ID

31395

Beskrivning

Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00438607

Länk

https://clinicaltrials.gov/show/NCT00438607

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 NCT00438607

Engelsk

Eligibility Parkinson's Disease NCT00438607

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
must carry a diagnosis of idiopathic pd according to uk parkinson's disease society brain bank clinical diagnostic criteria, and be hoehn & yahr stage ii to iv (inclusive) when off.
Beskrivning

Parkinson Disease Hoehn and Yahr Stage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C3639483
must be on a stable dose of l-3,4-dihydroxyphenylalanine (l-dopa)/carbidopa or l-dopa/benserazide for at least 4 weeks prior to enrollment.
Beskrivning

Carbidopa / Levodopa Dose Stable | Benserazide / Levodopa Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0353697
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0358787
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
except for l-dopa and certain allowed dopamine agonists, must not be receiving any other pd medications. (current treatment with certain dopamine agonists is allowed but subjects must have been on a stable dose for at least 4 weeks prior to enrollment).
Beskrivning

Other Antiparkinson Agents Absent | Exception Levodopa | Exception Dopamine Agonists allowed | Dopamine Agonists Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1579414
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023570
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0178601
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0178601
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
some subjects must demonstrate a definite end of l-dopa dose wearing off (at least 2 hours off time per waking day) and must be able to keep accurate patient diaries of pd activity.
Beskrivning

Levodopa Dose Wearing off effect Discontinued | Subject Diary Parkinson Disease Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1504539
UMLS CUI [1,4]
C1444662
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0030567
UMLS CUI [2,3]
C0205197
major exclusion criteria:
Beskrivning

Exclusion Criteria Major

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205164
a mini mental state examination (mmse) score <26.
Beskrivning

Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0451306
history or clinical features consistent with an atypical parkinsonian syndrome.
Beskrivning

Feature Clinical Consistent with Atypical Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348519
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0332290
UMLS CUI [1,4]
C1868596
any significant non-parkinson's central nervous system disorder.
Beskrivning

CNS disorder | Exception Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030567
any significant axis i psychiatric disease from the diagnostic and statistical manual of mental disorders (dsm).
Beskrivning

Axis I diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0270287
any previous surgical intervention for parkinson's disease.
Beskrivning

Operative Surgical Procedures Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0030567
history of certain malignancies.
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
history of severe allergic anaphylactic reactions to any drug.
Beskrivning

Anaphylaxis Severe Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0013227
clinically significant baseline electrocardiogram (ecg).
Beskrivning

Electrocardiography Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2826293
orthostatic hypotension.
Beskrivning

Hypotension, Orthostatic

Datatyp

boolean

Alias
UMLS CUI [1]
C0020651
hba1c >7.0%
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
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Similar models

Eligibility Parkinson's Disease NCT00438607

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease Hoehn and Yahr Stage
Item
must carry a diagnosis of idiopathic pd according to uk parkinson's disease society brain bank clinical diagnostic criteria, and be hoehn & yahr stage ii to iv (inclusive) when off.
boolean
C0030567 (UMLS CUI [1,1])
C3639483 (UMLS CUI [1,2])
Carbidopa / Levodopa Dose Stable | Benserazide / Levodopa Dose Stable
Item
must be on a stable dose of l-3,4-dihydroxyphenylalanine (l-dopa)/carbidopa or l-dopa/benserazide for at least 4 weeks prior to enrollment.
boolean
C0353697 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0358787 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Other Antiparkinson Agents Absent | Exception Levodopa | Exception Dopamine Agonists allowed | Dopamine Agonists Dose Stable
Item
except for l-dopa and certain allowed dopamine agonists, must not be receiving any other pd medications. (current treatment with certain dopamine agonists is allowed but subjects must have been on a stable dose for at least 4 weeks prior to enrollment).
boolean
C1579414 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0023570 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0178601 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0178601 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Levodopa Dose Wearing off effect Discontinued | Subject Diary Parkinson Disease Completion
Item
some subjects must demonstrate a definite end of l-dopa dose wearing off (at least 2 hours off time per waking day) and must be able to keep accurate patient diaries of pd activity.
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1504539 (UMLS CUI [1,3])
C1444662 (UMLS CUI [1,4])
C3890583 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Exclusion Criteria Major
Item
major exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Mini-mental state examination
Item
a mini mental state examination (mmse) score <26.
boolean
C0451306 (UMLS CUI [1])
Feature Clinical Consistent with Atypical Parkinson Disease
Item
history or clinical features consistent with an atypical parkinsonian syndrome.
boolean
C2348519 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C1868596 (UMLS CUI [1,4])
CNS disorder | Exception Parkinson Disease
Item
any significant non-parkinson's central nervous system disorder.
boolean
C0007682 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
Axis I diagnosis
Item
any significant axis i psychiatric disease from the diagnostic and statistical manual of mental disorders (dsm).
boolean
C0270287 (UMLS CUI [1])
Operative Surgical Procedures Parkinson Disease
Item
any previous surgical intervention for parkinson's disease.
boolean
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Malignant Neoplasms
Item
history of certain malignancies.
boolean
C0006826 (UMLS CUI [1])
Anaphylaxis Severe Pharmaceutical Preparations
Item
history of severe allergic anaphylactic reactions to any drug.
boolean
C0002792 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Electrocardiography Clinical Significance
Item
clinically significant baseline electrocardiogram (ecg).
boolean
C1623258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hypotension, Orthostatic
Item
orthostatic hypotension.
boolean
C0020651 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c >7.0%
boolean
C0474680 (UMLS CUI [1])
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