ID

42749

Beschreibung

Pivotal Study in Advanced Parkinsons Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00466167

Link

https://clinicaltrials.gov/show/NCT00466167

Stichworte

Versionen (2)
  1. 21.08.17 21.08.17 -
  2. 17.09.21 17.09.21 -
Hochgeladen am

17. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00466167

Englisch

Eligibility Parkinson Disease NCT00466167

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patient with advanced idiopathic parkinsons disease confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
Beschreibung

Gender | Parkinson Disease Advanced | Resting Tremor | Bradykinesia | Rigidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0030567
UMLS CUI [2,2]
C0205179
UMLS CUI [3]
C0234379
UMLS CUI [4]
C0233565
UMLS CUI [5]
C0026837
2. parkinsons disease diagnosed for at least 2 years.
Beschreibung

Parkinson Disease disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0872146
3. patients 30 years of age or older at the time of diagnosis.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. modified hoehn and yahr stage of 2 to 4 at on-time.
Beschreibung

UPDRS - Modified Hoehn and Yahr Staging

Datentyp

boolean

Alias
UMLS CUI [1]
C3639878
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.
Beschreibung

Levodopa | Combined Modality Therapy | Levodopa Controlled release | DOPA Decarboxylase Inhibitors | entacapone | Therapeutic procedure Dose Optimal Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0009429
UMLS CUI [3,1]
C0023570
UMLS CUI [3,2]
C0868939
UMLS CUI [4]
C0598272
UMLS CUI [5]
C0165921
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C2698651
UMLS CUI [6,4]
C0205360
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).
Beschreibung

Motor fluctuations | Subject Diary Completed

Datentyp

boolean

Alias
UMLS CUI [1]
C1868976
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0205197
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.
Beschreibung

Protocol Compliance | Subject Diary Completion Able

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0085732
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).
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868596
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C1868596
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0025517
UMLS CUI [3,1]
C1868596
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0014038
UMLS CUI [4,1]
C1868596
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C1285162
2. dementia, as defined by a mini-mental state exam score < 24 at screening visit
Beschreibung

Dementia Mini-mental state examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
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
Beschreibung

Mental disorder Preventing Protocol Compliance | Mental disorder Preventing Completion of clinical trial | Mental disorder At risk Patient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0030705
4. history of psychosis, except history of drug induced hallucinations
Beschreibung

Psychotic Disorder | Exception Hallucinations Drug-induced

Datentyp

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018524
UMLS CUI [2,3]
C0458082
5. history of deep brain stimulation
Beschreibung

Deep Brain Stimulation

Datentyp

boolean

Alias
UMLS CUI [1]
C0394162
6. clinically significant electrocardiogram abnormalities at screening visit
Beschreibung

ECG abnormality

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
7. clinically significant hypotension and/or symptomatic orthostatic hypotension at screening or baseline visit
Beschreibung

Hypotension | Hypotension orthostatic symptomatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0740482
8. malignant melanoma or history of previously treated malignant melanoma
Beschreibung

Melanoma | Prior Therapy Melanoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0025202
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0025202
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
Beschreibung

Disease At risk Patient | Disease Preventing Protocol Compliance | Disease Preventing Completion of clinical trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0030705
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C2732579
10. pregnancy or breast-feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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
Beschreibung

Childbearing Potential Sexually active Contraceptive methods Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C0332268
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
Beschreibung

Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised | Elevated total bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151849
UMLS CUI [4]
C0741494
13. patients with a creatinine clearance < 50 millilitres/minute
Beschreibung

Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
14. any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit
Beschreibung

Dopamine Agonists | Pramipexole

Datentyp

boolean

Alias
UMLS CUI [1]
C0178601
UMLS CUI [2]
C0074710
15. any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
Beschreibung

Dopamine Antagonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0242702
16. any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines
Beschreibung

Methylphenidate | Cinnarizine | Amphetamines

Datentyp

boolean

Alias
UMLS CUI [1]
C0025810
UMLS CUI [2]
C0008803
UMLS CUI [3]
C0002667
17. flunarizine within 3 months prior to baseline visit
Beschreibung

Flunarizine

Datentyp

boolean

Alias
UMLS CUI [1]
C0016295
18. known hypersensitivity to pramipexole or its excipients
Beschreibung

Hypersensitivity Pramipexole | Hypersensitivity Pramipexole Excipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0074710
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0074710
UMLS CUI [2,3]
C0015237
19. drug abuse according to investigators judgement, within 2 years prior to screening
Beschreibung

Drug abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0013146
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
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Ähnliche Modelle

Eligibility Parkinson Disease NCT00466167

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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