 5/25/16 -
Uploaded on

May 25, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Idiopathic Parkinson's Disease NCT02242487

English

Eligibility Idiopathic Parkinson's Disease NCT02242487

1 forms  
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 grades

Data type

boolean

Alias
UMLS CUI [1]
C0451215
require levodopa-containing medication regimen at least 4 times during the waking day;
Description

Levodopa Medication regimen Waking Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0237125
UMLS CUI [1,3]
C0442696
UMLS CUI [1,4]
C1514873
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 Waking | Levodopa Responsiveness

Data type

boolean

Alias
UMLS CUI [1,1]
C1868976
UMLS CUI [1,2]
C0442696
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0552602
are on stable pd medication regimen;
Description

Parkinson Disease Medication regimen Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0237125
UMLS CUI [1,3]
C0205360
total daily levodopa (ld) dose <1600 mg/day;
Description

Levodopa Daily Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C2348070
able to perform a spirometry maneuver in the on and off states
Description

Spirometry Ability

Data type

boolean

Alias
UMLS CUI [1,1]
C0037981
UMLS CUI [1,2]
C0085732
normal cognition confirmed by mini mental state examination (mmse) score ≥25 ;
Description

Actual Effective Cognition mini-mental status exam score

Data type

boolean

Alias
UMLS CUI [1,1]
C2712133
UMLS CUI [1,2]
C2225229
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

Parkinson Disease H/O: surgery | Stereotactic surgery Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0455610
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

Psychotic symptom Requirement Therapeutic procedure | Suicide ideation | Suicide attempt

Data type

boolean

Alias
UMLS CUI [1,1]
C0871189
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C1821181
UMLS CUI [3]
C0038663
known contraindication to the use of levodopa;
Description

Medical contraindication Levodopa

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0023570
any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
Description

Comorbidity Study Subject Participation Status Limited | Comorbidity At risk patient safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
any any contraindication to performing routine spirometry.
Description

Medical contraindication Spirometry

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0037981
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Similar models

Eligibility Idiopathic Parkinson's Disease NCT02242487

1 forms
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 grades
Item
hoehn and yahr stage 1-3 in an "on" state;
boolean
C0451215 (UMLS CUI [1])
Levodopa Medication regimen Waking Required
Item
require levodopa-containing medication regimen at least 4 times during the waking day;
boolean
C0023570 (UMLS CUI [1,1])
C0237125 (UMLS CUI [1,2])
C0442696 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
Motor fluctuations Waking | Levodopa Responsiveness
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 [1,1])
C0442696 (UMLS CUI [1,2])
C0023570 (UMLS CUI [2,1])
C0552602 (UMLS CUI [2,2])
Parkinson Disease Medication regimen Stable
Item
are on stable pd medication regimen;
boolean
C0030567 (UMLS CUI [1,1])
C0237125 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Levodopa Daily Dose
Item
total daily levodopa (ld) dose <1600 mg/day;
boolean
C0023570 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Spirometry Ability
Item
able to perform a spirometry maneuver in the on and off states
boolean
C0037981 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Actual Effective Cognition mini-mental status exam score
Item
normal cognition confirmed by mini mental state examination (mmse) score ≥25 ;
boolean
C2712133 (UMLS CUI [1,1])
C2225229 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating females;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Parkinson Disease H/O: surgery | Stereotactic surgery Planned
Item
previous surgery for pd or plan to have stereotactic surgery during the study period;
boolean
C0030567 (UMLS CUI [1,1])
C0455610 (UMLS CUI [1,2])
C1735594 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Psychotic symptom Requirement Therapeutic procedure | Suicide ideation | Suicide attempt
Item
history of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
boolean
C0871189 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1821181 (UMLS CUI [2])
C0038663 (UMLS CUI [3])
Medical contraindication Levodopa
Item
known contraindication to the use of levodopa;
boolean
C1301624 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
Comorbidity Study Subject Participation Status Limited | Comorbidity 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
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
Medical contraindication Spirometry
Item
any any contraindication to performing routine spirometry.
boolean
C1301624 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
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