Protocol identifier
Item
Protocol identifier
float
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Description
Item
Visit Description
text
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Monitor data validation check
Item
Monitor data validation check
integer
C1519941 (UMLS CUI [1,1])
C0030695 (UMLS CUI [1,2])
Eligibility question
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item
1. Men or non-pregnant/non-breast-feeding women of at least 30 years of age but no older than 70 at screening. Women of child-bearing potential must be practicing a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device [IUD], or diaphram IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception [i.e. Norplantt System]), during the study and for at least one month prior to randomization and one month following completion of the study.
text
C0032961 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
Code List
1. Men or non-pregnant/non-breast-feeding women of at least 30 years of age but no older than 70 at screening. Women of child-bearing potential must be practicing a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device [IUD], or diaphram IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception [i.e. Norplantt System]), during the study and for at least one month prior to randomization and one month following completion of the study.
CL Item
failed (failed)
C1512693 (UMLS CUI-1)
C1550543 (UMLS CUI-2)
(Comment:en)
CL Item
fulfilled (fulfilled)
C1512693 (UMLS CUI-1)
C1550543 (UMLS CUI-2)
(Comment:en)
Item
2. Diagnosis of idiopathic Parkinson's Disease (according to modified Hoehn & Yahr criteria Stages 1-111) and demonstrating lack of control with L-dopa therapy (e.g. mild wearing off, simple on/off fluctuations).
text
C0865475 (UMLS CUI [1])
Code List
2. Diagnosis of idiopathic Parkinson's Disease (according to modified Hoehn & Yahr criteria Stages 1-111) and demonstrating lack of control with L-dopa therapy (e.g. mild wearing off, simple on/off fluctuations).
CL Item
failed (failed)
C0231175 (UMLS CUI-1)
(Comment:en)
CL Item
fulfilled (fulfilled)
C1550543 (UMLS CUI-1)
(Comment:en)
Item
3. Subjects on 600 mg or less of L-dopa therapy for two years or less. Patients on combination therapy such as COMTAN/L-dopa or L-dopa and amantadine are also eligible.
text
C3806728 (UMLS CUI [1])
Code List
3. Subjects on 600 mg or less of L-dopa therapy for two years or less. Patients on combination therapy such as COMTAN/L-dopa or L-dopa and amantadine are also eligible.
CL Item
fulfilled (fulfilled)
Item
4. Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
text
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Code List
4. Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
CL Item
fulfilled (fulfilled)
Item
5. Provide written informed consent for this study.
text
C0021430 (UMLS CUI [1])
Code List
5. Provide written informed consent for this study.
CL Item
fulfilled (fulfilled)
Item
6. Be willing and able to comply with study procedures, including follow-up clinic visits.
text
Code List
6. Be willing and able to comply with study procedures, including follow-up clinic visits.
CL Item
fulfilled (fulfilled)
Dyskinesia
Item
1. Any stage of Parkinson's disease in which the subject demonstrates or has a history consistent with dyskinesia.
boolean
C0013384 (UMLS CUI [1])
Disease
Item
2. Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than Parkinson's Disease), or cardiovascular disease or active malignancy (other than basal cell cancer).
boolean
C0012634 (UMLS CUI [1])
Abnormality
Item
3. Any abnormality, at Screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG.
boolean
C1704258 (UMLS CUI [1])
dizziness or fainting
Item
4. Recent history of severe dizziness or fainting due to postural hypotension on standing.
boolean
C0012833 (UMLS CUI [1])
C0039070 (UMLS CUI [2])
Dementia
Item
5. Clinically relevant Dementia or a MMSE score of <26.
boolean
C0497327 (UMLS CUI [1])
alcohol or drug abuse
Item
6. Recent history or current evidence of alcohol or drug abuse at the time of enrollment.
boolean
C0038586 (UMLS CUI [1])
Use of MAO inhibitors
Item
7. Use of monoamine oxidase (MAO) inhibitors within three weeks of the screening visit except for the selective MAO-B inhibitor, selegiline.
boolean
C0026457 (UMLS CUI [1])
adverse reactions to ropinirole
Item
8. 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 longterm dosing with ropinirole CR.
boolean
C0244821 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
hormone replacement therapy
Item
9. Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol} or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrollment. Subjects already on chronic therapy with any of these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrollment through the end of the Treatment Period.
boolean
C0282402 (UMLS CUI [1])
Use of an investigational drug
Item
10. Use of an investigational drug within 30 days or 5 half-lives (which ever is longer).
boolean
C0013230 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])