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])
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])