Informações:
Falhas:
ID
17380
Descrição
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
Palavras-chave
Versões (1)
- 10/09/2016 10/09/2016 -
Transferido a
10 de setembro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Advanced Parkinson's Disease NCT01723904
Eligibility Advanced Parkinson's Disease NCT01723904
- StudyEvent: Eligibility
Similar models
Eligibility Advanced Parkinson's Disease NCT01723904
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])