ID

22336

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00199355

Palabras clave

Versiones (1)
  1. 30/5/17 30/5/17 -
Subido en

30 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00199355

Inglés

Eligibility Parkinson's Disease NCT00199355

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Parkinson Disease

Tipo de datos

boolean

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

Parkinson Disease Modified Hoehn and Yahr Staging

Tipo de datos

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.
Descripción

Levodopa Dose Stable | Decarboxylase inhibitor Dose Stable

Tipo de datos

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.
Descripción

Levodopa Dose Quantity Daily | Decarboxylase inhibitor Dose Quantity Daily

Tipo de datos

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.
Descripción

Dose Wearing off End Expected

Tipo de datos

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.
Descripción

Parkinson Disease Subject Diary Completion

Tipo de datos

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.
Descripción

Subject Diary Timing

Tipo de datos

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.
Descripción

Pharmaceutical Preparations Stable Parkinson Disease

Tipo de datos

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.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descripción

Exclusion Criteria

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

Neurosurgical Procedures Parkinson Disease

Tipo de datos

boolean

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

Psychotic Disorders

Tipo de datos

boolean

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

Atypical Parkinson Disease | Secondary parkinsonism

Tipo de datos

boolean

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

Malignant Neoplasms

Tipo de datos

boolean

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

Illness Organ system

Tipo de datos

boolean

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

Mini-mental state examination score

Tipo de datos

boolean

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

Intake Pharmaceutical Preparations Excluded

Tipo de datos

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.
Descripción

Substance Use Disorders | Substance Dependence

Tipo de datos

boolean

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

Seizures | malignant neosplasm of the neurological system

Tipo de datos

boolean

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

clinical depression

Tipo de datos

boolean

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

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Eligibility Parkinson's Disease NCT00199355

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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