ID

20288

Description

EMD 128130 for the Treatment of Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00009048

Link

https://clinicaltrials.gov/show/NCT00009048

Keywords

  1. 2/19/17 2/19/17 -
Uploaded on

February 19, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Parkinson's Disease NCT00009048

Eligibility Parkinson's Disease NCT00009048

Criteria
Description

Criteria

females must be either at least one year post-menopausal, or using an adequate contraceptive method for at least one month prior to and during participation in this study.
Description

contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
patients will carry the diagnosis of idiopathic parkinson's disease based on the presence of a characteristic clinical history and neurologic findings.
Description

idiopathic parkinsons disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
patients will have relatively advanced disease with levodopa-associated motor response complications, including peak-dose dyskinesias and wearing-off fluctuations.
Description

levodopa-associated motor response

Data type

boolean

Alias
UMLS CUI [1]
C1853846
patients with the presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk will be excluded.
Description

illness

Data type

boolean

Alias
UMLS CUI [1]
C0221423
patients with clinically significant laboratory abnormalities including liver enzyme elevations more than two times the upper limit of normal will be excluded.
Description

clinically significant laboratory abnormalities

Data type

boolean

Alias
UMLS CUI [1]
C1853129
patients who are unable to be treated with levodopa/carbidopa alone or with a single, relatively short-acting dopamine agonist will be excluded.
Description

levodopa responsive

Data type

boolean

Alias
UMLS CUI [1]
C1853846
patients with a form of parkinsonism other than idiopathic pd will be excluded.
Description

parkinson

Data type

boolean

Alias
UMLS CUI [1]
C0030567
patients with unacceptable prior/concomitant medications will be excluded.
Description

concomitant medications

Data type

boolean

Alias
UMLS CUI [1]
C2347852
no pregnant women. female and male patients must be practicing effective means of birth control.
Description

contraceptive methods and pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0032961
patients with prior bilateral surgical intervention for the treatment of parkinsonian symptoms, i.e. deep brain stimulation, pallidotomy, fetal tissue transplantation will be excluded.
Description

prior brain surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0195775
patients at risk for hypotension, cardiac arrhythmia, and/or myocardial ischemia secondary to intravenous levodopa challenge will not be eligible.
Description

risk for hypotension

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0020649
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0003811
UMLS CUI [3,1]
C0035648
UMLS CUI [3,2]
C0151744
patients with cognitive impairment (mmse less than 25) will not be eligible.
Description

cognitive impairment

Data type

boolean

Alias
UMLS CUI [1]
C0338656
patients with subnormal serum cortisol responses to acute acth stimulation will be excluded.
Description

serum cortisol and acth stimulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0236396
UMLS CUI [1,2]
C1696684

Similar models

Eligibility Parkinson's Disease NCT00009048

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
contraceptive methods
Item
females must be either at least one year post-menopausal, or using an adequate contraceptive method for at least one month prior to and during participation in this study.
boolean
C0700589 (UMLS CUI [1])
idiopathic parkinsons disease
Item
patients will carry the diagnosis of idiopathic parkinson's disease based on the presence of a characteristic clinical history and neurologic findings.
boolean
C0030567 (UMLS CUI [1])
levodopa-associated motor response
Item
patients will have relatively advanced disease with levodopa-associated motor response complications, including peak-dose dyskinesias and wearing-off fluctuations.
boolean
C1853846 (UMLS CUI [1])
illness
Item
patients with the presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk will be excluded.
boolean
C0221423 (UMLS CUI [1])
clinically significant laboratory abnormalities
Item
patients with clinically significant laboratory abnormalities including liver enzyme elevations more than two times the upper limit of normal will be excluded.
boolean
C1853129 (UMLS CUI [1])
levodopa responsive
Item
patients who are unable to be treated with levodopa/carbidopa alone or with a single, relatively short-acting dopamine agonist will be excluded.
boolean
C1853846 (UMLS CUI [1])
parkinson
Item
patients with a form of parkinsonism other than idiopathic pd will be excluded.
boolean
C0030567 (UMLS CUI [1])
concomitant medications
Item
patients with unacceptable prior/concomitant medications will be excluded.
boolean
C2347852 (UMLS CUI [1])
contraceptive methods and pregnancy
Item
no pregnant women. female and male patients must be practicing effective means of birth control.
boolean
C0700589 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
prior brain surgery
Item
patients with prior bilateral surgical intervention for the treatment of parkinsonian symptoms, i.e. deep brain stimulation, pallidotomy, fetal tissue transplantation will be excluded.
boolean
C0455610 (UMLS CUI [1,1])
C0195775 (UMLS CUI [1,2])
risk for hypotension
Item
patients at risk for hypotension, cardiac arrhythmia, and/or myocardial ischemia secondary to intravenous levodopa challenge will not be eligible.
boolean
C0035648 (UMLS CUI [1,1])
C0020649 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0003811 (UMLS CUI [2,2])
C0035648 (UMLS CUI [3,1])
C0151744 (UMLS CUI [3,2])
cognitive impairment
Item
patients with cognitive impairment (mmse less than 25) will not be eligible.
boolean
C0338656 (UMLS CUI [1])
serum cortisol and acth stimulation
Item
patients with subnormal serum cortisol responses to acute acth stimulation will be excluded.
boolean
C0236396 (UMLS CUI [1,1])
C1696684 (UMLS CUI [1,2])

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