Gender | Parkinson Disease Advanced | Resting Tremor | Bradykinesia | Rigidity
Item
1. male or female patient with advanced idiopathic parkinsons disease confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
boolean
C0079399 (UMLS CUI [1])
C0030567 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0234379 (UMLS CUI [3])
C0233565 (UMLS CUI [4])
C0026837 (UMLS CUI [5])
Parkinson Disease disease length
Item
2. parkinsons disease diagnosed for at least 2 years.
boolean
C0030567 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
3. patients 30 years of age or older at the time of diagnosis.
boolean
C0001779 (UMLS CUI [1])
UPDRS - Modified Hoehn and Yahr Staging
Item
4. modified hoehn and yahr stage of 2 to 4 at on-time.
boolean
C3639878 (UMLS CUI [1])
Levodopa | Combined Modality Therapy | Levodopa Controlled release | DOPA Decarboxylase Inhibitors | entacapone | Therapeutic procedure Dose Optimal Stable
Item
5. treatment with standard or controlled release levodopa combined with a dopa-decarboxylase-inhibitor, or with levodopa combined with a dopa-decarboxylase-inhibitor/entacapone, at an optimised dose according to investigators judgement, this dose being stable for at least 4 weeks prior to baseline visit.
boolean
C0023570 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0023570 (UMLS CUI [3,1])
C0868939 (UMLS CUI [3,2])
C0598272 (UMLS CUI [4])
C0165921 (UMLS CUI [5])
C0087111 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C2698651 (UMLS CUI [6,3])
C0205360 (UMLS CUI [6,4])
Motor fluctuations | Subject Diary Completed
Item
6. motor fluctuations, with at least 2 cumulative hours of off-time every day during waking hours (documented on a patient diary completed for 2 consecutive days before baseline visit).
boolean
C1868976 (UMLS CUI [1])
C3890583 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Protocol Compliance | Subject Diary Completion Able
Item
7. patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. in particular, after training, it has to be documented at baseline visit that the patient is able to recognise the off-time and on-time periods during waking hours and that the patient (or a family member or a guardian) is able to record them accurately in the patient diary.
boolean
C0525058 (UMLS CUI [1])
C3890583 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Informed Consent
Item
8. signed informed consent obtained before any study procedures are carried out (in accordance with international conference on harmonisation-good clinical practice guidelines and local legislation).
boolean
C0021430 (UMLS CUI [1])
Atypical Parkinson Disease Due to Pharmaceutical Preparations | Atypical Parkinson Disease Due to Metabolic Diseases | Atypical Parkinson Disease Due to Encephalitis | Atypical Parkinson Disease Due to Degenerative disorder
Item
1. atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
boolean
C1868596 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1868596 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0025517 (UMLS CUI [2,3])
C1868596 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0014038 (UMLS CUI [3,3])
C1868596 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C1285162 (UMLS CUI [4,3])
Dementia Mini-mental state examination
Item
2. dementia, as defined by a mini-mental state exam score < 24 at screening visit
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Mental disorder Preventing Protocol Compliance | Mental disorder Preventing Completion of clinical trial | Mental disorder At risk Patient
Item
3. any psychiatric disorder according to diagnostic and statistical manual of mental disorders 4th edition criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study
boolean
C0004936 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0030705 (UMLS CUI [3,3])
Psychotic Disorder | Exception Hallucinations Drug-induced
Item
4. history of psychosis, except history of drug induced hallucinations
boolean
C0033975 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018524 (UMLS CUI [2,2])
C0458082 (UMLS CUI [2,3])
Deep Brain Stimulation
Item
5. history of deep brain stimulation
boolean
C0394162 (UMLS CUI [1])
ECG abnormality
Item
6. clinically significant electrocardiogram abnormalities at screening visit
boolean
C0522055 (UMLS CUI [1])
Hypotension | Hypotension orthostatic symptomatic
Item
7. clinically significant hypotension and/or symptomatic orthostatic hypotension at screening or baseline visit
boolean
C0020649 (UMLS CUI [1])
C0740482 (UMLS CUI [2])
Melanoma | Prior Therapy Melanoma
Item
8. malignant melanoma or history of previously treated malignant melanoma
boolean
C0025202 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0025202 (UMLS CUI [2,2])
Disease At risk Patient | Disease Preventing Protocol Compliance | Disease Preventing Completion of clinical trial
Item
9. any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
10. pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Sexually active Contraceptive methods Lacking
Item
11. sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the screening visit and throughout the study period
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0332268 (UMLS CUI [1,4])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised | Elevated total bilirubin
Item
12. serum levels of aspartate aminotransferase (serum glutamic-oxaloacetic transaminase), alanine aminotransferase (serum glutamic pyruvic transaminase), alkaline phosphatases or bilirubin > 2 upper limit of normal
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151849 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
Creatinine clearance measurement
Item
13. patients with a creatinine clearance < 50 millilitres/minute
boolean
C0373595 (UMLS CUI [1])
Dopamine Agonists | Pramipexole
Item
14. any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit
boolean
C0178601 (UMLS CUI [1])
C0074710 (UMLS CUI [2])
Dopamine Antagonists
Item
15. any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
boolean
C0242702 (UMLS CUI [1])
Methylphenidate | Cinnarizine | Amphetamines
Item
16. any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines
boolean
C0025810 (UMLS CUI [1])
C0008803 (UMLS CUI [2])
C0002667 (UMLS CUI [3])
Flunarizine
Item
17. flunarizine within 3 months prior to baseline visit
boolean
C0016295 (UMLS CUI [1])
Hypersensitivity Pramipexole | Hypersensitivity Pramipexole Excipient
Item
18. known hypersensitivity to pramipexole or its excipients
boolean
C0020517 (UMLS CUI [1,1])
C0074710 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0074710 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Drug abuse
Item
19. drug abuse according to investigators judgement, within 2 years prior to screening
boolean
C0013146 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
20. participation in other investigational drug studies, or use of other investigational drugs within one month or five times the half-life of the investigational drug (whichever is longer) prior to baseline visit
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])