ID

17380

Description

A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01723904

Link

https://clinicaltrials.gov/show/NCT01723904

Keywords

  1. 9/10/16 9/10/16 -
Uploaded on

September 10, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Advanced Parkinson's Disease NCT01723904

Eligibility Advanced Parkinson's Disease NCT01723904

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is male or female, aged ≥ 30 and < 80 years at informed consent
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject has idiopathic parkinson's disease, of more than 3 years duration, as defined by the cardinal sign, bradykinesia, and the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes, and without any known or suspected cause of parkinsonism
Description

parkinson

Data type

boolean

Alias
UMLS CUI [1]
C0030567
subject has motor fluctuations such as wearing, dyskinesia
Description

motor fluctuation

Data type

boolean

Alias
UMLS CUI [1]
C1868976
subject has experienced nocturias for at least 3 nights within 7 days prior to baseline
Description

nocturias

Data type

boolean

Alias
UMLS CUI [1]
C0028734
subject is taking levodopa (l-dopa, immediate and/or controlled release) in combination with benserazide or carbidopa and has been on a stable dose of l-dopa for at least 28 days prior to baseline (visit 2)
Description

levodopa

Data type

boolean

Alias
UMLS CUI [1]
C0358787
subject is taking a non-ergot dopamine agonist (pramipexole ≤ 1.5 mg/day or ropinirole ≤ 6.0 mg/day) and has been on a stable dose of non-ergot dopamine agonist for at least 28 days prior to baseline (visit 2)
Description

non-ergot dopamine agonist

Data type

boolean

Alias
UMLS CUI [1]
C2917438
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is receiving therapy with tolcapone or budipine
Description

tolcapone

Data type

boolean

Alias
UMLS CUI [1]
C0246330
subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to baseline (visit 2): alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase a (mao-a) inhibitors, methylphenidate, or amphetamine
Description

alpha-methyl dopa

Data type

boolean

Alias
UMLS CUI [1]
C0025741
subject has a history of symptomatic (not asymptomatic) orthostatic hypotension within the 6 months prior to baseline (visit 2)
Description

orthostatic hypotension

Data type

boolean

Alias
UMLS CUI [1]
C0020651
subject has a known hypersensitivity to any components of the study medication, such as a history of significant skin hypersensitivity to adhesives, known hypersensitivity to other transdermal medications, or has unresolved contact dermatitis
Description

dermatitis

Data type

boolean

Alias
UMLS CUI [1]
C0011603
subject is pregnant or nursing, or is of child-bearing potential (ie, is (i) not surgically sterile, or, (ii) not using adequate birth control methods [including at least one barrier method] or, (iii) not sexually abstinent, or (iv) not at least 2 years post menopausal)
Description

child-bearing potential

Data type

boolean

Alias
UMLS CUI [1]
C1960468
subject had a previous diagnosis of narcolepsy, sleep apnea syndrome, restless legs syndrome, or periodic limb movement disorder
Description

narcolepsy

Data type

boolean

Alias
UMLS CUI [1]
C0027404

Similar models

Eligibility Advanced Parkinson's Disease NCT01723904

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject is male or female, aged ≥ 30 and < 80 years at informed consent
boolean
C0001779 (UMLS CUI [1])
parkinson
Item
subject has idiopathic parkinson's disease, of more than 3 years duration, as defined by the cardinal sign, bradykinesia, and the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes, and without any known or suspected cause of parkinsonism
boolean
C0030567 (UMLS CUI [1])
motor fluctuation
Item
subject has motor fluctuations such as wearing, dyskinesia
boolean
C1868976 (UMLS CUI [1])
nocturias
Item
subject has experienced nocturias for at least 3 nights within 7 days prior to baseline
boolean
C0028734 (UMLS CUI [1])
levodopa
Item
subject is taking levodopa (l-dopa, immediate and/or controlled release) in combination with benserazide or carbidopa and has been on a stable dose of l-dopa for at least 28 days prior to baseline (visit 2)
boolean
C0358787 (UMLS CUI [1])
non-ergot dopamine agonist
Item
subject is taking a non-ergot dopamine agonist (pramipexole ≤ 1.5 mg/day or ropinirole ≤ 6.0 mg/day) and has been on a stable dose of non-ergot dopamine agonist for at least 28 days prior to baseline (visit 2)
boolean
C2917438 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
tolcapone
Item
subject is receiving therapy with tolcapone or budipine
boolean
C0246330 (UMLS CUI [1])
alpha-methyl dopa
Item
subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to baseline (visit 2): alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase a (mao-a) inhibitors, methylphenidate, or amphetamine
boolean
C0025741 (UMLS CUI [1])
orthostatic hypotension
Item
subject has a history of symptomatic (not asymptomatic) orthostatic hypotension within the 6 months prior to baseline (visit 2)
boolean
C0020651 (UMLS CUI [1])
dermatitis
Item
subject has a known hypersensitivity to any components of the study medication, such as a history of significant skin hypersensitivity to adhesives, known hypersensitivity to other transdermal medications, or has unresolved contact dermatitis
boolean
C0011603 (UMLS CUI [1])
child-bearing potential
Item
subject is pregnant or nursing, or is of child-bearing potential (ie, is (i) not surgically sterile, or, (ii) not using adequate birth control methods [including at least one barrier method] or, (iii) not sexually abstinent, or (iv) not at least 2 years post menopausal)
boolean
C1960468 (UMLS CUI [1])
narcolepsy
Item
subject had a previous diagnosis of narcolepsy, sleep apnea syndrome, restless legs syndrome, or periodic limb movement disorder
boolean
C0027404 (UMLS CUI [1])

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