adults without childbearing potential
Item
Men or women (who are not of childbearing potential, defined as those who have been naturally free of menses for at least 2 years or have undergone hysterectomy or surgical sterilization), age 30 years or older.
boolean
C0001675 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
diagnosis of Parkinson's disease according to Hoehn&Yahr Stage I-III
Item
Diagnosis of idiopathic Parkinson's disease according to Hoehn & Yahr Stage I-III based on medical history and neurological examination.
boolean
C0030567 (UMLS CUI [1,1])
C0451215 (UMLS CUI [1,2])
candidate and authorization for dopaminergic therapy
Item
Candidate for dopaminergic therapy and warrants/requires dopaminergic therapy.
boolean
C0013036 (UMLS CUI [1,1])
C0680281 (UMLS CUI [1,2])
informed consent
Item
Written informed consent prior to admission to the study.
boolean
C0021430 (UMLS CUI [1])
date informed consent signed:
Item
Date informed consent signed
date
C0011008 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
investigator's signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
exception approved by medical monitor
Item
If any question is answered YES, was exception approved by Medical Monitor?
boolean
C1708968 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
name of medical monitor
Item
name of medical monitor
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
date of approval
Item
Date of approval
date
C2346844 (UMLS CUI [1])
psychiatric, hematological, renal, hepatic, endocrinological, neurological or cardiovascular diseases or active malignancy
Item
Presence - or history within the previous 3 months - of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological, (otherthan Parkinson's disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrythmias, CVA), or active malignancy (other than basal cell cancer).
boolean
C0004936 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C0007222 (UMLS CUI [7])
C0006826 (UMLS CUI [8])
AST or ALT or serum creatinine increased or other clinically significant laboratory or ECG abnormalities
Item
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine > 2 x the upper limit of normal (ULN) or other clinically significant laboratory or ECG abnormalities at screening.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
C0438215 (UMLS CUI [4])
C1832603 (UMLS CUI [5])
severe dizziness, syncope or orthostatic hypotension
Item
Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure (supine, erect) from baseline values of 30 mmHg for systolic pressure; 20 mmHg for diastolic pressure.
boolean
C0012833 (UMLS CUI [1])
C0039070 (UMLS CUI [2])
C0020651 (UMLS CUI [3])
sleep disorder on Epworth sleep scale
Item
Significant sleep disorder or screening Epworth Sleep Score~ 9.
boolean
C0851578 (UMLS CUI [1,1])
C3541276 (UMLS CUI [1,2])
L-dopa treatment
Item
History of previous treatment with any L-dopa dose or preparation for more than weeks. (L-dopa treatment must be discontinued for at least a 2-week wash-out period before enrollment.)
boolean
C0023570 (UMLS CUI [1])
dopaminergic therapy
Item
History of other dopaminergic therapy within two weeks before enrollment. (Note: Patients on dopaminergic therapy may be enrolled if the agent is stopped for a 2-week wash-out period prior to enrollment. Patients on selegiline may be enrolled, but must remain on their current dose during study participation.)
boolean
C0013036 (UMLS CUI [1])
hormone replacement therapy, CYP1A2 inducers or CYP1A2 inhibitors
Item
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially induce CYP1A2 (e.g., ciprofloxacin, fluvoxacine, cimetidine, ethinyloestradiol) or inhibit CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to enrollment. Patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrollment through Day 14.
boolean
C0282402 (UMLS CUI [1])
C3850050 (UMLS CUI [2])
C3850068 (UMLS CUI [3])
hypersensitivity or adverse reactions to ropinirole
Item
Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure. In particular, patients with inadequate tolerance of ropinirole at doses below 12 mg per day are to be excluded.
boolean
C0020517 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0244821 (UMLS CUI [2,2])
investigational drugs
Item
Use of any investigational drug within the 30 days or 5 half-lives (whichever is longer) before the start of study dosing.
boolean
C0013230 (UMLS CUI [1])
drug abuse or abuse of alcohol
Item
Recent history, or suspicion, of drug dependence or abuse of alcohol (with alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units; one unit is equivalent to half a pint of beer, one measure of spirits, or one glass of wine).
boolean
C0013146 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
concern about the patient's compliance behavior and the use of new or prohibited concomitant medications
Item
Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.
boolean
C1321605 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
blood donation
Item
Blood donation within the previous two months.
boolean
C0005794 (UMLS CUI [1])
pregnancy or lactation
Item
Pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
investigator's signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
exception approved by medical monitor
Item
If any question is answered YES, was exception approved by Medical Monitor?
boolean
C1708968 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
name of medical monitor
Item
name of medical monitor
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
date of approval
Item
Date of approval
date
C2346844 (UMLS CUI [1])