Gender | Parkinson Disease
Item
male or female patient with idiopathic parkinson disease (pd) diagnosed for at least 2 years.
boolean
C0079399 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
Age
Item
patient aged 40 years or over at time of diagnosis of pd and not older than 80 years at screening visit.
boolean
C0001779 (UMLS CUI [1])
UPDRS - Modified Hoehn and Yahr Staging
Item
modified hoehn and yahr stage of ii to iii at "on" time.
boolean
C3639878 (UMLS CUI [1])
Levodopa Dose times/day Stable
Item
treatment with levodopa at an optimised dose, 4 to 8 times per day, this dose being stable for at least 4 weeks prior to screening visit.
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439511 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Motor fluctuations Duration Daily
Item
motor fluctuations, with 2.0 to 6.0 cumulative hours of "off" time every day during waking hours, documented from patient's diary completed for 2 consecutive days before baseline visit.
boolean
C1868976 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Exclusion Neurologic Psychiatric | Parkinson Disease | Dementia | Mini-mental state examination | Psychotic Disorders | Axis I diagnosis | Axis II diagnosis
Item
neuropsychiatric exclusions: non-idiopathic pd, dementia (mini mental state exam <26), history of psychosis, history or current axis i or axis ii mental disorder according to dsm-iv, etc
boolean
C2828389 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
C0205487 (UMLS CUI [1,3])
C0030567 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
C0451306 (UMLS CUI [4])
C0033975 (UMLS CUI [5])
C0270287 (UMLS CUI [6])
C0270288 (UMLS CUI [7])
Exclusion Medical | ECG abnormality | Hypotension | Hypotension orthostatic symptomatic | Laboratory test result abnormal | Renal Insufficiency Severe
Item
other medical exclusions, like ecg abnormalities, hypotension and/or symptomatic orthostatic hypotension, some abnormal laboratory parameters (e.g. severe renal impairment), etc
boolean
C2828389 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C1832603 (UMLS CUI [2])
C0020649 (UMLS CUI [3])
C0740482 (UMLS CUI [4])
C0438215 (UMLS CUI [5])
C1565489 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
Exclusion pharmacological | Selegiline | Antidepressive Agents Use Regular | Dopamine Antagonists | Pharmaceutical Preparations Dopamine Antagonists Containing
Item
pharmacological exclusions, e.g. selegiline within 8 weeks prior to screening visit, regular use of anti-depressant drugs, any medication with central dopaminergic antagonist activity, etc
boolean
C2828389 (UMLS CUI [1,1])
C0205464 (UMLS CUI [1,2])
C0036579 (UMLS CUI [2])
C0003289 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0205272 (UMLS CUI [3,3])
C0242702 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0242702 (UMLS CUI [5,2])
C0332256 (UMLS CUI [5,3])