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.
integer
C0001675 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
Code List
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.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Diagnosis of idiopathic Parkinson's disease according to Hoehn & Yahr Stage I-III based on medical history and neurological examination.
integer
C0030567 (UMLS CUI [1,1])
C0451215 (UMLS CUI [1,2])
Code List
Diagnosis of idiopathic Parkinson's disease according to Hoehn & Yahr Stage I-III based on medical history and neurological examination.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Candidate for dopaminergic therapy and warrants/requires dopaminergic therapy.
integer
C0013036 (UMLS CUI [1,1])
C0680281 (UMLS CUI [1,2])
Code List
Candidate for dopaminergic therapy and warrants/requires dopaminergic therapy.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Written informed consent prior to admission to the study.
integer
C0021430 (UMLS CUI [1])
Code List
Written informed consent prior to admission to the study.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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])
Item
If any question is answered YES, was exception approved by Medical Monitor?
integer
C1708968 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
Code List
If any question is answered YES, was exception approved by Medical Monitor?
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
name of medical monitor
Item
Exception approved by
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
date of approval
Item
Date of approval
date
C2346844 (UMLS CUI [1])
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).
integer
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])
Code List
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).
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.
integer
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
C0438215 (UMLS CUI [4])
C0522055 (UMLS CUI [5])
Code List
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.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.
integer
C0012833 (UMLS CUI [1])
C0039070 (UMLS CUI [2])
C0020651 (UMLS CUI [3])
Code List
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.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Significant sleep disorder or screening Epworth Sleep Score~ 9.
integer
C0851578 (UMLS CUI [1,1])
C3541276 (UMLS CUI [1,2])
Code List
Significant sleep disorder or screening Epworth Sleep Score~ 9.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.)
integer
C0023570 (UMLS CUI [1])
Code List
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.)
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.)
integer
C0013036 (UMLS CUI [1])
Code List
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.)
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.
integer
C0282402 (UMLS CUI [1])
C3850050 (UMLS CUI [2])
C3850068 (UMLS CUI [3])
Code List
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.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.
integer
C0020517 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0244821 (UMLS CUI [2,2])
Code List
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.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Use of any investigational drug within the 30 days or 5 half-lives (whichever is longer) before the start of study dosing.
integer
C0013230 (UMLS CUI [1])
Code List
Use of any investigational drug within the 30 days or 5 half-lives (whichever is longer) before the start of study dosing.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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).
integer
C0013146 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
Code List
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).
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
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.
integer
C1321605 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Code List
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.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Blood donation within the previous two months.
integer
C0005794 (UMLS CUI [1])
Code List
Blood donation within the previous two months.
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
Item
Pregnancy or lactation
text
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Code List
Pregnancy or lactation
CL Item
Not done (Not done)
investigator's signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Item
If any question is answered YES, was exception approved by Medical Monitor?
integer
C1708968 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
Code List
If any question is answered YES, was exception approved by Medical Monitor?
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
name of medical monitor
Item
Exception approved by
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
date of approval
Item
Date of approval
date
C2346844 (UMLS CUI [1])