ID

42749

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00466167

Trefwoorden

Versies (2)
  1. 21/08/2017 21/08/2017 -
  2. 17/09/2021 17/09/2021 -
Geüploaded op

17 septembre 2021

DOI

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Licentie

Creative Commons BY 4.0
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    Eligibility Parkinson Disease NCT00466167

    Engels

    Eligibility Parkinson Disease NCT00466167

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    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.
    Beschrijving

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

    Datatype

    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.
    Beschrijving

    Parkinson Disease disease length

    Datatype

    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.
    Beschrijving

    Age

    Datatype

    boolean

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

    UPDRS - Modified Hoehn and Yahr Staging

    Datatype

    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.
    Beschrijving

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

    Datatype

    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).
    Beschrijving

    Motor fluctuations | Subject Diary Completed

    Datatype

    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.
    Beschrijving

    Protocol Compliance | Subject Diary Completion Able

    Datatype

    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).
    Beschrijving

    Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

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

    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

    Datatype

    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
    Beschrijving

    Dementia Mini-mental state examination

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Psychotic Disorder | Exception Hallucinations Drug-induced

    Datatype

    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
    Beschrijving

    Deep Brain Stimulation

    Datatype

    boolean

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

    ECG abnormality

    Datatype

    boolean

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

    Hypotension | Hypotension orthostatic symptomatic

    Datatype

    boolean

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

    Melanoma | Prior Therapy Melanoma

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Pregnancy | Breast Feeding

    Datatype

    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
    Beschrijving

    Childbearing Potential Sexually active Contraceptive methods Lacking

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Creatinine clearance measurement

    Datatype

    boolean

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

    Dopamine Agonists | Pramipexole

    Datatype

    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
    Beschrijving

    Dopamine Antagonists

    Datatype

    boolean

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

    Methylphenidate | Cinnarizine | Amphetamines

    Datatype

    boolean

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

    Flunarizine

    Datatype

    boolean

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

    Hypersensitivity Pramipexole | Hypersensitivity Pramipexole Excipient

    Datatype

    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
    Beschrijving

    Drug abuse

    Datatype

    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
    Beschrijving

    Study Subject Participation Status | Investigational New Drugs

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0013230
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    Similar models

    Eligibility Parkinson Disease NCT00466167

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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