ID

25686

Description

Study part: Eligibility Question. A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Clinicaltrials.gov Identifier: NCT00355641. 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. Study ID: 101468/206. Clinical Study ID: 101468/206.

Keywords

Versions (1)
  1. 9/9/17 9/9/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 9, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Question Ropinirole Restless Legs Syndrom NCT00355641

English

Eligibility Question

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Question
ELIGIBILITY QUESTION (ELIG)
Description

ELIGIBILITY QUESTION (ELIG)

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

Eligibility Question

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Inclusion Criteria 1
Description

1. Subjects in North America ≥18 years of age who a. Had successfully completed one of the following parent studies: 101468/205, ROX104805; OR b. Had a diagnosis of primary RLS using the IRSSG Diagnostic Criteria, experienced RLS symptoms during both the evening (before 8 PM) and night- time, and had a total score ≥15 on the IRLS Rating Scale at Baseline. Subjects must have had a history of a minimum of 20 evenings/nights of RLS episodes per month (e.g., any combination of evenings and/or nights for ≥ 20 days). During Screening/Washout, RLS symptoms must have been present for at least 4 of 7 evenings/nights immediately prior to the Baseline Visit (e.g., any combination of evenings and/or nights for ≥ 4 days).

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0035258
Inclusion Criteria 2
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Exclusion Criteria 1
Description

1. Subjects who had any medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that presented a safety concern. These may have included, but were 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.

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0011849
UMLS CUI [1,3]
C0031117
Exclusion Criteria 2
Description

2. Subjects who had clinically significant abnormal laboratory or ECG findings not resolved at time of baseline examinations. Abnormal 12-lead ECG findings included, but were not limited to the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias.

Data type

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0013798
Exclusion Criteria 3
Description

3. Subjects with a diastolic blood pressure ≥ 110mmHg or ≤ 50mmHg or systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at the Screening or Baseline visit.

Data type

boolean

Alias
UMLS CUI [1]
C0005823
Exclusion Criteria 4
Description

4. Subjects with a history of augmentation and/or end-of-dose rebound symptoms. • Augmentation was defined as RLS symptoms that occurred while on treatment and occurred ≥ 2 hours earlier than they did previously, symptoms which were more severe than when not treated, symptoms which started after less time at rest than they did before treatment, or symptoms which involved other parts of the body, such as the arms or trunk. • End-of-dose rebound was defined as a re-emergence of RLS symptoms in the early morning the day after taking the dose of RLS medication.

Data type

boolean

Alias
UMLS CUI [1]
C0034897
Exclusion Criteria 5
Description

5. Subjects who had exhibited intolerance to ropinirole.

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0244821
Exclusion Criteria 6
Description

6. For subjects entering Study 206, certain medications must have been discontinued prior to entering the study. The following medications are prohibited for the duration of the study period which is up to and including the Follow-up visit: • dopamine agonists (including ropinirole IR), dopamine antagonists (e.g., typical neuroleptics, metoclopromide), levodopa/carbidopa The minimum discontinuation period was generally 5 half-lives or 7 consecutive evening/nights medication-free, prior to baseline, whichever was the longer period. If the subject required longer than 2 weeks following the Follow-up visit of the parent study to complete the washout, GSK must have been consulted for further instructions.

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0178601
Exclusion Criteria 7
Description

7. Other medications, including those with partial dopaminergic activity (e.g., atypical antipsychotics, certain antidepressants such as bupropion, tricyclic antidepressants and monoamine oxidase inhibitors) may have additive activity with ropinirole and were to be used with caution in subjects taking ropinirole. For subjects on stable doses, these agents may have been permitted; however, it was recommended that the dose of the medication remain stable throughout the duration of the study.

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0178601
Exclusion Criteria 8
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0555008
UMLS CUI [2]
C0547101
Exclusion Criteria 9
Description

9. Women who had a positive pregnancy test.

Data type

boolean

Alias
UMLS CUI [1]
C0240802
Exclusion Criteria 10
Description

10. Women of child-bearing potential who were not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, intrauterine device (IUD), diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (e.g. Norplant).

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
Exclusion Criteria 11
Description

11. Subjects who suffered from a primary sleep disorder other than RLS that may have significantly affected the symptoms of RLS (e.g., narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).

Data type

boolean

Alias
UMLS CUI [1]
C0236991
Exclusion Criteria 12
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0026650
UMLS CUI [1,2]
C0030567
UMLS CUI [1,3]
C0013384
UMLS CUI [1,4]
C0013421
Exclusion Criteria 13
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1536279
Exclusion Criteria 14
Description

14. Subjects who required treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).

Data type

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0439548
Exclusion Criteria 15
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0038586
Exclusion Criteria 16
Description

16. Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule or other study procedures.

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria 17
Description

17. Participation in any clinical drug or device trial (other than Study 101468/205 or ROX104805) in the one month prior to the Baseline Visit.

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Do not admit the subject into this study if any Inclusion / Exclusion criteria is checked unless an exception has been granted by the GSK Medical Monitor and subject is continuing in the study. Please clarify the exemption(s) below
Description

exemption

Data type

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348482
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Similar models

Eligibility Question

1 forms
  1. StudyEvent: ODM
    1. Eligibility Question
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ELIGIBILITY QUESTION (ELIG)
C1516637 (UMLS CUI-1)
Eligibility Question
Item
1. Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age; Study Subject Participation Status; Restless Legs Syndrome
Item
Inclusion Criteria 1
boolean
C0001779 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0035258 (UMLS CUI [3])
informed consent
Item
Inclusion Criteria 2
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Comorbidity diabetes peripheral neuropathy
Item
Exclusion Criteria 1
boolean
C0009488 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0031117 (UMLS CUI [1,3])
Laboratory abnormalities; ECG
Item
Exclusion Criteria 2
boolean
C1853129 (UMLS CUI [1])
C0013798 (UMLS CUI [2])
Blood pressure
Item
Exclusion Criteria 3
boolean
C0005823 (UMLS CUI [1])
Recurrence
Item
Exclusion Criteria 4
boolean
C0034897 (UMLS CUI [1])
intolerance ropinirole
Item
Exclusion Criteria 5
boolean
C1744706 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
concomitant medication dopamine agonists
Item
Exclusion Criteria 6
boolean
C2347852 (UMLS CUI [1,1])
C0178601 (UMLS CUI [1,2])
concomitant medication dopamine agonists
Item
Exclusion Criteria 7
boolean
C2347852 (UMLS CUI [1,1])
C0178601 (UMLS CUI [1,2])
Night workers; sleeping habits
Item
Exclusion Criteria 8
boolean
C0555008 (UMLS CUI [1])
C0547101 (UMLS CUI [2])
positive pregnancy test
Item
Exclusion Criteria 9
boolean
C0240802 (UMLS CUI [1])
Women of child-bearing potential; contraceptive methods
Item
Exclusion Criteria 10
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
primary sleep disorder
Item
Exclusion Criteria 11
boolean
C0236991 (UMLS CUI [1])
movement disorders Parkinsons disease dyskinesias dystonias
Item
Exclusion Criteria 12
boolean
C0026650 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0013384 (UMLS CUI [1,3])
C0013421 (UMLS CUI [1,4])
Secondary restless legs syndrome
Item
Exclusion Criteria 13
boolean
C1536279 (UMLS CUI [1])
Restless Legs Syndrome symptoms day time
Item
Exclusion Criteria 14
boolean
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0439548 (UMLS CUI [1,3])
Substance abuse disorder
Item
Exclusion Criteria 15
boolean
C0038586 (UMLS CUI [1])
compliance behavior
Item
Exclusion Criteria 16
boolean
C1321605 (UMLS CUI [1])
Study subject participation status
Item
Exclusion Criteria 17
boolean
C2348568 (UMLS CUI [1])
exemption
Item
Do not admit the subject into this study if any Inclusion / Exclusion criteria is checked unless an exception has been granted by the GSK Medical Monitor and subject is continuing in the study. Please clarify the exemption(s) below
text
C1516637 (UMLS CUI [1,1])
C2348482 (UMLS CUI [1,2])
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