ID

22336

Beskrivning

A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa; ODM derived from: https://clinicaltrials.gov/show/NCT00199355

Länk

https://clinicaltrials.gov/show/NCT00199355

Nyckelord

Versioner (1)
  1. 2017-05-30 2017-05-30 -
Uppladdad den

30 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00199355

Engelsk

Eligibility Parkinson's Disease NCT00199355

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. uk parkinson's disease society (ukpds) brain bank criteria (step 1 and 2) for pd.
Beskrivning

Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
2. pd stages 2-4 in the off state for modified hoehn and yahr scale.
Beskrivning

Parkinson Disease Modified Hoehn and Yahr Staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C3639878
3. on levodopa/dci for at least one year, stable dose in past 4 weeks.
Beskrivning

Levodopa Dose Stable | Decarboxylase inhibitor Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0360140
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
4. currently take at least three doses of levodopa/dci per day.
Beskrivning

Levodopa Dose Quantity Daily | Decarboxylase inhibitor Dose Quantity Daily

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0332173
UMLS CUI [2,1]
C0360140
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0332173
5. predictable end of dose wearing off.
Beskrivning

Dose Wearing off End Expected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1504539
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C1517001
6. able to satisfactorily complete hauser version of a parkinson's diary.
Beskrivning

Parkinson Disease Subject Diary Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C3890583
UMLS CUI [1,3]
C0205197
7. have an average of 120 minutes of off time on two 24 hour diaries.
Beskrivning

Subject Diary Timing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0449243
8. on a stable regimen of medications being administered within normal therapeutic limits for parkinson's disease for at least four weeks before randomization.
Beskrivning

Pharmaceutical Preparations Stable Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0030567
9. be at least 30 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. neurosurgical treatment for pd.
Beskrivning

Neurosurgical Procedures Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524850
UMLS CUI [1,2]
C0030567
2. history of psychosis.
Beskrivning

Psychotic Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0033975
3. diagnosis of atypical parkinsonism or secondary parkinsonism variant.
Beskrivning

Atypical Parkinson Disease | Secondary parkinsonism

Datatyp

boolean

Alias
UMLS CUI [1]
C1868596
UMLS CUI [2]
C0477357
4. diagnosis of cancer within 5 years.
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
5. diagnosis of clinically significant illness of any organ system.
Beskrivning

Illness Organ system

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0460002
6. mini-mental status examination score of 25 or less.
Beskrivning

Mini-mental state examination score

Datatyp

boolean

Alias
UMLS CUI [1]
C2960235
7. taking any excluded medications.
Beskrivning

Intake Pharmaceutical Preparations Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C2828389
8. history of drug or alcohol abuse or dependence within the past two years.
Beskrivning

Substance Use Disorders | Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
9. history of seizures or neurological malignant syndrome.
Beskrivning

Seizures | malignant neosplasm of the neurological system

Datatyp

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0848182
10. clinical depression.
Beskrivning

clinical depression

Datatyp

boolean

Alias
UMLS CUI [1]
C2362914
11. pregnant or lactating females.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Parkinson's Disease NCT00199355

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
1. uk parkinson's disease society (ukpds) brain bank criteria (step 1 and 2) for pd.
boolean
C0030567 (UMLS CUI [1])
Parkinson Disease Modified Hoehn and Yahr Staging
Item
2. pd stages 2-4 in the off state for modified hoehn and yahr scale.
boolean
C0030567 (UMLS CUI [1,1])
C3639878 (UMLS CUI [1,2])
Levodopa Dose Stable | Decarboxylase inhibitor Dose Stable
Item
3. on levodopa/dci for at least one year, stable dose in past 4 weeks.
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0360140 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Levodopa Dose Quantity Daily | Decarboxylase inhibitor Dose Quantity Daily
Item
4. currently take at least three doses of levodopa/dci per day.
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
C0360140 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0332173 (UMLS CUI [2,4])
Dose Wearing off End Expected
Item
5. predictable end of dose wearing off.
boolean
C0178602 (UMLS CUI [1,1])
C1504539 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C1517001 (UMLS CUI [1,4])
Parkinson Disease Subject Diary Completion
Item
6. able to satisfactorily complete hauser version of a parkinson's diary.
boolean
C0030567 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Subject Diary Timing
Item
7. have an average of 120 minutes of off time on two 24 hour diaries.
boolean
C3890583 (UMLS CUI [1,1])
C0449243 (UMLS CUI [1,2])
Pharmaceutical Preparations Stable Parkinson Disease
Item
8. on a stable regimen of medications being administered within normal therapeutic limits for parkinson's disease for at least four weeks before randomization.
boolean
C0013227 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Age
Item
9. be at least 30 years of age.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neurosurgical Procedures Parkinson Disease
Item
1. neurosurgical treatment for pd.
boolean
C0524850 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Psychotic Disorders
Item
2. history of psychosis.
boolean
C0033975 (UMLS CUI [1])
Atypical Parkinson Disease | Secondary parkinsonism
Item
3. diagnosis of atypical parkinsonism or secondary parkinsonism variant.
boolean
C1868596 (UMLS CUI [1])
C0477357 (UMLS CUI [2])
Malignant Neoplasms
Item
4. diagnosis of cancer within 5 years.
boolean
C0006826 (UMLS CUI [1])
Illness Organ system
Item
5. diagnosis of clinically significant illness of any organ system.
boolean
C0221423 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
Mini-mental state examination score
Item
6. mini-mental status examination score of 25 or less.
boolean
C2960235 (UMLS CUI [1])
Intake Pharmaceutical Preparations Excluded
Item
7. taking any excluded medications.
boolean
C1512806 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
Substance Use Disorders | Substance Dependence
Item
8. history of drug or alcohol abuse or dependence within the past two years.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Seizures | malignant neosplasm of the neurological system
Item
9. history of seizures or neurological malignant syndrome.
boolean
C0036572 (UMLS CUI [1])
C0848182 (UMLS CUI [2])
clinical depression
Item
10. clinical depression.
boolean
C2362914 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
11. pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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