Age
Item
be aged 30 to 85 years.
boolean
C0001779 (UMLS CUI [1])
Gender | Childbearing Potential Absent | Postmenopausal state | Female Sterilization | Childbearing Potential Contraceptive methods
Item
be male or female - female patients must be either not of childbearing potential (defined as post menopausal for at least one year or surgically incapable of bearing children), or must be practicing contraceptive methods as outlined in the protocol.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Parkinson Disease | Symptoms Quantity | Muscle Rigidity | Resting Tremor | Bradykinesia
Item
have a clinical diagnosis of idiopathic parkinson's disease, exhibiting at least 2 of 3 symptoms (rigidity, resting tremor, bradykinesia)
boolean
C0030567 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0026837 (UMLS CUI [3])
C0234379 (UMLS CUI [4])
C0233565 (UMLS CUI [5])
Symptoms End Dose Wearing off | Exception Motor symptoms | Symptoms Quantity Parkinson Disease | Improvement Carbidopa / Levodopa Immediate Release Dose
Item
have non-motor symptoms of end of dose wearing off i.e., the presence of at least one non-motor symptom of parkinson's disease which improves with the next immediate release (ir) carbidopa/levodopa dose as determined by the quantitative wearing-off questionnaire 9 and investigator's assessment. at least one non-motor item has to show a severity of at least 2 points (of a maximum of 4) and show an improvement of at least 1 one hour after immediate release (ir) carbidopa/levodopa administration. also there should not have been a deterioration of 1 point or more in another non-motor item.(all criteria must be fulfilled)
boolean
C1457887 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1504539 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0426980 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0030567 (UMLS CUI [3,3])
C2986411 (UMLS CUI [4,1])
C0353697 (UMLS CUI [4,2])
C1708470 (UMLS CUI [4,3])
Carbidopa / Levodopa Immediate Release Dose Stable | Carbidopa / Levodopa Immediate Release Total Dose U/day
Item
be taking a stable dose of immediate release (ir) carbidopa/levodopa for at least 21 days prior to randomization at an equivalent total daily dose of immediate release (ir) carbidopa/levodopa between 300 to 800 mg. dosing should be either 3 to 6 times per day.
boolean
C0353697 (UMLS CUI [1,1])
C1708470 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0353697 (UMLS CUI [2,1])
C1708470 (UMLS CUI [2,2])
C2986497 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Entacapone Unresponsive to Treatment | Tolcapone Unresponsive to Treatment | Serious Adverse Event | Adverse event Severe | Medication discontinued Entacapone | Medication discontinued Tolcapone | Entacapone | Tolcapone
Item
have a previous history of being non-responsive to entacapone or tolcapone treatment or having experienced a serious or severe adverse event(s) which resulted in the discontinuation of treatment from the previous use of entacapone or tolcapone; current treatment with entacapone or tolcapone or discontinued treatment with either therapy or discontinued less than 60 days before randomization;
boolean
C0165921 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0246330 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C1519255 (UMLS CUI [3])
C0877248 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0558681 (UMLS CUI [5,1])
C0165921 (UMLS CUI [5,2])
C0558681 (UMLS CUI [6,1])
C0246330 (UMLS CUI [6,2])
C0165921 (UMLS CUI [7])
C0246330 (UMLS CUI [8])
Secondary Parkinson Disease | Atypical Parkinsonism | Sign or Symptom Suggestive of Secondary Parkinson Disease | Sign or Symptom Suggestive of Atypical Parkinsonism
Item
have a history, signs, or symptoms suggesting a diagnosis of secondary or atypical parkinsonism;
boolean
C0030569 (UMLS CUI [1])
C4302185 (UMLS CUI [2])
C3540840 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0030569 (UMLS CUI [3,3])
C3540840 (UMLS CUI [4,1])
C0332299 (UMLS CUI [4,2])
C4302185 (UMLS CUI [4,3])
Parkinson Disease Unstable | Requirement Dose Additional Frequent
Item
have unstable parkinson's disease requiring frequent booster doses;
boolean
C0030567 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1524062 (UMLS CUI [2,3])
C0332183 (UMLS CUI [2,4])
Dyskinesia Disabling Unified Parkinson's Disease Rating Scale
Item
disabling dyskinesias, indicated by a score of greater than 1 on unified parkinson disease rating scale question #32, or a score of greater than 1 on unified parkinson disease rating scale question #33;
boolean
C0013384 (UMLS CUI [1,1])
C4061999 (UMLS CUI [1,2])
C3639721 (UMLS CUI [1,3])
Feature Psychotic
Item
have a history or current diagnosis of psychotic features according to the investigator;
boolean
C2348519 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria applied to the study.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])