ID

36779

Description

Phenylbutyrate Response as a Biomarker for Alpha-synuclein Clearance From the Brain; ODM derived from: https://clinicaltrials.gov/show/NCT02046434

Link

https://clinicaltrials.gov/show/NCT02046434

Keywords

Versions (1)
  1. 6/7/19 6/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 7, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT02046434

English

Eligibility Parkinson's Disease NCT02046434

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with idiopathic parkinson's disease and mild symptoms and not requiring symptomatic treatment with l-3,4-dihydroxyphenylalanine (l-dopa) or other anti-parkinson drugs. prior to entering the study, subjects may be on treatment with dopamine agonists provided that the treating neurologist agrees that the drugs can be stopped for at least three weeks prior to participating in the phenylbutyrate study and for the 4-week duration of the study.
Description

Parkinson Disease Symptom mild | Therapy Symptomatic Absent | Levodopa Absent | Antiparkinson Agents Absent | Dopamine Agonists To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0436343
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0023570
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0003405
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0178601
UMLS CUI [5,2]
C1272691
age- and sex-matched normal control subjects will be recruited from spouses and the general population.
Description

Healthy Control Age Matched | Healthy Control Gender Matched

Data type

boolean

Alias
UMLS CUI [1,1]
C2986479
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0150103
UMLS CUI [2,1]
C2986479
UMLS CUI [2,2]
C0079399
UMLS CUI [2,3]
C0150103
all subjects will be in good general health.
Description

Study Subject All General health good

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
UMLS CUI [1,3]
C1277245
candidates with hypertension or hypercholesterolemia controlled with medication are eligible.
Description

Hypertensive disease controlled with medications | Hypercholesterolemia controlled with medications

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0742801
UMLS CUI [2,1]
C0020443
UMLS CUI [2,2]
C0742801
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
because of possible drug interactions and the unknown teratogenic risk of phenylbutyrate, exclusion criteria for both patients and controls include:
Description

Exclusion Criteria Patients | Exclusion Criteria Control Groups

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0030705
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0009932
pregnant women
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
current treatment with l-3,4-dihydroxyphenylalanine (l-dopa), monoamine oxidase (mao) inhibitors, catechol-o-methyl transferase (comt) inhibitors, histone deacetylase (hdac) inhibitors, prednisone or other corticosteroids
Description

Levodopa | Monoamine Oxidase Inhibitors | Catechol O-Methyltransferase Inhibitors | Histone deacetylase inhibitor | Prednisone | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0026457
UMLS CUI [3]
C2917201
UMLS CUI [4]
C1512474
UMLS CUI [5]
C0032952
UMLS CUI [6]
C0001617
probenecid
Description

Probenecid

Data type

boolean

Alias
UMLS CUI [1]
C0033209
severe cardiopulmonary disease such as congestive heart failure or emphysema requiring supplemental oxygen.
Description

Cardiopulmonary disease Severe | Congestive heart failure | Pulmonary Emphysema Requirement Supplemental oxygen

Data type

boolean

Alias
UMLS CUI [1,1]
C0034072
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0018802
UMLS CUI [3,1]
C0034067
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C4534306
renal disease with serum creatinine greater than 2.5, history of depression in the prior year, epilepsy, stroke, prior brain surgery, dementia, or psychosis will also exclude candidates.
Description

Kidney Disease Associated with Serum creatinine raised | Depressive disorder | Epilepsy | Cerebrovascular accident | Operation on brain | Dementia | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0700225
UMLS CUI [2]
C0011581
UMLS CUI [3]
C0014544
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0195775
UMLS CUI [6]
C0497327
UMLS CUI [7]
C0033975
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Similar models

Eligibility Parkinson's Disease NCT02046434

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease Symptom mild | Therapy Symptomatic Absent | Levodopa Absent | Antiparkinson Agents Absent | Dopamine Agonists To be stopped
Item
patients with idiopathic parkinson's disease and mild symptoms and not requiring symptomatic treatment with l-3,4-dihydroxyphenylalanine (l-dopa) or other anti-parkinson drugs. prior to entering the study, subjects may be on treatment with dopamine agonists provided that the treating neurologist agrees that the drugs can be stopped for at least three weeks prior to participating in the phenylbutyrate study and for the 4-week duration of the study.
boolean
C0030567 (UMLS CUI [1,1])
C0436343 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0023570 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0003405 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0178601 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
Healthy Control Age Matched | Healthy Control Gender Matched
Item
age- and sex-matched normal control subjects will be recruited from spouses and the general population.
boolean
C2986479 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0150103 (UMLS CUI [1,3])
C2986479 (UMLS CUI [2,1])
C0079399 (UMLS CUI [2,2])
C0150103 (UMLS CUI [2,3])
Study Subject All General health good
Item
all subjects will be in good general health.
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1277245 (UMLS CUI [1,3])
Hypertensive disease controlled with medications | Hypercholesterolemia controlled with medications
Item
candidates with hypertension or hypercholesterolemia controlled with medication are eligible.
boolean
C0020538 (UMLS CUI [1,1])
C0742801 (UMLS CUI [1,2])
C0020443 (UMLS CUI [2,1])
C0742801 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Patients | Exclusion Criteria Control Groups
Item
because of possible drug interactions and the unknown teratogenic risk of phenylbutyrate, exclusion criteria for both patients and controls include:
boolean
C0680251 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C0009932 (UMLS CUI [2,2])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Levodopa | Monoamine Oxidase Inhibitors | Catechol O-Methyltransferase Inhibitors | Histone deacetylase inhibitor | Prednisone | Adrenal Cortex Hormones
Item
current treatment with l-3,4-dihydroxyphenylalanine (l-dopa), monoamine oxidase (mao) inhibitors, catechol-o-methyl transferase (comt) inhibitors, histone deacetylase (hdac) inhibitors, prednisone or other corticosteroids
boolean
C0023570 (UMLS CUI [1])
C0026457 (UMLS CUI [2])
C2917201 (UMLS CUI [3])
C1512474 (UMLS CUI [4])
C0032952 (UMLS CUI [5])
C0001617 (UMLS CUI [6])
Probenecid
Item
probenecid
boolean
C0033209 (UMLS CUI [1])
Cardiopulmonary disease Severe | Congestive heart failure | Pulmonary Emphysema Requirement Supplemental oxygen
Item
severe cardiopulmonary disease such as congestive heart failure or emphysema requiring supplemental oxygen.
boolean
C0034072 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0034067 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C4534306 (UMLS CUI [3,3])
Kidney Disease Associated with Serum creatinine raised | Depressive disorder | Epilepsy | Cerebrovascular accident | Operation on brain | Dementia | Psychotic Disorders
Item
renal disease with serum creatinine greater than 2.5, history of depression in the prior year, epilepsy, stroke, prior brain surgery, dementia, or psychosis will also exclude candidates.
boolean
C0022658 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0700225 (UMLS CUI [1,3])
C0011581 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0195775 (UMLS CUI [5])
C0497327 (UMLS CUI [6])
C0033975 (UMLS CUI [7])
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