ID

44205

Beskrivning

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Nyckelord

Versioner (2)
  1. 2019-02-12 2019-02-12 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0
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Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

Engelsk

Baseline - Eligibility Question

1 Formulär  
Eligibility Question
Beskrivning

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beskrivning

If No, ✔ all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.

Datatyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Subjects diagnosed with RLS using the RLS Diagnostic Clinical Interview and the International RLS Study Group (IRLSSG) Diagnostic Criteria at the Screening Visit.
Beskrivning

1. Subjects diagnosed with RLS using the RLS Diagnostic Clinical Interview and the International RLS Study Group (IRLSSG) Diagnostic Criteria at the Screening Visit.

Datatyp

boolean

Alias
UMLS CUI [1]
C0035258
UMLS CUI [2,1]
C1537061
UMLS CUI [2,2]
C0035258
2. Subjects > 18 years and < 80 years of age.
Beskrivning

2. Subjects > 18 years and < 80 years of age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. Subjects have had RLS symptoms with a history of a minimum of 20 evening and nights of RLS episodes during the month prior to the Screening Visit (e.g., any combination of evenings and/or nights for >20 days). In the case of a subject currently receiving medication for the treatment of RLS at the Screening Visit, this inclusion criterion can be waived. However, the subject must discontinue and washout any previous medication for the treatment of RLS or sleep prior to the Baseline Visit (Day 0). The minimum discontinuation period for washout is generally 5 half-lives of the medication or 7 consecutive nights medication-free prior to baseline, whichever is the longer period.
Beskrivning

3. Restless Legs Syndrome; Frequencies (time pattern) | Restless Legs Syndrome; Pharmaceutical Preparations; Washout Period

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439603
UMLS CUI [2,1]
C0035258
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1710661
4.During the Washout and Screening Phase, RLS symptoms must be present for at least 4 of the last 7 evening and nights immediately prior to the Baseline Visit (e.g., any combination of evenings and/or nights for >4 days).
Beskrivning

4.During the Washout and Screening Phase, RLS symptoms must be present for at least 4 of the last 7 evening and nights immediately prior to the Baseline Visit (e.g., any combination of evenings and/or nights for >4 days).

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0439603
UMLS CUI [2,1]
C0220908
UMLS CUI [2,2]
C0035258
UMLS CUI [2,3]
C0439603
5.Subjects with a total score > 15 on the IRLS Rating Scale at baseline.
Beskrivning

5.Subjects with a total score > 15 on the IRLS Rating Scale at baseline.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449820
UMLS CUI [1,2]
C0681889
UMLS CUI [1,3]
C0035258
6.Subjects with RLS symptoms that cause significant sleep impairment based on clinical judgment and guided by subject response to question 4 of the IRLS Rating Scale (e.g., Ordinarily this will include a response of (3) severe or (4) very severe sleep disturbance) at the Baseline Visit.
Beskrivning

6.Subjects with RLS symptoms that cause significant sleep impairment based on clinical judgment and guided by subject response to question 4 of the IRLS Rating Scale (e.g., Ordinarily this will include a response of (3) severe or (4) very severe sleep disturbance) at the Baseline Visit.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0851578
7.Subjects must be experiencing RLS symptoms requiring treatment prior to bedtime, but no earlier than 5:00 PM.
Beskrivning

7.Subjects must be experiencing RLS symptoms requiring treatment prior to bedtime, but no earlier than 5:00 PM.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0332121
UMLS CUI [1,4]
C0521112
8. Subjects must have given written informed consent prior to any specific study procedures.
Beskrivning

8. Subjects must have given written informed consent prior to any specific study procedures.

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion criteria
Beskrivning

Exclusion criteria

Alias
UMLS CUI-1
C0680251
1. Subjects requiring treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).
Beskrivning

1. Subjects requiring treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0332169
2. Signs of secondary RLS (e.g. end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit).
Beskrivning

2. Signs of secondary RLS (e.g. end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit).

Datatyp

boolean

Alias
UMLS CUI [1]
C1261469
UMLS CUI [2]
C0022661
UMLS CUI [3]
C0162316
UMLS CUI [4]
C0032961
3. Subjects with a serum ferritin level of < 10 mcg/L (ng/mL) that has not resolved by the time of the Baseline Visit.
Beskrivning

3. Subjects with a serum ferritin level of < 10 mcg/L (ng/mL) that has not resolved by the time of the Baseline Visit.

Datatyp

boolean

Alias
UMLS CUI [1]
C0696113
4. Subjects having a clinically significant abnormal lab, ECG, or physical exam findings not resolved by time of baseline examinations. Abnormal 12-lead ECG findings include, but are not limited to the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias
Beskrivning

Laboratory test result abnormal; Clinical Significance | Electrocardiogram abnormal; Clinical Significance | Physical Examination; Abnormal; Clinical Significance | Myocardial Ischemia | Abnormal cardiac conduction; Clinical Significance | Cardiac Arrhythmia; Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0522055
UMLS CUI [2,2]
C2826293
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0205161
UMLS CUI [3,3]
C2826293
UMLS CUI [4]
C0151744
UMLS CUI [5,1]
C0232219
UMLS CUI [5,2]
C2826293
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C2826293
5. Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
Beskrivning

5. Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0236991
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C0035258
UMLS CUI [2,2]
C1457887
UMLS CUI [3]
C0027404
UMLS CUI [4,1]
C0851578
UMLS CUI [4,2]
C0037320
UMLS CUI [5]
C0037672
UMLS CUI [6]
C0236845
6. Subjects diagnosed with movement disorders (e.g. Parkinson’s Disease, dyskinesias, and dystonias).
Beskrivning

6. Subjects diagnosed with movement disorders (e.g. Parkinson’s Disease, dyskinesias, and dystonias).

Datatyp

boolean

Alias
UMLS CUI [1]
C0026650
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0013384
UMLS CUI [4]
C0013421
7. Subjects who have medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern. These may include, but are not limited to the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, pleuro-pulmonary fibrosis).
Beskrivning

7. Subjects who have medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1280519
UMLS CUI [1,3]
C0220825
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0036043
UMLS CUI [2,4]
C2699424
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0031117
UMLS CUI [5]
C0003873
UMLS CUI [6]
C0016053
UMLS CUI [7]
C0740482
UMLS CUI [8,1]
C0007222
UMLS CUI [8,2]
C0205082
UMLS CUI [9]
C0035078
UMLS CUI [10]
C0085605
UMLS CUI [11]
C0034069
8.Subjects with augmentation and/or end-of-dose rebound symptoms at baseline. Augmentation is defined as RLS symptoms that occurred while on treatment and occur >2 hours earlier than they did before, symptoms which are more severe than when not treated, symptoms which start after less time at rest than they did before treatment, or symptoms which involve other parts of the body, such as the arms or trunk.
Beskrivning

8.Subjects with augmentation and/or end-of-dose rebound symptoms at baseline.

Datatyp

boolean

Alias
UMLS CUI [1]
C1293122
UMLS CUI [2]
C0549262
UMLS CUI [3,1]
C0035258
UMLS CUI [3,2]
C1457887
UMLS CUI [3,3]
C2745955
UMLS CUI [4,1]
C0035258
UMLS CUI [4,2]
C1457887
UMLS CUI [4,3]
C0205082
UMLS CUI [5,1]
C0035258
UMLS CUI [5,2]
C1457887
UMLS CUI [5,3]
C0229962
9. Subjects with a history of alcohol or substance abuse within the past year.
Beskrivning

9. Subjects with a history of alcohol or substance abuse within the past year.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C1299544
10. Subjects with a diastolic blood pressure >110mmHg or <50mmHg or systolic blood pressure > 180mmHg or <90mmHg at the Screening or Baseline Visit.
Beskrivning

10. Subjects with a diastolic blood pressure >110mmHg or <50mmHg or systolic blood pressure > 180mmHg or <90mmHg at the Screening or Baseline Visit.

Datatyp

boolean

Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C0871470
11. Subjects taking any medication known to induce drowsiness, affect RLS or sleep and that have not been discontinued prior to the Baseline Visit. These medications include the following: - antidepressants (tricyclic antidepressants, noradrenaline [norepinephrine]/ serotonin re-uptake inhibitors, selective serotonin re-uptake inhibitors, bupropion), anticonvulsants, opioids (including propoxyphene and oxycodone), anxiolytics, all sedatives/hypnotics (including benzodiazepines), lithium, oral neuroleptics, stimulants (including methylphenidate), antipsychotics, dopamine agonists, dopamine antagonists, clonidine, and sedating antihistamines (e.g. chlorpheniramine, diphenhydramine, hydroxyzine) or any preparations containing these antihistamines - The minimum discontinuation period is generally 5 half lives or 7 consecutive evening/nights medication free, prior to baseline, whichever is the longer period. Exceptions to this general rule are as follows: fluoxetine, monoamine oxidase inhibitors: 4 weeks; depot neuroleptics: 12 weeks. - Exceptions may be made in the case of subjects who have been taking stable doses of one of the excluded medications for at least 3 months prior to study start and it can be confirmed that the medication is not affecting the subject’s symptoms of RLS or sleep. These exceptions will be made on a case by case basis after consultation with the sponsor. For these exceptions, the dose of the excluded medication must remain stable throughout the duration of the study.
Beskrivning

11. Subjects taking any medication known to induce drowsiness, affect RLS or sleep and that have not been discontinued prior to the Baseline Visit.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0013144
UMLS CUI [1,3]
C0035258
UMLS CUI [1,4]
C0392760
UMLS CUI [1,5]
C0013227
UMLS CUI [1,6]
C0013144
UMLS CUI [1,7]
C0035258
UMLS CUI [1,8]
C0037313
UMLS CUI [1,9]
C0457454
UMLS CUI [2]
C0003290
UMLS CUI [3]
C0162758
UMLS CUI [4]
C0003286
UMLS CUI [5,1]
C0242402
UMLS CUI [5,2]
C0033493
UMLS CUI [5,3]
C0030049
UMLS CUI [6]
C0040616
UMLS CUI [7,1]
C0020592
UMLS CUI [7,2]
C0005064
UMLS CUI [8]
C0023870
UMLS CUI [9,1]
C0040615
UMLS CUI [9,2]
C0442027
UMLS CUI [10,1]
C0304402
UMLS CUI [10,2]
C0025810
UMLS CUI [11]
C0040615
UMLS CUI [12]
C0178601
UMLS CUI [13]
C0242702
UMLS CUI [14]
C0009014
UMLS CUI [15,1]
C1955826
UMLS CUI [15,2]
C0008281
UMLS CUI [15,3]
C0012522
UMLS CUI [15,4]
C0020404
UMLS CUI [16,1]
C0457454
UMLS CUI [16,2]
C1524031
UMLS CUI [17]
C0016365
UMLS CUI [18]
C0026457
UMLS CUI [19,1]
C0040615
UMLS CUI [19,2]
C0086129
12. Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacin, cimetidine, fluvoxamine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to Baseline Visit. Subjects already on these agents may be enrolled, but must remain on stable doses of the agents from 7 days prior to Baseline Visit through to the follow-up visit at end of study.
Beskrivning

12. Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacin, cimetidine, fluvoxamine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to Baseline Visit.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0282402
UMLS CUI [1,2]
C2349954
UMLS CUI [2,1]
C0282402
UMLS CUI [2,2]
C0579004
UMLS CUI [3,1]
C0282402
UMLS CUI [3,2]
C1707811
UMLS CUI [4,1]
C1827504
UMLS CUI [4,2]
C0008809
UMLS CUI [4,3]
C0008783
UMLS CUI [4,4]
C0085228
UMLS CUI [4,5]
C0282402
UMLS CUI [5,1]
C1827490
UMLS CUI [5,2]
C0543414
UMLS CUI [5,3]
C0028978
13. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist.
Beskrivning

13. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0244821
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0178601
14. Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study.
Beskrivning

14. Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study.

Datatyp

boolean

Alias
UMLS CUI [1]
C0555008
UMLS CUI [2,1]
C0547101
UMLS CUI [2,2]
C4698019
UMLS CUI [2,3]
C0035171
UMLS CUI [3,1]
C0547101
UMLS CUI [3,2]
C4698019
UMLS CUI [3,3]
C0680104
15. Participation in any clinical drug or device trial in the one month prior to the Baseline Visit.
Beskrivning

15. Participation in any clinical drug or device trial in the one month prior to the Baseline Visit.

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
15. Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule or other study procedures.
Beskrivning

15. Subjects non-compliant with the visit schedule or other study procedures.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
17. Women who have a positive pregnancy test or who are lactating.
Beskrivning

17. Women who have a positive pregnancy test or who are lactating.

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C2828358
18. Women of child-bearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (e.g. Norplant).
Beskrivning

18. Women of child-bearing potential who are not practicing a clinically accepted method of contraception.

Datatyp

boolean

Alias
UMLS CUI [1]
C1960468
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C3176353
UMLS CUI [3]
C0029151
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0021900
UMLS CUI [6,1]
C0042241
UMLS CUI [6,2]
C3843423
UMLS CUI [6,3]
C0009653
UMLS CUI [7,1]
C0700589
UMLS CUI [7,2]
C1515119
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Similar models

Baseline - Eligibility Question

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
1. Subjects diagnosed with RLS using the RLS Diagnostic Clinical Interview and the International RLS Study Group (IRLSSG) Diagnostic Criteria at the Screening Visit.
Item
1. Subjects diagnosed with RLS using the RLS Diagnostic Clinical Interview and the International RLS Study Group (IRLSSG) Diagnostic Criteria at the Screening Visit.
boolean
C0035258 (UMLS CUI [1])
C1537061 (UMLS CUI [2,1])
C0035258 (UMLS CUI [2,2])
2. Subjects > 18 years and < 80 years of age
Item
2. Subjects > 18 years and < 80 years of age.
boolean
C0001779 (UMLS CUI [1])
3. Restless Legs Syndrome; Frequencies (time pattern) | Restless Legs Syndrome; Pharmaceutical Preparations; Washout Period
Item
3. Subjects have had RLS symptoms with a history of a minimum of 20 evening and nights of RLS episodes during the month prior to the Screening Visit (e.g., any combination of evenings and/or nights for >20 days). In the case of a subject currently receiving medication for the treatment of RLS at the Screening Visit, this inclusion criterion can be waived. However, the subject must discontinue and washout any previous medication for the treatment of RLS or sleep prior to the Baseline Visit (Day 0). The minimum discontinuation period for washout is generally 5 half-lives of the medication or 7 consecutive nights medication-free prior to baseline, whichever is the longer period.
boolean
C0035258 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0035258 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1710661 (UMLS CUI [2,3])
4.During the Washout and Screening Phase, RLS symptoms must be present for at least 4 of the last 7 evening and nights immediately prior to the Baseline Visit (e.g., any combination of evenings and/or nights for >4 days).
Item
4.During the Washout and Screening Phase, RLS symptoms must be present for at least 4 of the last 7 evening and nights immediately prior to the Baseline Visit (e.g., any combination of evenings and/or nights for >4 days).
boolean
C1710661 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0220908 (UMLS CUI [2,1])
C0035258 (UMLS CUI [2,2])
C0439603 (UMLS CUI [2,3])
5.Subjects with a total score > 15 on the IRLS Rating Scale at baseline.
Item
5.Subjects with a total score > 15 on the IRLS Rating Scale at baseline.
boolean
C0449820 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
6.Subjects with RLS symptoms that cause significant sleep impairment based on clinical judgment and guided by subject response to question 4 of the IRLS Rating Scale (e.g., Ordinarily this will include a response of (3) severe or (4) very severe sleep disturbance) at the Baseline Visit.
Item
6.Subjects with RLS symptoms that cause significant sleep impairment based on clinical judgment and guided by subject response to question 4 of the IRLS Rating Scale (e.g., Ordinarily this will include a response of (3) severe or (4) very severe sleep disturbance) at the Baseline Visit.
boolean
C0035258 (UMLS CUI [1,1])
C0851578 (UMLS CUI [1,2])
7.Subjects must be experiencing RLS symptoms requiring treatment prior to bedtime, but no earlier than 5:00 PM.
Item
7.Subjects must be experiencing RLS symptoms requiring treatment prior to bedtime, but no earlier than 5:00 PM.
boolean
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C0521112 (UMLS CUI [1,4])
8. Subjects must have given written informed consent prior to any specific study procedures.
Item
8. Subjects must have given written informed consent prior to any specific study procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
1. Subjects requiring treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).
Item
1. Subjects requiring treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).
boolean
C0035258 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0332169 (UMLS CUI [1,4])
2. Signs of secondary RLS (e.g. end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit).
Item
2. Signs of secondary RLS (e.g. end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit).
boolean
C1261469 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
C0162316 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
3. Subjects with a serum ferritin level of < 10 mcg/L (ng/mL) that has not resolved by the time of the Baseline Visit.
Item
3. Subjects with a serum ferritin level of < 10 mcg/L (ng/mL) that has not resolved by the time of the Baseline Visit.
boolean
C0696113 (UMLS CUI [1])
Laboratory test result abnormal; Clinical Significance | Electrocardiogram abnormal; Clinical Significance | Physical Examination; Abnormal; Clinical Significance | Myocardial Ischemia | Abnormal cardiac conduction; Clinical Significance | Cardiac Arrhythmia; Clinical Significance
Item
4. Subjects having a clinically significant abnormal lab, ECG, or physical exam findings not resolved by time of baseline examinations. Abnormal 12-lead ECG findings include, but are not limited to the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias
boolean
C0438215 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0522055 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C2826293 (UMLS CUI [3,3])
C0151744 (UMLS CUI [4])
C0232219 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0003811 (UMLS CUI [6,1])
C2826293 (UMLS CUI [6,2])
5. Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
Item
5. Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
boolean
C0236991 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0027404 (UMLS CUI [3])
C0851578 (UMLS CUI [4,1])
C0037320 (UMLS CUI [4,2])
C0037672 (UMLS CUI [5])
C0236845 (UMLS CUI [6])
6. Subjects diagnosed with movement disorders (e.g. Parkinson’s Disease, dyskinesias, and dystonias).
Item
6. Subjects diagnosed with movement disorders (e.g. Parkinson’s Disease, dyskinesias, and dystonias).
boolean
C0026650 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0013384 (UMLS CUI [3])
C0013421 (UMLS CUI [4])
7. Subjects who have medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern.
Item
7. Subjects who have medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern. These may include, but are not limited to the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, pleuro-pulmonary fibrosis).
boolean
C0012634 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0036043 (UMLS CUI [2,3])
C2699424 (UMLS CUI [2,4])
C0011849 (UMLS CUI [3])
C0031117 (UMLS CUI [4])
C0003873 (UMLS CUI [5])
C0016053 (UMLS CUI [6])
C0740482 (UMLS CUI [7])
C0007222 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0035078 (UMLS CUI [9])
C0085605 (UMLS CUI [10])
C0034069 (UMLS CUI [11])
8.Subjects with augmentation and/or end-of-dose rebound symptoms at baseline.
Item
8.Subjects with augmentation and/or end-of-dose rebound symptoms at baseline. Augmentation is defined as RLS symptoms that occurred while on treatment and occur >2 hours earlier than they did before, symptoms which are more severe than when not treated, symptoms which start after less time at rest than they did before treatment, or symptoms which involve other parts of the body, such as the arms or trunk.
boolean
C1293122 (UMLS CUI [1])
C0549262 (UMLS CUI [2])
C0035258 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C2745955 (UMLS CUI [3,3])
C0035258 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0035258 (UMLS CUI [5,1])
C1457887 (UMLS CUI [5,2])
C0229962 (UMLS CUI [5,3])
9. Subjects with a history of alcohol or substance abuse within the past year.
Item
9. Subjects with a history of alcohol or substance abuse within the past year.
boolean
C0085762 (UMLS CUI [1,1])
C1299544 (UMLS CUI [1,2])
10. Subjects with a diastolic blood pressure >110mmHg or <50mmHg or systolic blood pressure > 180mmHg or <90mmHg at the Screening or Baseline Visit.
Item
10. Subjects with a diastolic blood pressure >110mmHg or <50mmHg or systolic blood pressure > 180mmHg or <90mmHg at the Screening or Baseline Visit.
boolean
C0428883 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
11. Subjects taking any medication known to induce drowsiness, affect RLS or sleep and that have not been discontinued prior to the Baseline Visit.
Item
11. Subjects taking any medication known to induce drowsiness, affect RLS or sleep and that have not been discontinued prior to the Baseline Visit. These medications include the following: - antidepressants (tricyclic antidepressants, noradrenaline [norepinephrine]/ serotonin re-uptake inhibitors, selective serotonin re-uptake inhibitors, bupropion), anticonvulsants, opioids (including propoxyphene and oxycodone), anxiolytics, all sedatives/hypnotics (including benzodiazepines), lithium, oral neuroleptics, stimulants (including methylphenidate), antipsychotics, dopamine agonists, dopamine antagonists, clonidine, and sedating antihistamines (e.g. chlorpheniramine, diphenhydramine, hydroxyzine) or any preparations containing these antihistamines - The minimum discontinuation period is generally 5 half lives or 7 consecutive evening/nights medication free, prior to baseline, whichever is the longer period. Exceptions to this general rule are as follows: fluoxetine, monoamine oxidase inhibitors: 4 weeks; depot neuroleptics: 12 weeks. - Exceptions may be made in the case of subjects who have been taking stable doses of one of the excluded medications for at least 3 months prior to study start and it can be confirmed that the medication is not affecting the subject’s symptoms of RLS or sleep. These exceptions will be made on a case by case basis after consultation with the sponsor. For these exceptions, the dose of the excluded medication must remain stable throughout the duration of the study.
boolean
C0013227 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,5])
C0013144 (UMLS CUI [1,6])
C0035258 (UMLS CUI [1,7])
C0037313 (UMLS CUI [1,8])
C0457454 (UMLS CUI [1,9])
C0003290 (UMLS CUI [2])
C0162758 (UMLS CUI [3])
C0003286 (UMLS CUI [4])
C0242402 (UMLS CUI [5,1])
C0033493 (UMLS CUI [5,2])
C0030049 (UMLS CUI [5,3])
C0040616 (UMLS CUI [6])
C0020592 (UMLS CUI [7,1])
C0005064 (UMLS CUI [7,2])
C0023870 (UMLS CUI [8])
C0040615 (UMLS CUI [9,1])
C0442027 (UMLS CUI [9,2])
C0304402 (UMLS CUI [10,1])
C0025810 (UMLS CUI [10,2])
C0040615 (UMLS CUI [11])
C0178601 (UMLS CUI [12])
C0242702 (UMLS CUI [13])
C0009014 (UMLS CUI [14])
C1955826 (UMLS CUI [15,1])
C0008281 (UMLS CUI [15,2])
C0012522 (UMLS CUI [15,3])
C0020404 (UMLS CUI [15,4])
C0457454 (UMLS CUI [16,1])
C1524031 (UMLS CUI [16,2])
C0016365 (UMLS CUI [17])
C0026457 (UMLS CUI [18])
C0040615 (UMLS CUI [19,1])
C0086129 (UMLS CUI [19,2])
12. Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacin, cimetidine, fluvoxamine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to Baseline Visit.
Item
12. Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacin, cimetidine, fluvoxamine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to Baseline Visit. Subjects already on these agents may be enrolled, but must remain on stable doses of the agents from 7 days prior to Baseline Visit through to the follow-up visit at end of study.
boolean
C0282402 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0282402 (UMLS CUI [2,1])
C0579004 (UMLS CUI [2,2])
C0282402 (UMLS CUI [3,1])
C1707811 (UMLS CUI [3,2])
C1827504 (UMLS CUI [4,1])
C0008809 (UMLS CUI [4,2])
C0008783 (UMLS CUI [4,3])
C0085228 (UMLS CUI [4,4])
C0282402 (UMLS CUI [4,5])
C1827490 (UMLS CUI [5,1])
C0543414 (UMLS CUI [5,2])
C0028978 (UMLS CUI [5,3])
13. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist.
Item
13. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist.
boolean
C1744706 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0178601 (UMLS CUI [2,2])
14. Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study.
Item
14. Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study.
boolean
C0555008 (UMLS CUI [1])
C0547101 (UMLS CUI [2,1])
C4698019 (UMLS CUI [2,2])
C0035171 (UMLS CUI [2,3])
C0547101 (UMLS CUI [3,1])
C4698019 (UMLS CUI [3,2])
C0680104 (UMLS CUI [3,3])
15. Participation in any clinical drug or device trial in the one month prior to the Baseline Visit.
Item
15. Participation in any clinical drug or device trial in the one month prior to the Baseline Visit.
boolean
C2348568 (UMLS CUI [1])
15. Subjects non-compliant with the visit schedule or other study procedures.
Item
15. Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule or other study procedures.
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
17. Women who have a positive pregnancy test or who are lactating.
Item
17. Women who have a positive pregnancy test or who are lactating.
boolean
C0032961 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
18. Women of child-bearing potential who are not practicing a clinically accepted method of contraception.
Item
18. Women of child-bearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (e.g. Norplant).
boolean
C1960468 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C3176353 (UMLS CUI [2,2])
C0029151 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6,1])
C3843423 (UMLS CUI [6,2])
C0009653 (UMLS CUI [6,3])
C0700589 (UMLS CUI [7,1])
C1515119 (UMLS CUI [7,2])
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