Age
Item
subject is male or female, ≥18 years of age
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease | Signs Quantity | Bradykinesia | Resting Tremor | Rigidity | Postural instability
Item
subject has idiopathic parkinson's disease with at least 2 of the following cardinal signs being present: bradykinesia, resting tremor, rigidity or postural instability, and without any other known or suspected cause of parkinsonism
boolean
C0030567 (UMLS CUI [1])
C0311392 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0233565 (UMLS CUI [3])
C0234379 (UMLS CUI [4])
C0026837 (UMLS CUI [5])
C1843921 (UMLS CUI [6])
Hoehn and Yahr Stage
Item
subject has a hoehn and yahr stage score ≤4
boolean
C3639483 (UMLS CUI [1])
Symptoms Score | Exception Motor symptoms
Item
subject has a total non-motor symptoms scale (nmss) score ≥40
boolean
C1457887 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0426980 (UMLS CUI [2,2])
Levodopa Dose Stable | Benserazide / Levodopa | Carbidopa / Levodopa
Item
if the subject is taking levodopa (l-dopa), he/she must be on a stable dose of l-dopa (in combination with benserazide or carbidopa) for at least 28 days prior to the baseline visit
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0358787 (UMLS CUI [2])
C0353697 (UMLS CUI [3])
Anticholinergic Agents Dose Stable | Monoamine Oxidase Inhibitors Dose Stable | Amantadine Dose Stable
Item
if the subject is receiving anticholinergics, monoamine oxidase (mao) b inhibitors, or amantadine, he/she must have been on a stable dose for at least 28 days prior to the baseline visit and must be maintained on that dose for the duration of the study
boolean
C0242896 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0026457 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0002403 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Dopamine Agonists Discontinued | Etiology Lack of Efficacy
Item
subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator
boolean
C0178601 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0235828 (UMLS CUI [2,2])
Pharmacotherapy | Methyldopa | Metoclopramide | Reserpine | Antipsychotic Agents | Exception Antipsychotic Agents Atypical Specific | Exception Olanzapine | Exception Ziprasidone | Exception Aripiprazole | Exception Clozapine | Exception Quetiapine | Monoamine Oxidase Inhibitors | Methylphenidate | Amphetamine | Dopamine Agonists
Item
subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the baseline visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), monoamine oxidase-a (mao-a) inhibitors, methylphenidate, amphetamine, or other dopamine agonists (das)
boolean
C0013216 (UMLS CUI [1])
C0025741 (UMLS CUI [2])
C0025853 (UMLS CUI [3])
C0035179 (UMLS CUI [4])
C0040615 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0040615 (UMLS CUI [6,2])
C0205182 (UMLS CUI [6,3])
C0205369 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0171023 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0380393 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0299792 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C0009079 (UMLS CUI [10,2])
C1705847 (UMLS CUI [11,1])
C0123091 (UMLS CUI [11,2])
C0026457 (UMLS CUI [12])
C0025810 (UMLS CUI [13])
C0002658 (UMLS CUI [14])
C0178601 (UMLS CUI [15])
Central Nervous System Therapy | Sedatives | Hypnotics | Selective Serotonin Reuptake Inhibitors | Anti-Anxiety Agents | Sleep Disorder Agents | Exception Dose Stable Daily
Item
subject is receiving central nervous system (cns) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [ssris], anxiolytics, or other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to the baseline visit and is likely to remain stable for the duration of the study
boolean
C3714787 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0036557 (UMLS CUI [2])
C0020591 (UMLS CUI [3])
C0360105 (UMLS CUI [4])
C0040616 (UMLS CUI [5])
C4020625 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
C0332173 (UMLS CUI [7,4])
Impulse Control Disorder
Item
subject has evidence of an impulse control disorder according to the modified minnesota impulsive disorders interview at the screening visit (visit 1), confirmed by a positive structured clinical interview
boolean
C0021122 (UMLS CUI [1])