ID

31463

Beskrivning

Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01168596

Länk

https://clinicaltrials.gov/show/NCT01168596

Nyckelord

Versioner (1)
  1. 2018-08-24 2018-08-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 augusti 2018

DOI

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Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT01168596

Engelsk

Eligibility Parkinson's Disease NCT01168596

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. a clinical diagnosis of idiopathic pd by a movement disorders specialist. all subjects will be diagnosed using the uk brain bank criteria (hughes et al., 1992).
Beskrivning

Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
2. age between 40-85 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. able to sign and understand informed consent; and cognitively able to carry out the procedures in the study
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
4. stable on all pd medications for at least 30 days; and psychotropic medications for at least 90 days.
Beskrivning

Antiparkinson Agents Stable | Psychotropic Drugs Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0033978
UMLS CUI [2,2]
C0205360
5. treatment naïve subjects who are appropriate candidates to begin mao-inhibitor monotherapy as treatment for their pd may also be included in this study.
Beskrivning

Study Subject Therapy naive | Under consideration Monoamine Oxidase Inhibitors Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C1272681
UMLS CUI [2,2]
C0026457
UMLS CUI [2,3]
C0030567
6. fatigue severity scale ≥ 36 (krupps et al., 1989)
Beskrivning

Fatigue Severity Scale

Datatyp

boolean

Alias
UMLS CUI [1]
C3813323
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. clinically significant medical disease that is associated independently with fatigue (e.g. significant cardiac or pulmonary disease, anemia, obstructive sleep apnea, liver or kidney failure).
Beskrivning

Disease Associated with Fatigue | Heart Diseases | Lung diseases | Anemia | Sleep Apnea, Obstructive | Liver Failure | Kidney Failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0015672
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0002871
UMLS CUI [5]
C0520679
UMLS CUI [6]
C0085605
UMLS CUI [7]
C0035078
2. history of neurological illnesses other than pd or a history of a significant head trauma (involving unconsciousness).
Beskrivning

Nervous system disorder | Exception Parkinson Disease | Craniocerebral Trauma | Unconscious State

Datatyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030567
UMLS CUI [3]
C0018674
UMLS CUI [4]
C0041657
3. evidence of secondary or atypical parkinsonism as suggested by the presence of any of the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3) history of encephalitis, 4) neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear gaze palsy, or significant orthostatic hypotension.
Beskrivning

Secondary Parkinson Disease | Atypical Parkinsonism | Cerebrovascular accident | Exposure to Toxins | Exposure to Antipsychotic Agents | Encephalitis | Neurologic Signs Upper Motor Neuron Disease | Involvement Cerebellar | Supranuclear gaze palsy | Hypotension, Orthostatic

Datatyp

boolean

Alias
UMLS CUI [1]
C0030569
UMLS CUI [2]
C4302185
UMLS CUI [3]
C0038454
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C0040549
UMLS CUI [5,1]
C0332157
UMLS CUI [5,2]
C0040615
UMLS CUI [6]
C0014038
UMLS CUI [7,1]
C0751378
UMLS CUI [7,2]
C0521659
UMLS CUI [8,1]
C1314939
UMLS CUI [8,2]
C0007765
UMLS CUI [9]
C1720037
UMLS CUI [10]
C0020651
4. mri or ct scan with significant evidence of brain atrophy or other abnormalities (e.g. lacunar infarcts or iron deposits in the putamen.
Beskrivning

Cerebral atrophy MRI | Cerebral atrophy CT scan | Abnormality of brain MRI | Abnormality of brain CT scan | Infarction, Lacunar | Iron Deposits Putamen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0235946
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C0235946
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C4021085
UMLS CUI [3,2]
C0024485
UMLS CUI [4,1]
C4021085
UMLS CUI [4,2]
C0040405
UMLS CUI [5]
C0333559
UMLS CUI [6,1]
C0302583
UMLS CUI [6,2]
C0333562
UMLS CUI [6,3]
C1281335
5. clinical diagnoses of dementia; or an mmse score of < 25.
Beskrivning

Dementia | Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0451306
6. unstable, newly diagnosed, or newly treated (i.e. less than 3 months) major psychiatric disorder such as depression or anxiety
Beskrivning

Mental disorder Major Unstable | Mental disorder Major Newly Diagnosed | Mental disorder Major Treated | Depressive disorder | Anxiety

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0443343
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C1518321
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C1522326
UMLS CUI [4]
C0011581
UMLS CUI [5]
C0003467
7. beck's depression inventory score >14.
Beskrivning

Beck depression inventory score

Datatyp

boolean

Alias
UMLS CUI [1]
C2960571
8. current or prior placement of deep brain stimulator.
Beskrivning

Deep brain stimulator implant

Datatyp

boolean

Alias
UMLS CUI [1]
C4069029
9. currently taking an mao-b inhibitor or medications which are used as fatigue treatments, including amantadine, modafinil, methylphenidate, atomoxetine or other psychostimulants.
Beskrivning

MAO-B Inhibitors | Pharmaceutical Preparations Fatigue | Amantadine | modafinil | Methylphenidate | atomoxetine | Psychostimulant

Datatyp

boolean

Alias
UMLS CUI [1]
C4020574
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0015672
UMLS CUI [3]
C0002403
UMLS CUI [4]
C0066677
UMLS CUI [5]
C0025810
UMLS CUI [6]
C0076823
UMLS CUI [7]
C0304403
10. previously taken an mao-b inhibitor for more than 2 weeks.
Beskrivning

MAO-B Inhibitors In the past

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4020574
UMLS CUI [1,2]
C1444637
11. hypersensitivity to rasagiline or its products
Beskrivning

Hypersensitivity Rasagiline

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0525678
12. on mirtazapine, venlafaxine, regular use of compounds with vasoconstrictors, tramadol, meperidine, propoxyphene, dextromethorphan, st. john's wort, cyclobenzaprine
Beskrivning

Mirtazapine | venlafaxine | Vasoconstrictor Agents Regular | Tramadol | Meperidine | Propoxyphene | Dextromethorphan | ST. JOHN'S WORT EXTRACT | cyclobenzaprine

Datatyp

boolean

Alias
UMLS CUI [1]
C0049506
UMLS CUI [2]
C0078569
UMLS CUI [3,1]
C0042397
UMLS CUI [3,2]
C0205272
UMLS CUI [4]
C0040610
UMLS CUI [5]
C0025376
UMLS CUI [6]
C0033493
UMLS CUI [7]
C0011816
UMLS CUI [8]
C0813171
UMLS CUI [9]
C0056732
13. on omeprazole, ciprofloxacin or drugs that are metabolized through cyp1a2
Beskrivning

Omeprazole | Ciprofloxacin | Pharmaceutical Preparations Metabolism CYP1A2

Datatyp

boolean

Alias
UMLS CUI [1]
C0028978
UMLS CUI [2]
C0008809
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C2698779
UMLS CUI [3,3]
C0207509
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Similar models

Eligibility Parkinson's Disease NCT01168596

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
1. a clinical diagnosis of idiopathic pd by a movement disorders specialist. all subjects will be diagnosed using the uk brain bank criteria (hughes et al., 1992).
boolean
C0030567 (UMLS CUI [1])
Age
Item
2. age between 40-85 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
3. able to sign and understand informed consent; and cognitively able to carry out the procedures in the study
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Antiparkinson Agents Stable | Psychotropic Drugs Stable
Item
4. stable on all pd medications for at least 30 days; and psychotropic medications for at least 90 days.
boolean
C0003405 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0033978 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Study Subject Therapy naive | Under consideration Monoamine Oxidase Inhibitors Parkinson Disease
Item
5. treatment naïve subjects who are appropriate candidates to begin mao-inhibitor monotherapy as treatment for their pd may also be included in this study.
boolean
C0681850 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C1272681 (UMLS CUI [2,1])
C0026457 (UMLS CUI [2,2])
C0030567 (UMLS CUI [2,3])
Fatigue Severity Scale
Item
6. fatigue severity scale ≥ 36 (krupps et al., 1989)
boolean
C3813323 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Associated with Fatigue | Heart Diseases | Lung diseases | Anemia | Sleep Apnea, Obstructive | Liver Failure | Kidney Failure
Item
1. clinically significant medical disease that is associated independently with fatigue (e.g. significant cardiac or pulmonary disease, anemia, obstructive sleep apnea, liver or kidney failure).
boolean
C0012634 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0015672 (UMLS CUI [1,3])
C0018799 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0002871 (UMLS CUI [4])
C0520679 (UMLS CUI [5])
C0085605 (UMLS CUI [6])
C0035078 (UMLS CUI [7])
Nervous system disorder | Exception Parkinson Disease | Craniocerebral Trauma | Unconscious State
Item
2. history of neurological illnesses other than pd or a history of a significant head trauma (involving unconsciousness).
boolean
C0027765 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
C0018674 (UMLS CUI [3])
C0041657 (UMLS CUI [4])
Secondary Parkinson Disease | Atypical Parkinsonism | Cerebrovascular accident | Exposure to Toxins | Exposure to Antipsychotic Agents | Encephalitis | Neurologic Signs Upper Motor Neuron Disease | Involvement Cerebellar | Supranuclear gaze palsy | Hypotension, Orthostatic
Item
3. evidence of secondary or atypical parkinsonism as suggested by the presence of any of the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3) history of encephalitis, 4) neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear gaze palsy, or significant orthostatic hypotension.
boolean
C0030569 (UMLS CUI [1])
C4302185 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0332157 (UMLS CUI [4,1])
C0040549 (UMLS CUI [4,2])
C0332157 (UMLS CUI [5,1])
C0040615 (UMLS CUI [5,2])
C0014038 (UMLS CUI [6])
C0751378 (UMLS CUI [7,1])
C0521659 (UMLS CUI [7,2])
C1314939 (UMLS CUI [8,1])
C0007765 (UMLS CUI [8,2])
C1720037 (UMLS CUI [9])
C0020651 (UMLS CUI [10])
Cerebral atrophy MRI | Cerebral atrophy CT scan | Abnormality of brain MRI | Abnormality of brain CT scan | Infarction, Lacunar | Iron Deposits Putamen
Item
4. mri or ct scan with significant evidence of brain atrophy or other abnormalities (e.g. lacunar infarcts or iron deposits in the putamen.
boolean
C0235946 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0235946 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C4021085 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
C4021085 (UMLS CUI [4,1])
C0040405 (UMLS CUI [4,2])
C0333559 (UMLS CUI [5])
C0302583 (UMLS CUI [6,1])
C0333562 (UMLS CUI [6,2])
C1281335 (UMLS CUI [6,3])
Dementia | Mini-mental state examination
Item
5. clinical diagnoses of dementia; or an mmse score of < 25.
boolean
C0497327 (UMLS CUI [1])
C0451306 (UMLS CUI [2])
Mental disorder Major Unstable | Mental disorder Major Newly Diagnosed | Mental disorder Major Treated | Depressive disorder | Anxiety
Item
6. unstable, newly diagnosed, or newly treated (i.e. less than 3 months) major psychiatric disorder such as depression or anxiety
boolean
C0004936 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C1518321 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C0011581 (UMLS CUI [4])
C0003467 (UMLS CUI [5])
Beck depression inventory score
Item
7. beck's depression inventory score >14.
boolean
C2960571 (UMLS CUI [1])
Deep brain stimulator implant
Item
8. current or prior placement of deep brain stimulator.
boolean
C4069029 (UMLS CUI [1])
MAO-B Inhibitors | Pharmaceutical Preparations Fatigue | Amantadine | modafinil | Methylphenidate | atomoxetine | Psychostimulant
Item
9. currently taking an mao-b inhibitor or medications which are used as fatigue treatments, including amantadine, modafinil, methylphenidate, atomoxetine or other psychostimulants.
boolean
C4020574 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0015672 (UMLS CUI [2,2])
C0002403 (UMLS CUI [3])
C0066677 (UMLS CUI [4])
C0025810 (UMLS CUI [5])
C0076823 (UMLS CUI [6])
C0304403 (UMLS CUI [7])
MAO-B Inhibitors In the past
Item
10. previously taken an mao-b inhibitor for more than 2 weeks.
boolean
C4020574 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Hypersensitivity Rasagiline
Item
11. hypersensitivity to rasagiline or its products
boolean
C0020517 (UMLS CUI [1,1])
C0525678 (UMLS CUI [1,2])
Mirtazapine | venlafaxine | Vasoconstrictor Agents Regular | Tramadol | Meperidine | Propoxyphene | Dextromethorphan | ST. JOHN'S WORT EXTRACT | cyclobenzaprine
Item
12. on mirtazapine, venlafaxine, regular use of compounds with vasoconstrictors, tramadol, meperidine, propoxyphene, dextromethorphan, st. john's wort, cyclobenzaprine
boolean
C0049506 (UMLS CUI [1])
C0078569 (UMLS CUI [2])
C0042397 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
C0040610 (UMLS CUI [4])
C0025376 (UMLS CUI [5])
C0033493 (UMLS CUI [6])
C0011816 (UMLS CUI [7])
C0813171 (UMLS CUI [8])
C0056732 (UMLS CUI [9])
Omeprazole | Ciprofloxacin | Pharmaceutical Preparations Metabolism CYP1A2
Item
13. on omeprazole, ciprofloxacin or drugs that are metabolized through cyp1a2
boolean
C0028978 (UMLS CUI [1])
C0008809 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C2698779 (UMLS CUI [3,2])
C0207509 (UMLS CUI [3,3])
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