Parkinson Disease
Item
idiopathic parkinson's disease.
boolean
C0030567 (UMLS CUI [1])
Levodopa-induced dyskinesias Dose Peak | DOPA Decarboxylase Inhibitors Associated with Dyskinesia Dose Peak | Disability - moderate Unified Parkinson's Disease Rating Scale Questionnaire
Item
levodopa/ddi associated peak-dose dyskinesia which is at least moderately disabling and present for ≥25% of the waking day (updrs part iv, items 32 and 33, each ≥ 2).
boolean
C1970038 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0444505 (UMLS CUI [1,3])
C0598272 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0013384 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])
C0444505 (UMLS CUI [2,5])
C0424989 (UMLS CUI [3,1])
C3639721 (UMLS CUI [3,2])
Antiparkinson Agents Stable
Item
stable parkinson's medication for at least 1 month prior to randomization.
boolean
C0003405 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Hoehn and Yahr grades
Item
hoehn and yahr stages 1 to 4 during 'off' period.
boolean
C0451215 (UMLS CUI [1])
Informed Consent
Item
demonstrated ability to comprehend and give informed consent.
boolean
C0021430 (UMLS CUI [1])
Subject Diary Complete Willing
Item
ability to complete patient diary.
boolean
C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Condition Clinical Significance | Exception Condition Associated with Parkinson Disease
Item
other clinically significant conditions apart from those typically associated with parkinson's disease.
boolean
C0348080 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0030567 (UMLS CUI [2,4])
Pharmaceutical Preparations Associated with Exacerbation Dyskinesia | Drug-induced extrapyramidal side effects | Pharmaceutical Preparations Associated with Tardive Dyskinesia | Pharmaceutical Preparations Associated with Induction Liver enzyme | Antipsychotic Agents | Pharmaceutical Preparations Metabolized CYP1A2 | Pharmaceutical Preparations Metabolized CYP2B6 | Pharmaceutical Preparations Metabolized CYP2C19 | Pharmaceutical Preparations Metabolized CYP2C9 | Pharmaceutical Preparations Metabolized CYP2D6 | Pharmaceutical Preparations Metabolized CYP2E1
Item
intake of medication associated with exacerbation of dyskinesia or with extrapyramidal side effects and tardive dyskinesia or induction of liver enzymes; neuroleptics; or specified drugs known to be substantially metabolized through the following cytochrome p450 isoenzymes: 1a2, 2b6, 2c19, 2c9, 2d6, and 2e1.
boolean
C0013227 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
C0013384 (UMLS CUI [1,4])
C0858266 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0686347 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0205263 (UMLS CUI [4,3])
C0443764 (UMLS CUI [4,4])
C0040615 (UMLS CUI [5])
C0013227 (UMLS CUI [6,1])
C1524026 (UMLS CUI [6,2])
C0207509 (UMLS CUI [6,3])
C0013227 (UMLS CUI [7,1])
C1524026 (UMLS CUI [7,2])
C1828468 (UMLS CUI [7,3])
C0013227 (UMLS CUI [8,1])
C1524026 (UMLS CUI [8,2])
C0960580 (UMLS CUI [8,3])
C0013227 (UMLS CUI [9,1])
C1524026 (UMLS CUI [9,2])
C0608437 (UMLS CUI [9,3])
C0013227 (UMLS CUI [10,1])
C1524026 (UMLS CUI [10,2])
C0057223 (UMLS CUI [10,3])
C0013227 (UMLS CUI [11,1])
C1524026 (UMLS CUI [11,2])
C0010763 (UMLS CUI [11,3])
St. john's wort | Ginkgo biloba
Item
use of st. john's wort or ginkgo biloba within 48 hrs prior to randomization and until the last treatment day with the study medication.
boolean
C0936242 (UMLS CUI [1])
C0772125 (UMLS CUI [2])
Investigational New Drugs
Item
intake of an investigational drug within 30 days prior to initial screening.
boolean
C0013230 (UMLS CUI [1])