ID

15597

Description

Continued Efficacy and Safety of Apomorphine in Patients With Late-Stage Parkinsons Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00200525

Link

https://clinicaltrials.gov/show/NCT00200525

Keywords

Versions (1)
  1. 6/4/16 6/4/16 -
Uploaded on

June 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00200525

English

Eligibility Parkinson Disease NCT00200525

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults of any age ≥ 18
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
men and non-pregnant, non-lactating women
Description

pregnancy or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential had a negative serum (beta hcg) pre-study pregnancy test prior to randomization
Description

negative pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0427780
women of childbearing potential used an acceptable form of contraception
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
patients with a clinical diagnosis of idiopathic parkinson's disease, i.e., not induced by drugs or caused by other diseases;
Description

idiopathic parkinsons disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
patients classified as stage (ii-iv) of the hoehn and yahr scale for staging the severity of parkinson's disease
Description

hoehn and yahr scale

Data type

boolean

Alias
UMLS CUI [1]
C0451215
the patient must have been on an optimally maximized oral therapy regimen. optimized oral anti-parkinson medications must have included levodopa/carbidopa inhibitors, in either immediate or delayed release forms, plus at least one direct acting oral dopamine agonist for at least 30 days prior to randomization
Description

oral therapy regimen for parkinson

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0087111
patients must have been receiving apomorphine subcutaneous injections for rescue therapy for off events for at least three months
Description

apomorphine subcutaneous injections

Data type

boolean

Alias
UMLS CUI [1]
C0003596
the minimum apomorphine baseline-dosing requirement was an average of at least 2 doses per day over the week prior to enrollment.
Description

minimum apomorphine baseline-dosing

Data type

boolean

Alias
UMLS CUI [1,1]
C0003596
UMLS CUI [1,2]
C0178602
patients participating in protocol apo401, an open-label study primarily designed to collect safety data, were eligible for participation in this trial without termination of participation in apo401
Description

protocol apo401

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients under medical therapy for clinically significant psychoses or dementia not related to ingestion of anti-parkinson medications. (patients with hallucinations or other central adverse reactions associated solely with anti-parkinson medications were not excluded.)
Description

psychoses or dementia

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0497327
patients with a history of drug or alcohol dependency within one year prior to study enrollment
Description

drug or alcohol dependency

Data type

boolean

Alias
UMLS CUI [1]
C0038586
patients with unstable and clinically significant disease of cardiovascular (including orthostatic hypotension), hematologic (including coombs' positive hemolytic anemia), hepatic, renal, metabolic, respiratory, gastrointestinal or endocrinological systems or neoplasm within the three months before the start of the study.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patinets with a history of true allergy to morphine or its derivatives (including apomorphine), sulfur, sulfur containing medications, sulfites, sulfates, tigan(r)(trimethobenzamide).
Description

allergy to morphine or its derivatives

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0026549
patients treated with experimental agents (other than apomorphine intermittent subcutaneous injections) within 30 days before study entry. patients with participation in mylan-sponsored study apo202 were excluded from participation in this study.
Description

participation in another study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
patients whose apomorphine regimen was characterized by administration methods other than intermittent subcutaneous injection.
Description

apomorphine regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C0003596
UMLS CUI [1,2]
C0040808
patients who could not or would not sign an informed consent form.
Description

informed consent limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Parkinson Disease NCT00200525

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
adults of any age ≥ 18
boolean
C0001779 (UMLS CUI [1])
pregnancy or lactating
Item
men and non-pregnant, non-lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
negative pregnancy test
Item
women of childbearing potential had a negative serum (beta hcg) pre-study pregnancy test prior to randomization
boolean
C0427780 (UMLS CUI [1])
contraception
Item
women of childbearing potential used an acceptable form of contraception
boolean
C0700589 (UMLS CUI [1])
idiopathic parkinsons disease
Item
patients with a clinical diagnosis of idiopathic parkinson's disease, i.e., not induced by drugs or caused by other diseases;
boolean
C0030567 (UMLS CUI [1])
hoehn and yahr scale
Item
patients classified as stage (ii-iv) of the hoehn and yahr scale for staging the severity of parkinson's disease
boolean
C0451215 (UMLS CUI [1])
oral therapy regimen for parkinson
Item
the patient must have been on an optimally maximized oral therapy regimen. optimized oral anti-parkinson medications must have included levodopa/carbidopa inhibitors, in either immediate or delayed release forms, plus at least one direct acting oral dopamine agonist for at least 30 days prior to randomization
boolean
C0030567 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
apomorphine subcutaneous injections
Item
patients must have been receiving apomorphine subcutaneous injections for rescue therapy for off events for at least three months
boolean
C0003596 (UMLS CUI [1])
minimum apomorphine baseline-dosing
Item
the minimum apomorphine baseline-dosing requirement was an average of at least 2 doses per day over the week prior to enrollment.
boolean
C0003596 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
protocol apo401
Item
patients participating in protocol apo401, an open-label study primarily designed to collect safety data, were eligible for participation in this trial without termination of participation in apo401
boolean
C2348568 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
psychoses or dementia
Item
patients under medical therapy for clinically significant psychoses or dementia not related to ingestion of anti-parkinson medications. (patients with hallucinations or other central adverse reactions associated solely with anti-parkinson medications were not excluded.)
boolean
C0033975 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
drug or alcohol dependency
Item
patients with a history of drug or alcohol dependency within one year prior to study enrollment
boolean
C0038586 (UMLS CUI [1])
comorbidity
Item
patients with unstable and clinically significant disease of cardiovascular (including orthostatic hypotension), hematologic (including coombs' positive hemolytic anemia), hepatic, renal, metabolic, respiratory, gastrointestinal or endocrinological systems or neoplasm within the three months before the start of the study.
boolean
C0009488 (UMLS CUI [1])
allergy to morphine or its derivatives
Item
patinets with a history of true allergy to morphine or its derivatives (including apomorphine), sulfur, sulfur containing medications, sulfites, sulfates, tigan(r)(trimethobenzamide).
boolean
C0020517 (UMLS CUI [1,1])
C0026549 (UMLS CUI [1,2])
participation in another study
Item
patients treated with experimental agents (other than apomorphine intermittent subcutaneous injections) within 30 days before study entry. patients with participation in mylan-sponsored study apo202 were excluded from participation in this study.
boolean
C2348568 (UMLS CUI [1])
apomorphine regimen
Item
patients whose apomorphine regimen was characterized by administration methods other than intermittent subcutaneous injection.
boolean
C0003596 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
informed consent limited
Item
patients who could not or would not sign an informed consent form.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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