ID

31425

Description

Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off; ODM derived from: https://clinicaltrials.gov/show/NCT00642356

Link

https://clinicaltrials.gov/show/NCT00642356

Keywords

Versions (1)
  1. 8/21/18 8/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00642356

English

Eligibility Parkinson's Disease NCT00642356

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
be aged 30 to 85 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
be male or female - female patients must be either not of childbearing potential (defined as post menopausal for at least one year or surgically incapable of bearing children), or must be practicing contraceptive methods as outlined in the protocol.
Description

Gender | Childbearing Potential Absent | Postmenopausal state | Female Sterilization | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0015787
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
have a clinical diagnosis of idiopathic parkinson's disease, exhibiting at least 2 of 3 symptoms (rigidity, resting tremor, bradykinesia)
Description

Parkinson Disease | Symptoms Quantity | Muscle Rigidity | Resting Tremor | Bradykinesia

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0026837
UMLS CUI [4]
C0234379
UMLS CUI [5]
C0233565
have non-motor symptoms of end of dose wearing off i.e., the presence of at least one non-motor symptom of parkinson's disease which improves with the next immediate release (ir) carbidopa/levodopa dose as determined by the quantitative wearing-off questionnaire 9 and investigator's assessment. at least one non-motor item has to show a severity of at least 2 points (of a maximum of 4) and show an improvement of at least 1 one hour after immediate release (ir) carbidopa/levodopa administration. also there should not have been a deterioration of 1 point or more in another non-motor item.(all criteria must be fulfilled)
Description

Symptoms End Dose Wearing off | Exception Motor symptoms | Symptoms Quantity Parkinson Disease | Improvement Carbidopa / Levodopa Immediate Release Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2746065
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C1504539
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0426980
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0030567
UMLS CUI [4,1]
C2986411
UMLS CUI [4,2]
C0353697
UMLS CUI [4,3]
C1708470
be taking a stable dose of immediate release (ir) carbidopa/levodopa for at least 21 days prior to randomization at an equivalent total daily dose of immediate release (ir) carbidopa/levodopa between 300 to 800 mg. dosing should be either 3 to 6 times per day.
Description

Carbidopa / Levodopa Immediate Release Dose Stable | Carbidopa / Levodopa Immediate Release Total Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0353697
UMLS CUI [1,2]
C1708470
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0353697
UMLS CUI [2,2]
C1708470
UMLS CUI [2,3]
C2986497
UMLS CUI [2,4]
C0456683
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a previous history of being non-responsive to entacapone or tolcapone treatment or having experienced a serious or severe adverse event(s) which resulted in the discontinuation of treatment from the previous use of entacapone or tolcapone; current treatment with entacapone or tolcapone or discontinued treatment with either therapy or discontinued less than 60 days before randomization;
Description

Entacapone Unresponsive to Treatment | Tolcapone Unresponsive to Treatment | Serious Adverse Event | Adverse event Severe | Medication discontinued Entacapone | Medication discontinued Tolcapone | Entacapone | Tolcapone

Data type

boolean

Alias
UMLS CUI [1,1]
C0165921
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0246330
UMLS CUI [2,2]
C0205269
UMLS CUI [3]
C1519255
UMLS CUI [4,1]
C0877248
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0558681
UMLS CUI [5,2]
C0165921
UMLS CUI [6,1]
C0558681
UMLS CUI [6,2]
C0246330
UMLS CUI [7]
C0165921
UMLS CUI [8]
C0246330
have a history, signs, or symptoms suggesting a diagnosis of secondary or atypical parkinsonism;
Description

Secondary Parkinson Disease | Atypical Parkinsonism | Sign or Symptom Suggestive of Secondary Parkinson Disease | Sign or Symptom Suggestive of Atypical Parkinsonism

Data type

boolean

Alias
UMLS CUI [1]
C0030569
UMLS CUI [2]
C4302185
UMLS CUI [3,1]
C3540840
UMLS CUI [3,2]
C0332299
UMLS CUI [3,3]
C0030569
UMLS CUI [4,1]
C3540840
UMLS CUI [4,2]
C0332299
UMLS CUI [4,3]
C4302185
have unstable parkinson's disease requiring frequent booster doses;
Description

Parkinson Disease Unstable | Requirement Dose Additional Frequent

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1524062
UMLS CUI [2,4]
C0332183
disabling dyskinesias, indicated by a score of greater than 1 on unified parkinson disease rating scale question #32, or a score of greater than 1 on unified parkinson disease rating scale question #33;
Description

Dyskinesia Disabling Unified Parkinson's Disease Rating Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0013384
UMLS CUI [1,2]
C4061999
UMLS CUI [1,3]
C3639721
have a history or current diagnosis of psychotic features according to the investigator;
Description

Feature Psychotic

Data type

boolean

Alias
UMLS CUI [1,1]
C2348519
UMLS CUI [1,2]
C0033975
other protocol-defined inclusion/exclusion criteria applied to the study.
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Parkinson's Disease NCT00642356

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
be aged 30 to 85 years.
boolean
C0001779 (UMLS CUI [1])
Gender | Childbearing Potential Absent | Postmenopausal state | Female Sterilization | Childbearing Potential Contraceptive methods
Item
be male or female - female patients must be either not of childbearing potential (defined as post menopausal for at least one year or surgically incapable of bearing children), or must be practicing contraceptive methods as outlined in the protocol.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Parkinson Disease | Symptoms Quantity | Muscle Rigidity | Resting Tremor | Bradykinesia
Item
have a clinical diagnosis of idiopathic parkinson's disease, exhibiting at least 2 of 3 symptoms (rigidity, resting tremor, bradykinesia)
boolean
C0030567 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0026837 (UMLS CUI [3])
C0234379 (UMLS CUI [4])
C0233565 (UMLS CUI [5])
Symptoms End Dose Wearing off | Exception Motor symptoms | Symptoms Quantity Parkinson Disease | Improvement Carbidopa / Levodopa Immediate Release Dose
Item
have non-motor symptoms of end of dose wearing off i.e., the presence of at least one non-motor symptom of parkinson's disease which improves with the next immediate release (ir) carbidopa/levodopa dose as determined by the quantitative wearing-off questionnaire 9 and investigator's assessment. at least one non-motor item has to show a severity of at least 2 points (of a maximum of 4) and show an improvement of at least 1 one hour after immediate release (ir) carbidopa/levodopa administration. also there should not have been a deterioration of 1 point or more in another non-motor item.(all criteria must be fulfilled)
boolean
C1457887 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1504539 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0426980 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0030567 (UMLS CUI [3,3])
C2986411 (UMLS CUI [4,1])
C0353697 (UMLS CUI [4,2])
C1708470 (UMLS CUI [4,3])
Carbidopa / Levodopa Immediate Release Dose Stable | Carbidopa / Levodopa Immediate Release Total Dose U/day
Item
be taking a stable dose of immediate release (ir) carbidopa/levodopa for at least 21 days prior to randomization at an equivalent total daily dose of immediate release (ir) carbidopa/levodopa between 300 to 800 mg. dosing should be either 3 to 6 times per day.
boolean
C0353697 (UMLS CUI [1,1])
C1708470 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0353697 (UMLS CUI [2,1])
C1708470 (UMLS CUI [2,2])
C2986497 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Entacapone Unresponsive to Treatment | Tolcapone Unresponsive to Treatment | Serious Adverse Event | Adverse event Severe | Medication discontinued Entacapone | Medication discontinued Tolcapone | Entacapone | Tolcapone
Item
have a previous history of being non-responsive to entacapone or tolcapone treatment or having experienced a serious or severe adverse event(s) which resulted in the discontinuation of treatment from the previous use of entacapone or tolcapone; current treatment with entacapone or tolcapone or discontinued treatment with either therapy or discontinued less than 60 days before randomization;
boolean
C0165921 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0246330 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C1519255 (UMLS CUI [3])
C0877248 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0558681 (UMLS CUI [5,1])
C0165921 (UMLS CUI [5,2])
C0558681 (UMLS CUI [6,1])
C0246330 (UMLS CUI [6,2])
C0165921 (UMLS CUI [7])
C0246330 (UMLS CUI [8])
Secondary Parkinson Disease | Atypical Parkinsonism | Sign or Symptom Suggestive of Secondary Parkinson Disease | Sign or Symptom Suggestive of Atypical Parkinsonism
Item
have a history, signs, or symptoms suggesting a diagnosis of secondary or atypical parkinsonism;
boolean
C0030569 (UMLS CUI [1])
C4302185 (UMLS CUI [2])
C3540840 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0030569 (UMLS CUI [3,3])
C3540840 (UMLS CUI [4,1])
C0332299 (UMLS CUI [4,2])
C4302185 (UMLS CUI [4,3])
Parkinson Disease Unstable | Requirement Dose Additional Frequent
Item
have unstable parkinson's disease requiring frequent booster doses;
boolean
C0030567 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1524062 (UMLS CUI [2,3])
C0332183 (UMLS CUI [2,4])
Dyskinesia Disabling Unified Parkinson's Disease Rating Scale
Item
disabling dyskinesias, indicated by a score of greater than 1 on unified parkinson disease rating scale question #32, or a score of greater than 1 on unified parkinson disease rating scale question #33;
boolean
C0013384 (UMLS CUI [1,1])
C4061999 (UMLS CUI [1,2])
C3639721 (UMLS CUI [1,3])
Feature Psychotic
Item
have a history or current diagnosis of psychotic features according to the investigator;
boolean
C2348519 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria applied to the study.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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