ID

31411

Description

Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT; ODM derived from: https://clinicaltrials.gov/show/NCT00566462

Link

https://clinicaltrials.gov/show/NCT00566462

Keywords

Versions (1)
  1. 8/20/18 8/20/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 20, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00566462

English

Eligibility Parkinson's Disease NCT00566462

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients with idiopathic pd fulfilling the united kingdom parkinson's disease society brain bank (ukpdsbb) diagnostic criteria, with a good response to levodopa. the requirement in the ukpdsbb step 2 for prior brain imaging is at the discretion of the investigator.
Description

Parkinson Disease | Good response to Levodopa treatment | Imaging of brain

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C4228950
UMLS CUI [3]
C0203860
clinical diagnosis of idiopathic parkinson's disease (patients must have at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia)
Description

Parkinson Disease | Symptoms Main Quantity | Resting Tremor | Muscle Rigidity | Bradykinesia

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0234379
UMLS CUI [4]
C0026837
UMLS CUI [5]
C0233565
hoehn and yahr stage ii to iv.
Description

Hoehn and Yahr Stage

Data type

boolean

Alias
UMLS CUI [1]
C3639483
treatment with monotherapy of levodopa plus an aromatic acid decarboxylase inhibitor (carbidopa). the carbidopa/levodopa medication should be taken at least two times daily (excluding the bedtime/night time dose) up to a maximum of eight doses daily (including the bedtime/night time dose).
Description

Levodopa | Aromatic Amino Acid Decarboxylase Inhibitors | Carbidopa / Levodopa Dose Quantity Daily

Data type

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C3850100
UMLS CUI [3,1]
C0353697
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0332173
intermittent use of either liquid forms of levodopa or subcutaneous apomorphine is permitted.
Description

Levodopa Liquid | Apomorphine Subcutaneous

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C1697794
UMLS CUI [2,1]
C0003596
UMLS CUI [2,2]
C1522438
age >30 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
women who are incapable of bearing children (e.g., clinically assessed as infertile, including surgically sterile) or who are practicing effective contraception (e.g., abstinence, intrauterine device or barrier method plus hormonal method).
Description

Gender | Infertility | Female Sterilization | Contraceptive methods | Sexual Abstinence | Intrauterine Devices | Contraception, Barrier | Hormonal contraception

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0021359
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0700589
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0004764
UMLS CUI [8]
C2985296
postmenopausal women may be recruited but must be amenorrheic for at least 1 year to be considered. women must have a negative serum beta-human chorionic gondotrophin (β-hcg) test at the screening visit and a negative urine pregnancy test prior to radiotracer administration on the day of each spect scanning session. women must also be willing to remain on their current form of contraception for the duration of the study.
Description

Postmenopausal state | Gender | Pregnancy test negative beta hcg serum | Urine pregnancy test negative | Radiotracer Administration | SPECT | Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0427780
UMLS CUI [3,2]
C0741474
UMLS CUI [4]
C0430057
UMLS CUI [5,1]
C0597354
UMLS CUI [5,2]
C1533734
UMLS CUI [6]
C0040399
UMLS CUI [7]
C0700589
2. in the investigator's opinion, patients are able to complete the study and are capable of giving full written informed consent.
Description

Completion of clinical trial Able | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C2732579
UMLS CUI [1,2]
C0085732
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with any one of the following will be excluded:
Description

Patients Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332196
1. inability or unwillingness to undergo spect or other study procedures
Description

SPECT Receive Unable | SPECT Receive Unwilling | Study procedure Receive Unable | Study procedure Receive Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0040399
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0040399
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C2603343
UMLS CUI [3,2]
C0184661
UMLS CUI [3,3]
C1514756
UMLS CUI [3,4]
C1299582
UMLS CUI [4,1]
C2603343
UMLS CUI [4,2]
C0184661
UMLS CUI [4,3]
C1514756
UMLS CUI [4,4]
C0558080
2. pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. atypical or drug-induced pd
Description

Atypical Parkinson Disease | Parkinsonism due to drug

Data type

boolean

Alias
UMLS CUI [1]
C1868596
UMLS CUI [2]
C0270729
4. current treatment with dopamine agonists, mao or comt inhibitors, anticholinergics
Description

Dopamine Agonists | Monoamine Oxidase Inhibitors | COMT Inhibitors | Anticholinergic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0178601
UMLS CUI [2]
C0026457
UMLS CUI [3]
C2917201
UMLS CUI [4]
C0242896
5. patients with a past (within 1 year) or present history of psychotic symptoms requiring antipsychotic treatment. patients may be taking antidepressant medication, however, the dose must be stable for 4 weeks prior to the baseline visit. use of antipsychotic medication including clozapine and quetiapine is prohibited, even if the indication is for movement disorders.
Description

Psychotic symptoms Requirement Antipsychotic drug therapy | Antidepressive Agents Dose Stable allowed | Antipsychotic Agents | Clozapine | Quetiapine

Data type

boolean

Alias
UMLS CUI [1,1]
C0871189
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1319421
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0683607
UMLS CUI [3]
C0040615
UMLS CUI [4]
C0009079
UMLS CUI [5]
C0123091
6. current or prior treatment (within 4 weeks prior to baseline visit) with pergolide, tolcapone, methyldopa, budipine, reserpine, seroquel, or the herbal dopamine agonist, mucuna pruriens
Description

Pergolide | tolcapone | Methyldopa | budipine | Reserpine | Seroquel | Dopamine Agonists Herbal | Mucuna pruriens extract

Data type

boolean

Alias
UMLS CUI [1]
C0031007
UMLS CUI [2]
C0246330
UMLS CUI [3]
C0025741
UMLS CUI [4]
C0054202
UMLS CUI [5]
C0035179
UMLS CUI [6]
C0287163
UMLS CUI [7,1]
C0178601
UMLS CUI [7,2]
C3146288
UMLS CUI [8]
C3503113
7. patients with current or prior treatment (within 4 weeks prior to the baseline visit) with medication known to induce the enzyme cytochrome p450 3a4
Description

CYP3A4 Inducer

Data type

boolean

Alias
UMLS CUI [1]
C3830625
8. use of an investigational product within 4 weeks prior to randomization or patients who have participated in a previous study with perampanel
Description

Investigational New Drugs | Study Subject Participation Status | perampanel

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
UMLS CUI [3]
C2698764
9. patients with a past or present history of drug or alcohol abuse as per diagnostic and statistical manual - 4th edition (dsm iv) criteria
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
10. dementia (as defined by a mmse score of ≤ 24) and/or fulfilling the criteria for dementia due to pd (as defined by the diagnostic and statistical manual of the american psychiatric association - 4th edition)
Description

Dementia | Dementia due to Parkinson's disease

Data type

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0236960
11. clinically significant unstable medical or psychiatric illness
Description

Disease Unstable | Mental disorders Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0443343
12. presence of physical, mental, or social condition that precludes informed consent or interferes with careful follow-up
Description

Physical Condition Excludes Informed Consent | Mental condition Excludes Informed Consent | Social Condition Excludes Informed Consent | Physical Condition Interferes with Follow-up | Mental condition Interferes with Follow-up | Social Condition Interferes with Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C3714565
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0037403
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3714565
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C3274571
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C3274571
UMLS CUI [6,1]
C0037403
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C3274571
13. past (within 1 year) or present history of suicidal ideation or suicide attempts
Description

Feeling suicidal | Suicide attempt

Data type

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C0038663
14. elevations of liver enzymes, alanine aminotransferase (alt), and aspartate aminotransferase (ast) ≥ 1.5 times the upper limit of normal (uln)
Description

Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0235996
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
15. patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastrointestinal, haematological, endocrine, or metabolic systems that might complicate assessment of the tolerability of the study medication
Description

Liver function Unstable | Renal function Unstable | Abnormal cardiovascular function Unstable | Respiratory function Unstable | Gastrointestinal function Unstable | Hematologic function Unstable | Endocrine function Unstable | Metabolic function abnormal Unstable | Assessment Investigational Drug Difficult

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0232090
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0035203
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0516983
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0221130
UMLS CUI [6,2]
C0443343
UMLS CUI [7,1]
C0678896
UMLS CUI [7,2]
C0443343
UMLS CUI [8,1]
C0438213
UMLS CUI [8,2]
C0443343
UMLS CUI [9,1]
C1516048
UMLS CUI [9,2]
C0013230
UMLS CUI [9,3]
C0332218
16. evidence of significant active hematological disease: white blood cell (wbc) count ≤
Description

Hematological Disease | White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0023508
2500/μl; absolute neutrophil count ≤ 1000/μl
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
17. patients with previous stereotactic surgery (eg, pallidotomy) for parkinson's disease or with planned stereotactic surgery during the study period
Description

Stereotactic surgery Parkinson Disease | Pallidotomy Parkinson Disease | Stereotactic surgery Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C1735594
UMLS CUI [1,2]
C0030567
UMLS CUI [2,1]
C0195893
UMLS CUI [2,2]
C0030567
UMLS CUI [3,1]
C1735594
UMLS CUI [3,2]
C1301732
18. patients receiving or planning to receive (within 3 months) deep brain stimulation
Description

Deep Brain Stimulation | Deep Brain Stimulation Planned

Data type

boolean

Alias
UMLS CUI [1]
C0394162
UMLS CUI [2,1]
C0394162
UMLS CUI [2,2]
C1301732
19. patients with conditions affecting the peripheral or central sensory system unless related to parkinson's disease (such as mild sensory or pain syndromes limited to "off" periods) that could interfere with the evaluation of any such symptoms caused by the study drug
Description

Condition Affecting Peripheral sensory structure | Condition Affecting Sensory nervous system Central | Exception Relationship Parkinson Disease | Sensory Disorder Mild | Pain Disorder Mild | Interference Evaluation Investigational Drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0228102
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0682648
UMLS CUI [2,4]
C0205099
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0030567
UMLS CUI [4,1]
C0152027
UMLS CUI [4,2]
C2945599
UMLS CUI [5,1]
C0391976
UMLS CUI [5,2]
C2945599
UMLS CUI [6,1]
C0521102
UMLS CUI [6,2]
C1261322
UMLS CUI [6,3]
C0013230
20. patients with any condition that would make the patient, in the opinion of the investigator, unsuitable for the study
Description

Condition Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
21. patients with clinically significant ecg abnormality, including prolonged qtc (defined as qtc > 450 msec)
Description

Electrocardiogram abnormal | Prolonged QTc

Data type

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C1969409
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Similar models

Eligibility Parkinson's Disease NCT00566462

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Good response to Levodopa treatment | Imaging of brain
Item
1. male or female patients with idiopathic pd fulfilling the united kingdom parkinson's disease society brain bank (ukpdsbb) diagnostic criteria, with a good response to levodopa. the requirement in the ukpdsbb step 2 for prior brain imaging is at the discretion of the investigator.
boolean
C0030567 (UMLS CUI [1])
C4228950 (UMLS CUI [2])
C0203860 (UMLS CUI [3])
Parkinson Disease | Symptoms Main Quantity | Resting Tremor | Muscle Rigidity | Bradykinesia
Item
clinical diagnosis of idiopathic parkinson's disease (patients must have at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia)
boolean
C0030567 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0234379 (UMLS CUI [3])
C0026837 (UMLS CUI [4])
C0233565 (UMLS CUI [5])
Hoehn and Yahr Stage
Item
hoehn and yahr stage ii to iv.
boolean
C3639483 (UMLS CUI [1])
Levodopa | Aromatic Amino Acid Decarboxylase Inhibitors | Carbidopa / Levodopa Dose Quantity Daily
Item
treatment with monotherapy of levodopa plus an aromatic acid decarboxylase inhibitor (carbidopa). the carbidopa/levodopa medication should be taken at least two times daily (excluding the bedtime/night time dose) up to a maximum of eight doses daily (including the bedtime/night time dose).
boolean
C0023570 (UMLS CUI [1])
C3850100 (UMLS CUI [2])
C0353697 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0332173 (UMLS CUI [3,4])
Levodopa Liquid | Apomorphine Subcutaneous
Item
intermittent use of either liquid forms of levodopa or subcutaneous apomorphine is permitted.
boolean
C0023570 (UMLS CUI [1,1])
C1697794 (UMLS CUI [1,2])
C0003596 (UMLS CUI [2,1])
C1522438 (UMLS CUI [2,2])
Age
Item
age >30 years of age
boolean
C0001779 (UMLS CUI [1])
Gender | Infertility | Female Sterilization | Contraceptive methods | Sexual Abstinence | Intrauterine Devices | Contraception, Barrier | Hormonal contraception
Item
women who are incapable of bearing children (e.g., clinically assessed as infertile, including surgically sterile) or who are practicing effective contraception (e.g., abstinence, intrauterine device or barrier method plus hormonal method).
boolean
C0079399 (UMLS CUI [1])
C0021359 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
C2985296 (UMLS CUI [8])
Postmenopausal state | Gender | Pregnancy test negative beta hcg serum | Urine pregnancy test negative | Radiotracer Administration | SPECT | Contraceptive methods
Item
postmenopausal women may be recruited but must be amenorrheic for at least 1 year to be considered. women must have a negative serum beta-human chorionic gondotrophin (β-hcg) test at the screening visit and a negative urine pregnancy test prior to radiotracer administration on the day of each spect scanning session. women must also be willing to remain on their current form of contraception for the duration of the study.
boolean
C0232970 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0427780 (UMLS CUI [3,1])
C0741474 (UMLS CUI [3,2])
C0430057 (UMLS CUI [4])
C0597354 (UMLS CUI [5,1])
C1533734 (UMLS CUI [5,2])
C0040399 (UMLS CUI [6])
C0700589 (UMLS CUI [7])
Completion of clinical trial Able | Informed Consent
Item
2. in the investigator's opinion, patients are able to complete the study and are capable of giving full written informed consent.
boolean
C2732579 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Patients Excluded
Item
patients with any one of the following will be excluded:
boolean
C0030705 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
SPECT Receive Unable | SPECT Receive Unwilling | Study procedure Receive Unable | Study procedure Receive Unwilling
Item
1. inability or unwillingness to undergo spect or other study procedures
boolean
C0040399 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0040399 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C2603343 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C1514756 (UMLS CUI [3,3])
C1299582 (UMLS CUI [3,4])
C2603343 (UMLS CUI [4,1])
C0184661 (UMLS CUI [4,2])
C1514756 (UMLS CUI [4,3])
C0558080 (UMLS CUI [4,4])
Pregnancy | Breast Feeding
Item
2. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Atypical Parkinson Disease | Parkinsonism due to drug
Item
3. atypical or drug-induced pd
boolean
C1868596 (UMLS CUI [1])
C0270729 (UMLS CUI [2])
Dopamine Agonists | Monoamine Oxidase Inhibitors | COMT Inhibitors | Anticholinergic Agents
Item
4. current treatment with dopamine agonists, mao or comt inhibitors, anticholinergics
boolean
C0178601 (UMLS CUI [1])
C0026457 (UMLS CUI [2])
C2917201 (UMLS CUI [3])
C0242896 (UMLS CUI [4])
Psychotic symptoms Requirement Antipsychotic drug therapy | Antidepressive Agents Dose Stable allowed | Antipsychotic Agents | Clozapine | Quetiapine
Item
5. patients with a past (within 1 year) or present history of psychotic symptoms requiring antipsychotic treatment. patients may be taking antidepressant medication, however, the dose must be stable for 4 weeks prior to the baseline visit. use of antipsychotic medication including clozapine and quetiapine is prohibited, even if the indication is for movement disorders.
boolean
C0871189 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1319421 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
C0040615 (UMLS CUI [3])
C0009079 (UMLS CUI [4])
C0123091 (UMLS CUI [5])
Pergolide | tolcapone | Methyldopa | budipine | Reserpine | Seroquel | Dopamine Agonists Herbal | Mucuna pruriens extract
Item
6. current or prior treatment (within 4 weeks prior to baseline visit) with pergolide, tolcapone, methyldopa, budipine, reserpine, seroquel, or the herbal dopamine agonist, mucuna pruriens
boolean
C0031007 (UMLS CUI [1])
C0246330 (UMLS CUI [2])
C0025741 (UMLS CUI [3])
C0054202 (UMLS CUI [4])
C0035179 (UMLS CUI [5])
C0287163 (UMLS CUI [6])
C0178601 (UMLS CUI [7,1])
C3146288 (UMLS CUI [7,2])
C3503113 (UMLS CUI [8])
CYP3A4 Inducer
Item
7. patients with current or prior treatment (within 4 weeks prior to the baseline visit) with medication known to induce the enzyme cytochrome p450 3a4
boolean
C3830625 (UMLS CUI [1])
Investigational New Drugs | Study Subject Participation Status | perampanel
Item
8. use of an investigational product within 4 weeks prior to randomization or patients who have participated in a previous study with perampanel
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C2698764 (UMLS CUI [3])
Substance Use Disorders
Item
9. patients with a past or present history of drug or alcohol abuse as per diagnostic and statistical manual - 4th edition (dsm iv) criteria
boolean
C0038586 (UMLS CUI [1])
Dementia | Dementia due to Parkinson's disease
Item
10. dementia (as defined by a mmse score of ≤ 24) and/or fulfilling the criteria for dementia due to pd (as defined by the diagnostic and statistical manual of the american psychiatric association - 4th edition)
boolean
C0497327 (UMLS CUI [1])
C0236960 (UMLS CUI [2])
Disease Unstable | Mental disorders Unstable
Item
11. clinically significant unstable medical or psychiatric illness
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Physical Condition Excludes Informed Consent | Mental condition Excludes Informed Consent | Social Condition Excludes Informed Consent | Physical Condition Interferes with Follow-up | Mental condition Interferes with Follow-up | Social Condition Interferes with Follow-up
Item
12. presence of physical, mental, or social condition that precludes informed consent or interferes with careful follow-up
boolean
C3714565 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0037403 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3714565 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C3274571 (UMLS CUI [5,3])
C0037403 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C3274571 (UMLS CUI [6,3])
Feeling suicidal | Suicide attempt
Item
13. past (within 1 year) or present history of suicidal ideation or suicide attempts
boolean
C0424000 (UMLS CUI [1])
C0038663 (UMLS CUI [2])
Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
14. elevations of liver enzymes, alanine aminotransferase (alt), and aspartate aminotransferase (ast) ≥ 1.5 times the upper limit of normal (uln)
boolean
C0235996 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Liver function Unstable | Renal function Unstable | Abnormal cardiovascular function Unstable | Respiratory function Unstable | Gastrointestinal function Unstable | Hematologic function Unstable | Endocrine function Unstable | Metabolic function abnormal Unstable | Assessment Investigational Drug Difficult
Item
15. patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastrointestinal, haematological, endocrine, or metabolic systems that might complicate assessment of the tolerability of the study medication
boolean
C0232741 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0232090 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0035203 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0516983 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0221130 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0678896 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0438213 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C1516048 (UMLS CUI [9,1])
C0013230 (UMLS CUI [9,2])
C0332218 (UMLS CUI [9,3])
Hematological Disease | White Blood Cell Count procedure
Item
16. evidence of significant active hematological disease: white blood cell (wbc) count ≤
boolean
C0018939 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
Absolute neutrophil count
Item
2500/μl; absolute neutrophil count ≤ 1000/μl
boolean
C0948762 (UMLS CUI [1])
Stereotactic surgery Parkinson Disease | Pallidotomy Parkinson Disease | Stereotactic surgery Planned
Item
17. patients with previous stereotactic surgery (eg, pallidotomy) for parkinson's disease or with planned stereotactic surgery during the study period
boolean
C1735594 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0195893 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
C1735594 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Deep Brain Stimulation | Deep Brain Stimulation Planned
Item
18. patients receiving or planning to receive (within 3 months) deep brain stimulation
boolean
C0394162 (UMLS CUI [1])
C0394162 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Condition Affecting Peripheral sensory structure | Condition Affecting Sensory nervous system Central | Exception Relationship Parkinson Disease | Sensory Disorder Mild | Pain Disorder Mild | Interference Evaluation Investigational Drug
Item
19. patients with conditions affecting the peripheral or central sensory system unless related to parkinson's disease (such as mild sensory or pain syndromes limited to "off" periods) that could interfere with the evaluation of any such symptoms caused by the study drug
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0228102 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0682648 (UMLS CUI [2,3])
C0205099 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0030567 (UMLS CUI [3,3])
C0152027 (UMLS CUI [4,1])
C2945599 (UMLS CUI [4,2])
C0391976 (UMLS CUI [5,1])
C2945599 (UMLS CUI [5,2])
C0521102 (UMLS CUI [6,1])
C1261322 (UMLS CUI [6,2])
C0013230 (UMLS CUI [6,3])
Condition Study Subject Participation Status Inappropriate
Item
20. patients with any condition that would make the patient, in the opinion of the investigator, unsuitable for the study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
Electrocardiogram abnormal | Prolonged QTc
Item
21. patients with clinically significant ecg abnormality, including prolonged qtc (defined as qtc > 450 msec)
boolean
C0522055 (UMLS CUI [1])
C1969409 (UMLS CUI [2])
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