Diagnosis of idiopathic Parkinson's disease and demonstrating lack of control with L-dopa therapy
Item
Diagnosis of idiopathic Parkinson's disease (according to modified Hoehn & Yard criteria Stages I - IV) and demonstrating lack of control with L-dopa therapy (e.g. end of dose akinesia, simple on/off fluctuations)
boolean
C0030567 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C3639878 (UMLS CUI [2])
C0023570 (UMLS CUI [3,1])
C0243148 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C0085623 (UMLS CUI [4])
C0231239 (UMLS CUI [5,1])
C0852903 (UMLS CUI [5,2])
Receiving a stable dose of L-dopa for at least 4 weeks prior to screening
Item
Receiving a stable dose of L-dopa for at least 4 weeks prior to screening
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0220908 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Gender; Childbearing Potential | Contraceptive methods; Acceptance status | During; Clinical Trials | Randomization; Before | Study Completed
Item
If female of child-bearing potential, practicing a clinically accepted method of contraception during the study and for at least one month prior to randomization and one month following completion of study.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C3176353 (UMLS CUI [2,2])
C0347984 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
C0034656 (UMLS CUI [4,1])
C0332152 (UMLS CUI [4,2])
C2348557 (UMLS CUI [5])
30 years of age or greater at screening
Item
30 years of age or greater at screening
boolean
C0001779 (UMLS CUI [1])
A minimum of 3 hours awake "off-time" for each diary day recorded during the baseline period
Item
A minimum of 3 hours awake "off-time" for each diary day recorded during the baseline period
boolean
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
C3890583 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
C1442488 (UMLS CUI [3,1])
C0347984 (UMLS CUI [3,2])
Willing and able to comply with study procedures, including diary card completion and follow-up clinic visits
Item
Willing and able to comply with study procedures, including diary card completion and follow-up clinic visits
boolean
C0525058 (UMLS CUI [1])
C3890583 (UMLS CUI [2,1])
C0805732 (UMLS CUI [2,2])
C1522577 (UMLS CUI [3,1])
C0008952 (UMLS CUI [3,2])
Provided written informed consent for this study
Item
Provided written informed consent for this study
boolean
C0021430 (UMLS CUI [1])
Is subject either affiliated to or a beneficiary of a social security category?
Item
Is subject either affiliated to or a beneficiary of a social security category?
boolean
C0037435 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
C1550502 (UMLS CUI [1,3])
Late stage advanced subject demonstrating incapacitating peak dose or diphasic dyskinesia on their stable dose of L-dopa
Item
Late stage advanced subject demonstrating incapacitating peak dose or diphasic dyskinesia on their stable dose of L-dopa
boolean
C0544467 (UMLS CUI [1])
C3174092 (UMLS CUI [2,1])
C0444505 (UMLS CUI [2,2])
C0013384 (UMLS CUI [3])
C0023570 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Consumption of any dopamine agonist, including ropinirole, within four weeks of randomization in the study
Item
Consumption of any dopamine agonist, including ropinirole, within four weeks of randomization in the study
boolean
C0178601 (UMLS CUI [1])
C0244821 (UMLS CUI [2])
C0034656 (UMLS CUI [3])
Severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the Investigator, would render the subject unsuitable for the study
Item
Severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the Investigator, would render the subject unsuitable for the study (e.g. psychiatric, haematological, renal, hepatic, endocrinology, neurological other than Parkinson's disease, cardiovascular, or active malignancy other than basal cell carcinoma)
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0030567 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0279810 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0007222 (UMLS CUI [10])
C0006826 (UMLS CUI [11])
C0007117 (UMLS CUI [12,1])
C0205394 (UMLS CUI [12,2])
Crippling degenerative arthritis or other physical or mental condition(s) which would preclude accurate assessment of efficacy or safety
Item
Crippling degenerative arthritis or other physical or mental condition(s) which would preclude accurate assessment of efficacy or safety
boolean
C0003864 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0010331 (UMLS CUI [1,3])
C3714565 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C3840291 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C1280519 (UMLS CUI [4,1])
C0220825 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0549076 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
Prior or current major psychosis (e.g. schizophrenia or psychotic depression) scoring e.g. 3 or 4 on UPDRS item II (thought disorder) or item III (depression)
Item
Prior or current major psychosis (e.g. schizophrenia or psychotic depression) scoring e.g. 3 or 4 on UPDRS item II (thought disorder) or item III (depression)
boolean
C0033975 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
C0743072 (UMLS CUI [3])
C3639837 (UMLS CUI [4])
C3639721 (UMLS CUI [5,1])
C0011581 (UMLS CUI [5,2])
Severe clinical dementia scoring e.g. 3 or 4 on UPDRS item I (mentation)
Item
Severe clinical dementia scoring e.g. 3 or 4 on UPDRS item I (mentation)
boolean
C3639721 (UMLS CUI [1,1])
C3494652 (UMLS CUI [1,2])
Severe dizziness or fainting due to postural hypotension on standing
Item
Severe dizziness or fainting due to postural hypotension on standing
boolean
C0012833 (UMLS CUI [1,1])
C0020651 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0039070 (UMLS CUI [2,1])
C0020651 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Personal history of melanoma
Item
Personal history of melanoma
boolean
C0025202 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Clinically significant abnormalities in laboratory or ECG tests at screening.
Item
Clinically significant abnormalities in laboratory or ECG tests at screening. If findings are outside the normal range and the subject is included, it must be documented by the investigator that the findings are not of clinical significance
boolean
C1853129 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0522055 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
C0086715 (UMLS CUI [3])
C2826293 (UMLS CUI [4])
Diagnosed with an impulse control disorder.
Item
Diagnosed with an impulse control disorder. The modified MIDI will be conducted at screening. Subjects who score positive for this screen must be referred to a specialist for a diagnostic evaluation
boolean
C0021122 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
C0430022 (UMLS CUI [3,1])
C0220825 (UMLS CUI [3,2])
Planning suicide | Feeling suicidal (finding) | Suicide attempt
Item
Active suicidal plan/intent or have had active suicidal thoughts in the past 6 months. Subjects who have a history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt
boolean
C0424001 (UMLS CUI [1])
C0424000 (UMLS CUI [2])
C0038663 (UMLS CUI [3])
Current alcohol or drug dependence
Item
Current alcohol or drug dependence
boolean
C0038580 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
Adverse reactions; Clinical Significance; ropinirole | Hypersensitivity; Clinical Significance; ropinirole | Chemical Structure; Similarity | Long-term drug therapy; ropinirole
Item
Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude long-term dosing with ropinirole
boolean
C0559546 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0244821 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0244821 (UMLS CUI [2,3])
C0220807 (UMLS CUI [3,1])
C2348205 (UMLS CUI [3,2])
C0420257 (UMLS CUI [4,1])
C0244821 (UMLS CUI [4,2])
Withdraw (activity); Medication dose | Introduction procedure; Medication dose | Dose Modification; Hormone replacement therapy | Drug inhibition of cytochrome p450 CYP1A2 enzyme | Ciprofloxacin | Fluvoxamine | Cimetidine | Ethinyl Estradiol | Tobacco | Omeprazole | Randomization; Before | Therapeutic procedure; chronic | Medication regimen; Stable status
Item
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYPIA2 (e.g. Ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYPIA2 (e.g. tobacco, omeprazole) within 7 days prior to enrollment (randomization). Any subject already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrollment (randomization) through the end of the treatment period
boolean
C2349954 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C1293116 (UMLS CUI [2,1])
C3174092 (UMLS CUI [2,2])
C1707811 (UMLS CUI [3,1])
C0282402 (UMLS CUI [3,2])
C1827504 (UMLS CUI [4])
C0008809 (UMLS CUI [5])
C0085228 (UMLS CUI [6])
C0008783 (UMLS CUI [7])
C0015011 (UMLS CUI [8])
C3898767 (UMLS CUI [9,1])
C1620185 (UMLS CUI [9,2])
C0040329 (UMLS CUI [10])
C0028978 (UMLS CUI [11])
C0034656 (UMLS CUI [12,1])
C0332152 (UMLS CUI [12,2])
C0087111 (UMLS CUI [13,1])
C0205191 (UMLS CUI [13,2])
C0237125 (UMLS CUI [14])
Female currently pregnant or breast-feeding
Item
Female currently pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Use of an Investigational drug from 30 days or 5 half-lives (which ever is longer) prior to baseline (randomization) through to the end of the treatment period
Item
Use of an Investigational drug from 30 days or 5 half-lives (which ever is longer) prior to baseline (randomization) through to the end of the treatment period
boolean
C0013230 (UMLS CUI [1])
C1442488 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0034656 (UMLS CUI [3])
C1531784 (UMLS CUI [4])