Informed Consent
Item
1. able to understand and willing to voluntarily sign an informed consent form (icf) and health insurance portability and accountability act (hipaa) authorization or local equivalent if applicable.
boolean
C0021430 (UMLS CUI [1])
Parkinson Disease
Item
2. diagnosed with idiopathic pd.
boolean
C0030567 (UMLS CUI [1])
Levodopa naive | Absence Exposure to Levodopa | Absence Exposure to Catechol-O-methyltransferase inhibitor
Item
3. ld-naïve: defined as subjects not exposed to ld or catechol-o-methyl transferase inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study enrollment.
boolean
C0023570 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0023570 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C0595267 (UMLS CUI [3,3])
Anticholinergic Agents Therapy Stable | Amantadine | MAO-B Inhibitor
Item
4. if currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type b (mao-b) inhibitor, maintains a stable regimen for at least 4 weeks prior to baseline, and agrees to maintain the stable regimen throughout study participation.
boolean
C0242896 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0002403 (UMLS CUI [2])
C2917433 (UMLS CUI [3])
Contraceptive methods Agreement
Item
5. agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
boolean
C0700589 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
Protocol Compliance | Patient Available Clinic Visits | Patient Available Telephone call
Item
6. able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.
boolean
C0525058 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C0008952 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C0470187 (UMLS CUI [3,2])
C0302186 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
1. pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Atypical Parkinsonism | Secondary Parkinson Disease
Item
2. diagnosed with atypical parkinsonism or any known secondary parkinsonian syndrome.
boolean
C4302185 (UMLS CUI [1])
C0030569 (UMLS CUI [2])
Neurosurgical Procedures Functional Parkinson Disease | Neurosurgical Procedures Anticipated
Item
3. prior functional neurosurgical treatment for pd or if such procedures are anticipated during study participation.
boolean
C0524850 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0524850 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Monoamine oxidase inhibitors, non-selective
Item
4. use of nonselective mao inhibitors.
boolean
C3653330 (UMLS CUI [1])
Dopamine Agonists
Item
5. use of dopamine agonists within 30 days prior to screening.
boolean
C0178601 (UMLS CUI [1])
Placebo study Receive Unable
Item
6. unable to tolerate a placebo regimen, in the investigator's opinion.
boolean
C0683952 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Treatment Psychotic Disorders | Antipsychotic Agents
Item
7. treatment of psychosis with any antipsychotic.
boolean
C0087111 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2])
Epilepsy
Item
8. history of seizure or epilepsy.
boolean
C0014544 (UMLS CUI [1])
Medical condition Interferes with Levodopa Absorption | Operative Surgical Procedure Interferes with Levodopa Absorption
Item
9. active or prior medical condition or prior surgical procedure that would interfere with ld absorption.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
C0237442 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0023570 (UMLS CUI [2,3])
C0237442 (UMLS CUI [2,4])
Angle Closure Glaucoma
Item
10. history of narrow-angle glaucoma.
boolean
C0017605 (UMLS CUI [1])
Melanoma
Item
11. subjects with a history of malignant melanoma.
boolean
C0025202 (UMLS CUI [1])
Myocardial Infarction | Atrial arrhythmia Residual | Nodal rhythm disorder Residual | Ventricular arrhythmia Residual | Upper gastrointestinal hemorrhage | Neuroleptic Malignant Syndrome
Item
12. history of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
boolean
C0027051 (UMLS CUI [1])
C0085611 (UMLS CUI [2,1])
C1609982 (UMLS CUI [2,2])
C0264893 (UMLS CUI [3,1])
C1609982 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4,1])
C1609982 (UMLS CUI [4,2])
C0041909 (UMLS CUI [5])
C0027849 (UMLS CUI [6])
Investigational New Drugs
Item
13. received any investigational medications during the 30 days prior to screening.
boolean
C0013230 (UMLS CUI [1])