ID

31407

Description

A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa; ODM derived from: https://clinicaltrials.gov/show/NCT00455507

Link

https://clinicaltrials.gov/show/NCT00455507

Keywords

Versions (1)
  1. 8/19/18 8/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 19, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Parkinson's Disease NCT00455507

English

Eligibility Parkinson's Disease NCT00455507

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Parkinson Disease

Data type

boolean

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

Parkinson Disease Modified Hoehn and Yahr Scale score

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C4274318
3. on levodopa/dopa-decarboxylase inhibitor for at least one year.
Description

Levodopa | DOPA Decarboxylase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0598272
4. taking at least three doses and >=300mg of levodopa per day for at least four weeks before randomization.
Description

Levodopa Dose Quantity U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0456683
5. predictable end of dose wearing off.
Description

Dose Wearing off effect End Expected

Data type

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 based 24-hour patient parkinson's diary.
Description

Subject Diary Parkinson Disease Completion | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0030567
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C3846158
7. have an average of two hours of off time on 24-hour diaries.
Description

Off Treatment Time Period Average | Subject Diary Hour Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C1948053
UMLS CUI [1,3]
C1510992
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0439227
UMLS CUI [2,3]
C1265611
8. on a stable regimen of any other anti-parkinson's drugs for at least four weeks before randomization.
Description

Other Antiparkinson Agents Regimen Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C1579414
UMLS CUI [1,2]
C0040808
UMLS CUI [1,3]
C0205360
9. be at least 20 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
10. be willing and able to give written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. taking any excluded medications.
Description

Pharmaceutical Preparations Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332196
2. neurosurgical treatment or transcranial magnetic stimulation for pd.
Description

Neurosurgical Procedures Parkinson Disease | Transcranial magnetic stimulation Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0524850
UMLS CUI [1,2]
C0030567
UMLS CUI [2,1]
C0436548
UMLS CUI [2,2]
C0030567
3. diagnosis of cancer within 5 years.
Description

Malignant Neoplasms

Data type

boolean

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

Organ system Illness

Data type

boolean

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C0221423
5. diagnosis of dementia or mini-mental status examination score of 25 or less.
Description

Dementia | Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0451306
6. history of drug or alcohol abuse or dependence within the past two years.
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
7. history of psychosis.
Description

Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0033975
8. significant drug allergies.
Description

Drug Allergy

Data type

boolean

Alias
UMLS CUI [1]
C0013182
9. taking anticonvulsants for seizures.
Description

Anticonvulsants Seizures

Data type

boolean

Alias
UMLS CUI [1,1]
C0003286
UMLS CUI [1,2]
C0036572
10. history of neurological malignant syndrome.
Description

Malignant syndrome Neurologic

Data type

boolean

Alias
UMLS CUI [1,1]
C0948281
UMLS CUI [1,2]
C0205494
11. pregnant or lactating females.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Back to the top of the page

Similar models

Eligibility Parkinson's Disease NCT00455507

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 Scale score
Item
2. pd stages 2-4 in the off state for modified hoehn and yahr scale.
boolean
C0030567 (UMLS CUI [1,1])
C4274318 (UMLS CUI [1,2])
Levodopa | DOPA Decarboxylase Inhibitors
Item
3. on levodopa/dopa-decarboxylase inhibitor for at least one year.
boolean
C0023570 (UMLS CUI [1])
C0598272 (UMLS CUI [2])
Levodopa Dose Quantity U/day
Item
4. taking at least three doses and >=300mg of levodopa per day for at least four weeks before randomization.
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Dose Wearing off effect 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])
Subject Diary Parkinson Disease Completion | Other Coding
Item
6. able to satisfactorily complete hauser based 24-hour patient parkinson's diary.
boolean
C3890583 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Off Treatment Time Period Average | Subject Diary Hour Quantity
Item
7. have an average of two hours of off time on 24-hour diaries.
boolean
C1518544 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C3890583 (UMLS CUI [2,1])
C0439227 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Other Antiparkinson Agents Regimen Stable
Item
8. on a stable regimen of any other anti-parkinson's drugs for at least four weeks before randomization.
boolean
C1579414 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Age
Item
9. be at least 20 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
10. be willing and able to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Excluded
Item
1. taking any excluded medications.
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Neurosurgical Procedures Parkinson Disease | Transcranial magnetic stimulation Parkinson Disease
Item
2. neurosurgical treatment or transcranial magnetic stimulation for pd.
boolean
C0524850 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0436548 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
Malignant Neoplasms
Item
3. diagnosis of cancer within 5 years.
boolean
C0006826 (UMLS CUI [1])
Organ system Illness
Item
4. diagnosis of clinically significant illness of any organ system.
boolean
C0460002 (UMLS CUI [1,1])
C0221423 (UMLS CUI [1,2])
Dementia | Mini-mental state examination
Item
5. diagnosis of dementia or mini-mental status examination score of 25 or less.
boolean
C0497327 (UMLS CUI [1])
C0451306 (UMLS CUI [2])
Substance Use Disorders | Substance Dependence
Item
6. history of drug or alcohol abuse or dependence within the past two years.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Psychotic Disorders
Item
7. history of psychosis.
boolean
C0033975 (UMLS CUI [1])
Drug Allergy
Item
8. significant drug allergies.
boolean
C0013182 (UMLS CUI [1])
Anticonvulsants Seizures
Item
9. taking anticonvulsants for seizures.
boolean
C0003286 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
Malignant syndrome Neurologic
Item
10. history of neurological malignant syndrome.
boolean
C0948281 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
11. pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial