ID

31399

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00442780

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 NCT00442780

Engelsk

Eligibility Parkinson's Disease NCT00442780

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Informed Consent | Patient authorization

Datatyp

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.
Beskrivning

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

Datatyp

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).
Beskrivning

Modified Hoehn and Yahr Staging

Datatyp

boolean

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

UPDRS Motor Score

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
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-pd 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 as defined by the diagnostic and statistical manual of mental disorders.
Beskrivning

Axis I diagnosis

Datatyp

boolean

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

Cognition Disorders | Neuropsychiatric syndrome

Datatyp

boolean

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

Operative Surgical Procedures Parkinson Disease

Datatyp

boolean

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

Motor Complication Levodopa Induced | Complication Levodopa Induced

Datatyp

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.
Beskrivning

Malignant Neoplasms

Datatyp

boolean

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

Allergic Reaction Severe Pharmaceutical Preparations | Anaphylaxis Severe Pharmaceutical Preparations

Datatyp

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.
Beskrivning

Renal dysfunction

Datatyp

boolean

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

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
clinically significant baseline 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
treatment with l-dopa/carbidopa or l-dopa/benserazide for more than 6 cumulative months at anytime since subject's initial pd diagnosis.
Beskrivning

Carbidopa / Levodopa | Benserazide / Levodopa

Datatyp

boolean

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

Eligibility Parkinson's Disease NCT00442780

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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