Gender | Outpatients
Item
male or female outpatients.
boolean
C0079399 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
Age
Item
age >=35 years at screening.·
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease Symptoms Quantity | Resting Tremor | Bradykinesia | Rigidity
Item
diagnosis of parkinson's syndrome, on at least two of the three key parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity.
boolean
C0030567 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0234379 (UMLS CUI [2])
C0233565 (UMLS CUI [3])
C0026837 (UMLS CUI [4])
disease length
Item
duration of the disease of less than 3 years since diagnosis·
boolean
C0872146 (UMLS CUI [1])
UPDRS - Modified Hoehn and Yahr Staging
Item
modified hoehn and yahr stage <= 2.5.
boolean
C3639878 (UMLS CUI [1])
Patients untreated
Item
untreated patients.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
General health good | Ambulatory
Item
generally healthy and ambulatory.
boolean
C1277245 (UMLS CUI [1])
C0439841 (UMLS CUI [2])
Informed Consent | Protocol Compliance
Item
patient has given his informed written consent and is capable of following study procedures.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Indication Parkinsonian Disorders | Parkinson Disease
Item
any indication of forms of parkinsonism other than pd.
boolean
C3146298 (UMLS CUI [1,1])
C0242422 (UMLS CUI [1,2])
C0030567 (UMLS CUI [2])
Resting Tremor Severe
Item
severe resting tremor.
boolean
C0234379 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Dyskinetic syndrome | Motor fluctuations | Postural reflex Loss
Item
presence of either dyskinesia, fluctuations, or loss of postural reflexes·
boolean
C0013384 (UMLS CUI [1])
C1868976 (UMLS CUI [2])
C0234154 (UMLS CUI [3,1])
C1517945 (UMLS CUI [3,2])
Levodopa | Dopamine Agonists | Amantadine | Anticholinergic Agents | Catechol-O-methyltransferase inhibitor | Selegiline | Dopamine Antagonists | catecholamine inhibitor | Dopamine Agonists Indirect | Methyldopa
Item
treatment with l-dopa, dopamine agonist, amantadine, anticholinergics, catechol-o-methyltransferase (comt ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa.
boolean
C0023570 (UMLS CUI [1])
C0178601 (UMLS CUI [2])
C0002403 (UMLS CUI [3])
C0242896 (UMLS CUI [4])
C0595267 (UMLS CUI [5])
C0036579 (UMLS CUI [6])
C0242702 (UMLS CUI [7])
C0596280 (UMLS CUI [8])
C0178601 (UMLS CUI [9,1])
C0439852 (UMLS CUI [9,2])
C0025741 (UMLS CUI [10])
Electroconvulsive Therapy
Item
electroconvulsive therapy (ect).
boolean
C0013806 (UMLS CUI [1])
CYP3A4 Inducers Strong | CYP3A4 Inducers Moderate | CYP3A4 Inhibitors Strong | CYP3A4 Inhibitors Moderate
Item
use of cyp3a4 strong, and moderate inducers or inhibitors.
boolean
C3850041 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850041 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3850053 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C3850053 (UMLS CUI [4,1])
C0205081 (UMLS CUI [4,2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in another clinical trial with an investigational drug within two months prior to randomization.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Dementia | Depressive disorder Uncontrolled | Psychotic Disorder
Item
dementia, uncontrolled depression, psychotic disorder.
boolean
C0497327 (UMLS CUI [1])
C0011581 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0033975 (UMLS CUI [3])
Substance Use Disorders
Item
history of substance-related disorders including alcohol or other substance use disorders.
boolean
C0038586 (UMLS CUI [1])
Childbearing Potential
Item
females of child bearing potential.
boolean
C3831118 (UMLS CUI [1])
Disease Clinical Significance Interferes with Study Subject Participation Status | Disease Unstable Interferes with Study Subject Participation Status | Medical History | Physical Examination | Laboratory Tests | ECG finding | Disease Unstable Interferes with Investigational New Drug absorption | Disease Unstable Interferes with Investigational New Drug metabolism | Disease Unstable Interferes with Investigational New Drug excretion | Disease Unstable Interferes with Investigational New Drug Evaluation
Item
evidence (detected by history, physical examination and/or laboratory/ecg tests) of any clinically significant or unstable medical disorder that could interfere with the patient's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug.
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0262926 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C0022885 (UMLS CUI [5])
C0438154 (UMLS CUI [6])
C0012634 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0521102 (UMLS CUI [7,3])
C0013230 (UMLS CUI [7,4])
C0678745 (UMLS CUI [7,5])
C0012634 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0521102 (UMLS CUI [8,3])
C0013230 (UMLS CUI [8,4])
C0025520 (UMLS CUI [8,5])
C0012634 (UMLS CUI [9,1])
C0443343 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C0013230 (UMLS CUI [9,4])
C0683141 (UMLS CUI [9,5])
C0012634 (UMLS CUI [10,1])
C0443343 (UMLS CUI [10,2])
C0521102 (UMLS CUI [10,3])
C0013230 (UMLS CUI [10,4])
C1261322 (UMLS CUI [10,5])
Laboratory Tests Alteration | ECG finding Clinical Significance potential
Item
alterations of laboratory tests or ecg findings of potential clinical significance.
boolean
C0022885 (UMLS CUI [1,1])
C1515926 (UMLS CUI [1,2])
C0438154 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C3245505 (UMLS CUI [2,3])