ID

31407

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00455507

Nyckelord

Versioner (1)
  1. 2018-08-19 2018-08-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 augusti 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00455507

Engelsk

Eligibility Parkinson's Disease NCT00455507

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 Scale score

Datatyp

boolean

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

Levodopa | DOPA Decarboxylase Inhibitors

Datatyp

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.
Beskrivning

Levodopa Dose Quantity U/day

Datatyp

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.
Beskrivning

Dose Wearing off effect 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 based 24-hour patient parkinson's diary.
Beskrivning

Subject Diary Parkinson Disease Completion | Other Coding

Datatyp

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.
Beskrivning

Off Treatment Time Period Average | Subject Diary Hour Quantity

Datatyp

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.
Beskrivning

Other Antiparkinson Agents Regimen Stable

Datatyp

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.
Beskrivning

Age

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Pharmaceutical Preparations Excluded

Datatyp

boolean

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

Neurosurgical Procedures Parkinson Disease | Transcranial magnetic stimulation Parkinson Disease

Datatyp

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.
Beskrivning

Malignant Neoplasms

Datatyp

boolean

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

Organ system Illness

Datatyp

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.
Beskrivning

Dementia | Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0451306
6. 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
7. history of psychosis.
Beskrivning

Psychotic Disorders

Datatyp

boolean

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

Drug Allergy

Datatyp

boolean

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

Anticonvulsants Seizures

Datatyp

boolean

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

Malignant syndrome Neurologic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948281
UMLS CUI [1,2]
C0205494
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 NCT00455507

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 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])
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