ID

31399

Description

Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00442780

Link

https://clinicaltrials.gov/show/NCT00442780

Keywords

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

See clinicaltrials.gov

Uploaded on

August 19, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00442780

English

Eligibility Parkinson's Disease NCT00442780

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must give written informed consent and any authorizations required by local law.
Description

Informed Consent | Patient authorization

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0680281
must carry a diagnosis of idiopathic parkinson's disease(pd), without any other known or suspected cause of parkinsonism, according to the uk parkinson's disease society brain bank clinical diagnostic criteria. initial diagnosis of pd must have been made within the 5 years prior to screening with at least two or more of the following cardinal signs being present: bradykinesia, resting tremor, rigidity, and postural instability.
Description

Parkinson Disease Disease length | Absence Cause Other Parkinsonism | Signs Main Quantity | Bradykinesia | Resting Tremor | Muscle Rigidity | Postural instability

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C0242422
UMLS CUI [3,1]
C0311392
UMLS CUI [3,2]
C1542147
UMLS CUI [3,3]
C1265611
UMLS CUI [4]
C0233565
UMLS CUI [5]
C0234379
UMLS CUI [6]
C0026837
UMLS CUI [7]
C1843921
must be modified hoehn & yahr stage 1 to 2.5 (inclusive).
Description

Modified Hoehn and Yahr Staging

Data type

boolean

Alias
UMLS CUI [1]
C3639878
must have a baseline updrs (part iii) motor score of at least 10.
Description

UPDRS Motor Score

Data type

boolean

Alias
UMLS CUI [1,1]
C3639721
UMLS CUI [1,2]
C0682711
UMLS CUI [1,3]
C0449820
subjects may be receiving an anticholinergic agent and/or mao-b inhibitor (if they have been on a stable dose of that medication for at least 4 weeks prior to study entry) but must not be receiving any other pd medication.
Description

Anticholinergic Agents Dose Stable | MAO-B Inhibitor Dose Stable | Other Antiparkinson Agents Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0242896
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C2917433
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C1579414
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a mini mental state examination (mmse) score <26.
Description

Mini-mental state examination

Data type

boolean

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

Feature Clinical Consistent with Atypical Parkinson Disease

Data type

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-pd central nervous system disorder.
Description

CNS disorder | Exception Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030567
any significant axis i psychiatric disease as defined by the diagnostic and statistical manual of mental disorders.
Description

Axis I diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0270287
history of cognitive or neuropsychiatric conditions.
Description

Cognition Disorders | Neuropsychiatric syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0009241
UMLS CUI [2]
C3203509
history of surgical intervention for pd.
Description

Operative Surgical Procedures Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0030567
history of l-dopa-induced motor or non-motor complication.
Description

Motor Complication Levodopa Induced | Complication Levodopa Induced

Data type

boolean

Alias
UMLS CUI [1,1]
C0682711
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0023570
UMLS CUI [1,4]
C0205263
UMLS CUI [2,1]
C0009566
UMLS CUI [2,2]
C0023570
UMLS CUI [2,3]
C0205263
history of malignancy.
Description

Malignant Neoplasms

Data type

boolean

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

Allergic Reaction Severe Pharmaceutical Preparations | Anaphylaxis Severe Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0013227
clinically significant renal dysfunction.
Description

Renal dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C3279454
hba1c >7.0%.
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
clinically significant baseline ecg.
Description

Electrocardiography Clinical Significance

Data type

boolean

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

Hypotension, Orthostatic

Data type

boolean

Alias
UMLS CUI [1]
C0020651
treatment with l-dopa/carbidopa or l-dopa/benserazide for more than 6 cumulative months at anytime since subject's initial pd diagnosis.
Description

Carbidopa / Levodopa | Benserazide / Levodopa

Data type

boolean

Alias
UMLS CUI [1]
C0353697
UMLS CUI [2]
C0358787
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Similar models

Eligibility Parkinson's Disease NCT00442780

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Patient authorization
Item
must give written informed consent and any authorizations required by local law.
boolean
C0021430 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0680281 (UMLS CUI [2,2])
Parkinson Disease Disease length | Absence Cause Other Parkinsonism | Signs Main Quantity | Bradykinesia | Resting Tremor | Muscle Rigidity | Postural instability
Item
must carry a diagnosis of idiopathic parkinson's disease(pd), without any other known or suspected cause of parkinsonism, according to the uk parkinson's disease society brain bank clinical diagnostic criteria. initial diagnosis of pd must have been made within the 5 years prior to screening with at least two or more of the following cardinal signs being present: bradykinesia, resting tremor, rigidity, and postural instability.
boolean
C0030567 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0242422 (UMLS CUI [2,4])
C0311392 (UMLS CUI [3,1])
C1542147 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0233565 (UMLS CUI [4])
C0234379 (UMLS CUI [5])
C0026837 (UMLS CUI [6])
C1843921 (UMLS CUI [7])
Modified Hoehn and Yahr Staging
Item
must be modified hoehn & yahr stage 1 to 2.5 (inclusive).
boolean
C3639878 (UMLS CUI [1])
UPDRS Motor Score
Item
must have a baseline updrs (part iii) motor score of at least 10.
boolean
C3639721 (UMLS CUI [1,1])
C0682711 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Anticholinergic Agents Dose Stable | MAO-B Inhibitor Dose Stable | Other Antiparkinson Agents Absent
Item
subjects may be receiving an anticholinergic agent and/or mao-b inhibitor (if they have been on a stable dose of that medication for at least 4 weeks prior to study entry) but must not be receiving any other pd medication.
boolean
C0242896 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C2917433 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C1579414 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
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-pd 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 as defined by the diagnostic and statistical manual of mental disorders.
boolean
C0270287 (UMLS CUI [1])
Cognition Disorders | Neuropsychiatric syndrome
Item
history of cognitive or neuropsychiatric conditions.
boolean
C0009241 (UMLS CUI [1])
C3203509 (UMLS CUI [2])
Operative Surgical Procedures Parkinson Disease
Item
history of surgical intervention for pd.
boolean
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Motor Complication Levodopa Induced | Complication Levodopa Induced
Item
history of l-dopa-induced motor or non-motor complication.
boolean
C0682711 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
C0205263 (UMLS CUI [1,4])
C0009566 (UMLS CUI [2,1])
C0023570 (UMLS CUI [2,2])
C0205263 (UMLS CUI [2,3])
Malignant Neoplasms
Item
history of malignancy.
boolean
C0006826 (UMLS CUI [1])
Allergic Reaction Severe Pharmaceutical Preparations | Anaphylaxis Severe Pharmaceutical Preparations
Item
history of severe allergic or anaphylactic reactions to any drug.
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Renal dysfunction
Item
clinically significant renal dysfunction.
boolean
C3279454 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c >7.0%.
boolean
C0474680 (UMLS CUI [1])
Electrocardiography Clinical Significance
Item
clinically significant baseline ecg.
boolean
C1623258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hypotension, Orthostatic
Item
orthostatic hypotension.
boolean
C0020651 (UMLS CUI [1])
Carbidopa / Levodopa | Benserazide / Levodopa
Item
treatment with l-dopa/carbidopa or l-dopa/benserazide for more than 6 cumulative months at anytime since subject's initial pd diagnosis.
boolean
C0353697 (UMLS CUI [1])
C0358787 (UMLS CUI [2])
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