Informações:
Falhas:
ID
13304
Descrição
Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations; ODM derived from: https://clinicaltrials.gov/show/NCT00203034
Link
https://clinicaltrials.gov/show/NCT00203034
Palavras-chave
Versões (1)
- 01/02/2016 01/02/2016 -
Transferido a
1 de fevereiro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00203034
Eligibility Parkinson's Disease NCT00203034
- StudyEvent: Eligibility
Similar models
Eligibility Parkinson's Disease NCT00203034
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
idiopathic parkinson
Item
men and women with idiopathic parkinson's disease whose diagnosis is confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without any other known or suspected cause of parkinsonism.
boolean
C0030567 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C0332240 (UMLS CUI [1,2])
levodopa related motor fluctuations
Item
subjects must experience levodopa related motor fluctuations averaging at least 2.5 hours daily in the off state.
boolean
C1868976 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,2])
antiparkinson agents
Item
subjects must be taking optimized levodopa/carbidopa or levodopa /benserazide carbidopa/levodopa therapy (based on investigator's judgment), stable for at least 14 days prior to baseline. subjects must be receiving at least 3 daily doses of levodopa, not including a bedtime dose.
boolean
C0003405 (UMLS CUI [1])
selegiline
Item
selegiline must be discontinued for at least 90 days prior to baseline.
boolean
C0036579 (UMLS CUI [1])
age
Item
subject must be age 30 or older.
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
subjects must be willing and able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
comorbidity
Item
subjects with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. such conditions may include cardiovascular, pulmonary, hepatic, renal, or metabolic diseases or malignancies as determined by medical history, physical exam, laboratory tests, chest x-ray, or ecg for parkinson's disease [e.g., pallidotomy, thalamotomy, and deep brain stimulation (dbs)] within the 12 months preceding the baseline visit.
boolean
C0009488 (UMLS CUI [1])
neurosurgery
Item
subjects who have undergone neurosurgical transplantation are excluded regardless of when the procedure(s) was performed. no programming changes are permitted in subjects who have undergone dbs.
boolean
C0524850 (UMLS CUI [1])
study subject participation status
Item
participation in a previous clinical trial of rasagiline. concomitant therapy with mao inhibitors, reserpine, methyldopa within the past three months, or treatment with an anti-emetic or neuroleptic medication with central dopamine antagonist activity with the past six months.
boolean
C2348568 (UMLS CUI [1])