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

Lien

https://clinicaltrials.gov/show/NCT01777555

Mots-clés

Versions (1)
  1. 14/04/2020 14/04/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

14 avril 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Idiopathic Parkinson's Disease NCT01777555

Anglais

Eligibility Idiopathic Parkinson's Disease NCT01777555

1 Formulaires  
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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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
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Similar models

Eligibility Idiopathic Parkinson's Disease NCT01777555

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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