ID

36156

Descripción

Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes; ODM derived from: https://clinicaltrials.gov/show/NCT02240030

Link

https://clinicaltrials.gov/show/NCT02240030

Palabras clave

Versiones (1)
  1. 18/4/19 18/4/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de abril de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Idiopathic Parkinson's Disease NCT02240030

Inglés

Eligibility Idiopathic Parkinson's Disease NCT02240030

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Parkinson Disease | Age

Tipo de datos

boolean

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

MDS-UPDRS - Hoehn and Yahr Stage

Tipo de datos

boolean

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

Pharmacotherapy Containing Levodopa | Requirement Pharmaceutical Preparation times/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0023570
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
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;
Descripción

Motor fluctuations hours/day Minimum | Levodopa | Disease Response

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1868976
UMLS CUI [1,2]
C0556974
UMLS CUI [1,3]
C1524031
UMLS CUI [2]
C0023570
UMLS CUI [3]
C1704632
are on stable pd medication regimen;
Descripción

Antiparkinson Agents Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0205360
total daily ld dose <1600 mg/day;
Descripción

Levodopa Dose U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
able to perform a spirometry maneuver in the on and off states
Descripción

Ability Perform Spirometry

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C0037981
normal cognition confirmed by mmse score ≥25 ;
Descripción

Normal cognition Mini-mental state examination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2712133
UMLS CUI [1,2]
C0451306
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females;
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Operative Surgical Procedures Parkinson Disease | Stereotactic surgery Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
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;
Descripción

Psychotic symptom Treatment required for | Feeling suicidal | Suicide attempt

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0871189
UMLS CUI [1,2]
C0332121
UMLS CUI [2]
C0424000
UMLS CUI [3]
C0038663
known contraindication to the use of levodopa;
Descripción

Medical contraindication Levodopa

Tipo de datos

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;
Descripción

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 compromises Patient safety | Comorbidity Severe compromises Patient safety | Abnormality compromises Patient safety | Finding compromises Patient safety

Tipo de datos

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]
C2945640
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C2945640
UMLS CUI [6,4]
C1113679
UMLS CUI [7,1]
C1704258
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C1113679
UMLS CUI [8,1]
C0243095
UMLS CUI [8,2]
C2945640
UMLS CUI [8,3]
C1113679
any any contraindication to performing routine spirometry.
Descripción

Medical contraindication Routine Spirometry

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0205547
UMLS CUI [1,3]
C0037981
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Similar models

Eligibility Idiopathic Parkinson's Disease NCT02240030

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
MDS-UPDRS - Hoehn and Yahr Stage
Item
hoehn and yahr stage 1-3 in an "on" state;
boolean
C3639483 (UMLS CUI [1])
Pharmacotherapy Containing Levodopa | Requirement Pharmaceutical Preparation times/day
Item
require levodopa-containing medication regimen at least 4 times during the waking day;
boolean
C0013216 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439511 (UMLS CUI [2,3])
Motor fluctuations hours/day Minimum | Levodopa | Disease Response
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])
C0556974 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0023570 (UMLS CUI [2])
C1704632 (UMLS CUI [3])
Antiparkinson Agents Stable
Item
are on stable pd medication regimen;
boolean
C0003405 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Levodopa Dose U/day
Item
total daily ld dose <1600 mg/day;
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Ability Perform Spirometry
Item
able to perform a spirometry maneuver in the on and off states
boolean
C0085732 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0037981 (UMLS CUI [1,3])
Normal cognition Mini-mental state examination
Item
normal cognition confirmed by mmse score ≥25 ;
boolean
C2712133 (UMLS CUI [1,1])
C0451306 (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])
Operative Surgical Procedures Parkinson Disease | Stereotactic surgery Planned
Item
previous surgery for pd or plan to have stereotactic surgery during the study period;
boolean
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C1735594 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Psychotic symptom Treatment required for | Feeling suicidal | Suicide attempt
Item
history of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
boolean
C0871189 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0424000 (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])
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 compromises Patient safety | Comorbidity Severe compromises Patient safety | Abnormality compromises Patient safety | Finding compromises 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])
C2945640 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C0009488 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C2945640 (UMLS CUI [6,3])
C1113679 (UMLS CUI [6,4])
C1704258 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C1113679 (UMLS CUI [7,3])
C0243095 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C1113679 (UMLS CUI [8,3])
Medical contraindication Routine Spirometry
Item
any any contraindication to performing routine spirometry.
boolean
C1301624 (UMLS CUI [1,1])
C0205547 (UMLS CUI [1,2])
C0037981 (UMLS CUI [1,3])
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