A Fixed Dose, Dose Response Study for Ropinirole Prolonge... | NCT01485172 | Trialant
NCT01485172
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jun 20, 2018Actual
Enrollment
186Actual
Phase
Phase 4
Conditions
Parkinson Disease
Interventions
ropinirole monotherapy
placebo monotherapy
Countries
United States
Estonia
Russia
Slovakia
South Korea
Protocol Section
Identification Module
NCT ID
NCT01485172
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
111662
Secondary IDs
Not provided
Brief Title
A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease
Official Title
A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release (PR) in Patients With Early Stage Parkinson's Disease
Acronym
TANDEM-662
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jun 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 31, 2012Actual
Primary Completion Date
Apr 30, 2014Actual
Completion Date
Apr 30, 2014Actual
First Submitted Date
Dec 1, 2011
First Submission Date that Met QC Criteria
Dec 1, 2011
First Posted Date
Dec 5, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 18, 2014
Results First Submitted that Met QC Criteria
Jan 29, 2015
Results First Posted Date
Feb 2, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 18, 2018
Last Update Posted Date
Jun 20, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a fixed dose, dose response study to characterize the dose response for ropinirole PR in early stage PD patients (Hoehn & Yahr stages I-III). After screening and baseline assessments, subjects will be randomized to one of six final target treatment groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening period, an up-titration period, a maintenance period, a down titration period and a follow up period. This study utilizes change from baseline in the UPDRS motor score as the primary endpoint, in line with that used in the ropinirole PR monotherapy pivotal study (SK&F101468/168). Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.
Detailed Description
Not provided
Conditions Module
Conditions
Parkinson Disease
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
186Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ropinirole
Experimental
ropinirole 2, 4, 8, 12, or 24 mg/day
Drug: ropinirole monotherapy
placebo
Placebo Comparator
placebo comparator 2, 4, 8, 12, or 24 mg/day
Drug: ropinirole monotherapy
Drug: placebo monotherapy
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ropinirole monotherapy
Drug
ropinirole as monotherapy in Parkinson's disease
placebo
ropinirole
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. One of the six features include the Part III - Motor Examination where scores can range 0-108 where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. The least squares(LS) means were estimated using the mixed model repeated measures(MMRM) adjusting for BL UPDRS motor score and race(white versus other) or by using the non-parametric rank analysis of covariance(ANCOVA).
Baseline and Week 4 of the Maintenance Period (Study Week 17)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score
The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of idiopathic Parkinson's disease (according to modified Hoehn & Yahr criteria Stages I-III.)
Subjects aged 30 years or greater at screening. Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for at least one month prior to randomization and one month following completion of the study. Acceptable contraceptive methods include abstinence, oral contraception, injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, surgical sterilisation, male partner sterilization, intrauterine device [IUD], or double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository.
A baseline UPDRS motor score of at least 10.
Limited prior exposure to low or moderate doses of L-DOPA (up to 3 months in total) or dopamine agonists including ropinirole (up to 6 months in total) is allowed provided treatment is discontinued for a minimum of 4 weeks prior to screening.
Provide written informed consent for this study.
Be willing and able to comply with study procedures.
Exclusion Criteria:
Subjects with Parkinson's disease in whom dopaminergic therapy is not warranted at the time of screening.
Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, render the subject unsuitable for the study (e.g., psychiatric, haematological, renal, hepatic, endocrinology, neurological [other than Parkinson's disease], cardiovascular, or active malignancy [other than basal cell carcinoma]).
Subjects with crippling degenerative arthritis or other physical or mental conditions precluding accurate assessment of efficacy or safety.
Subjects with prior or current major psychosis (e.g., schizophrenia or psychotic depression) e.g. scoring 3 or 4 on UPDRS item 2 [thought disorder] or item 3 [depression].
Subjects with severe clinical dementia e.g. scoring 3 or 4 on UPDRS item 1 [mentation].
Subjects with severe dizziness or fainting due to postural hypotension on standing.
Subjects with a personal history of melanoma.
Subjects with clinically significant abnormalities in laboratory or ECG tests at Screening. If findings are outside the normal range and the subject is included, it must be documented by the investigator that the findings are not of clinical significance.
Subjects diagnosed with an impulse control disorder. The modified MIDI will be conducted at screening. Subjects who score positive for this screen must be referred to a specialist for diagnostic evaluation prior to enrolling (screening) in the study.
Subjects with an active suicidal plan/intent or have had active suicidal thoughts in the past 6 months. Subjects with a history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt.
Current alcohol or drug dependence.
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 long-term dosing with ropinirole.
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 baseline (randomization).
Subjects on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to baseline (randomization) through the end of the treatment period. Smokers should maintain normal smoking habit.
Women who are pregnant or breast-feeding.
Use of an investigational drug from 30 days or 5 half-lives (which ever is longer) prior to baseline (randomization) to the end of the treatment period.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
30 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Fountain Valley
California
92708
United States
GSK Investigational Site
References Module
Citations
Not provided
See Also Links
Label
URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
After Screening, par. underwent a 13 Week Up-Titration Period until reaching their target dose then continued on their target dose during a 4 Week Maintenance Period up to Week 17. All par. underwent a 1 Week Down-Titration Period and then a Follow-Up Visit 1-2 Weeks after receiving the last dose of treatment.
Recruitment Details
Eligible participants (par.) were diagnosed with early stage Parkinson's disease (according to modified Hoehn and Yahr criteria Stages I-III) and randomized at Screening into one of six treatment arms to receive placebo or ropinirole Prolonged Release (PR) tablets.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
FG001
Treatment Group B: 2 mg/Day
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Poland
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
placebo monotherapy
Drug
placebo as monotherapy in Parkinson's disease
placebo
Baseline and Week 4 of the Maintenance Period (Study Week 17)
Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Motor Score
The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Baseline and Week 4 of the Maintenance Period (Study Week 17)
Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Parts II and III Combined
The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date.
Baseline and Week 4 of the Maintenance Period (Study Week 17)
Responder Rate Defined as Participants With a >=30% Reduction in Baseline UPDRS Motor Score
The responder rate is defined as the percentage of participants with a greater than or equal to (>=)30% reduction in their individual Baseline UPDRS motor score at Week 4 of the Maintenance Period (Study Week 17). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change From Baseline in UPDRS Parts II and III Combined
The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change From Baseline in UPDRS Activities of Daily Living
The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The higher score indicates the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change From Baseline in the Total UPDRS Score (Parts I-III)
The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scores mentation, behavior and mood and scores can range from 0-16. The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and scores range from 0-108. The total UPDRS (Part I + II + III) scores can range from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change From Baseline in the UPDRS Part I (Mentation)
The UPDRS Part I scores mentation, behavior and mood as determined by a physician and participants were tested during the "on" phase of Parkinson's. This component of the UPDRS is the total score for 4 items (the items 1- 4 include intellectual impairment, thought disorder, motivation/initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician where 16 indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component will also be missing. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Baseline and Week 4 of the Maintenance Period (Study Week 17)
Responder Rate According to the Clinical Global Impression - Global Improvement (CGI-I) Scale
The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved", 4 = "no change", 5 = "minimally worse, 6 = "much worse", and 7 = "very much worse". The responder rate is defined as the percentage of participants with a score of 1 or 2.
Week 4 of the Maintenance Period (Study Week 17)
Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy
The percentage of participants who withdrew from the study due to lack of efficacy as defined by either the participant or the investigator is presented here.
Up to Week 4 of the Maintenance Period (Study Week 17)
Pasadena
California
91105
United States
GSK Investigational Site
Reseda
California
91355
United States
GSK Investigational Site
Torrance
California
90505
United States
GSK Investigational Site
Ventura
California
93003
United States
GSK Investigational Site
Boca Raton
Florida
33486
United States
GSK Investigational Site
Tampa
Florida
33612
United States
GSK Investigational Site
Augusta
Georgia
30912
United States
GSK Investigational Site
Forest Hills
New York
11375
United States
GSK Investigational Site
Cincinnati
Ohio
45227
United States
GSK Investigational Site
Richmond
Virginia
23249
United States
GSK Investigational Site
Tallinn
10138
Estonia
GSK Investigational Site
Tallinn
13419
Estonia
GSK Investigational Site
Tartu
51014
Estonia
GSK Investigational Site
Chelyabinsk
454136
Russia
GSK Investigational Site
Kazan'
420012
Russia
GSK Investigational Site
Krasnoyarsk
660022
Russia
GSK Investigational Site
Kursk
305007
Russia
GSK Investigational Site
Novosibirsk
630091
Russia
GSK Investigational Site
Omsk
644033
Russia
GSK Investigational Site
Perm
614990
Russia
GSK Investigational Site
Saint Petersburg
194044
Russia
GSK Investigational Site
Saratov
410012
Russia
GSK Investigational Site
Smolensk
214019
Russia
GSK Investigational Site
Ufa
450000
Russia
GSK Investigational Site
Yekaterinburg
620102
Russia
GSK Investigational Site
Banská Bystrica
974 04
Slovakia
GSK Investigational Site
Bratislava
813 69
Slovakia
GSK Investigational Site
Bratislava
831 03
Slovakia
GSK Investigational Site
Busan
602-715
South Korea
GSK Investigational Site
Donggu Gwangju
501757
South Korea
GSK Investigational Site
Seoul
138-736
South Korea
GSK Investigational Site
Seoul
152-703
South Korea
GSK Investigational Site
Sungnam -Gyeonggi-do
463707
South Korea
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
FG002
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
FG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
FG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
FG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
FG00040 subjects
FG00113 subjects
FG00241 subjects
FG00340 subjects
FG00439 subjects
FG00513 subjects
COMPLETED
FG00033 subjects
FG00112 subjects
FG00234 subjects
FG00332 subjects
FG00434 subjects
FG0059 subjects
NOT COMPLETED
FG0007 subjects
FG0011 subjects
FG0027 subjects
FG0038 subjects
FG0045 subjects
FG0054 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG0041 subjects
FG0052 subjects
Lack of Efficacy
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0035 subjects
FG004
Protocol defined stopping criteria
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
BG001
Treatment Group B: 2 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
BG002
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
BG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
BG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
BG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00040
BG00113
BG00241
BG00340
BG00439
BG00513
BG006186
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00063.1± 8.82
BG00158.2± 11.12
BG00262.1± 11.38
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00017
BG0015
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
African American/African Heritage
Title
Measurements
BG0002
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. One of the six features include the Part III - Motor Examination where scores can range 0-108 where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. The least squares(LS) means were estimated using the mixed model repeated measures(MMRM) adjusting for BL UPDRS motor score and race(white versus other) or by using the non-parametric rank analysis of covariance(ANCOVA).
Intent to Treat (ITT) Population: all randomized subjects who received at least one dose of study medication, had a Baseline efficacy assessment for the specific outcome, and had at least one respective efficacy outcome assessment collected after randomization (Baseline) visit, i.e. had at least one respective Post-Baseline efficacy assessment.
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and Week 4 of the Maintenance Period (Study Week 17)
ID
Title
Description
OG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG001
Treatment Group B: 2 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG002
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Units
Counts
Participants
OG00033
OG00113
OG00234
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.91(-4.15 to 0.34)
OG001-1.58(-5.02 to 1.86)
OG002-2.76(-5.04 to -0.49)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.864
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
0.33
2-Sided
95
-3.41
4.05
Superiority or Other
OG000
OG002
Mixed Models Analysis
Secondary
Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score
The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
Posted
Number
Participants
Baseline and Week 4 of the Maintenance Period (Study Week 17)
ID
Title
Description
OG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG001
Treatment Group B: 2 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG002
Secondary
Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Motor Score
The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
Posted
Number
Participants
Baseline and Week 4 of the Maintenance Period (Study Week 17)
ID
Title
Description
OG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG001
Treatment Group B: 2 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG002
Secondary
Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Parts II and III Combined
The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date.
ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
Posted
Number
Participants
Baseline and Week 4 of the Maintenance Period (Study Week 17)
ID
Title
Description
OG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG001
Treatment Group B: 2 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Secondary
Responder Rate Defined as Participants With a >=30% Reduction in Baseline UPDRS Motor Score
The responder rate is defined as the percentage of participants with a greater than or equal to (>=)30% reduction in their individual Baseline UPDRS motor score at Week 4 of the Maintenance Period (Study Week 17). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
Posted
Number
Percentage of Participants
Baseline and Week 4 of the Maintenance Period (Study Week 17)
ID
Title
Description
OG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG001
Treatment Group B: 2 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Secondary
Change From Baseline in UPDRS Parts II and III Combined
The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
Posted
Least Squares Mean
95% Confidence Interval
Scores on a scale
Baseline and Week 4 of the Maintenance Period (Study Week 17)
ID
Title
Description
OG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG001
Treatment Group B: 2 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Secondary
Change From Baseline in UPDRS Activities of Daily Living
The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The higher score indicates the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and Week 4 of the Maintenance Period (Study Week 17)
ID
Title
Description
OG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG001
Treatment Group B: 2 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Secondary
Change From Baseline in the Total UPDRS Score (Parts I-III)
The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scores mentation, behavior and mood and scores can range from 0-16. The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and scores range from 0-108. The total UPDRS (Part I + II + III) scores can range from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and Week 4 of the Maintenance Period (Study Week 17)
ID
Title
Description
OG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG001
Treatment Group B: 2 mg/Day
Secondary
Change From Baseline in the UPDRS Part I (Mentation)
The UPDRS Part I scores mentation, behavior and mood as determined by a physician and participants were tested during the "on" phase of Parkinson's. This component of the UPDRS is the total score for 4 items (the items 1- 4 include intellectual impairment, thought disorder, motivation/initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician where 16 indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component will also be missing. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and Week 4 of the Maintenance Period (Study Week 17)
ID
Title
Description
OG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG001
Treatment Group B: 2 mg/Day
Secondary
Responder Rate According to the Clinical Global Impression - Global Improvement (CGI-I) Scale
The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved", 4 = "no change", 5 = "minimally worse, 6 = "much worse", and 7 = "very much worse". The responder rate is defined as the percentage of participants with a score of 1 or 2.
ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
Posted
Number
Percentage of participants
Week 4 of the Maintenance Period (Study Week 17)
ID
Title
Description
OG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG001
Treatment Group B: 2 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Secondary
Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy
The percentage of participants who withdrew from the study due to lack of efficacy as defined by either the participant or the investigator is presented here.
ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
Posted
Number
Percentage of participants
Up to Week 4 of the Maintenance Period (Study Week 17)
ID
Title
Description
OG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG001
Treatment Group B: 2 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG002
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Time Frame
Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
Description
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
0
40
17
40
EG001
Treatment Group B: 2 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
0
13
5
13
EG002
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
1
41
18
41
EG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
0
40
24
40
EG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
2
39
18
39
EG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
0
13
7
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cerebral infarction
Nervous system disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG0030 affected40 at risk
EG0041 affected39 at risk
EG0050 affected13 at risk
Coronary artery disease
Cardiac disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Chest pain
General disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0021 affected41 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Somnolence
Nervous system disorders
MedRA
Systematic Assessment
EG0002 affected40 at risk
EG0012 affected13 at risk
EG0025 affected41 at risk
EG0034 affected40 at risk
EG0043 affected39 at risk
EG0051 affected13 at risk
Headache
Nervous system disorders
MedRA
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected13 at risk
EG0024 affected41 at risk
EG003
Dizziness
Nervous system disorders
MedRA
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected13 at risk
EG0022 affected41 at risk
EG003
Sudden onset of sleep
Nervous system disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0022 affected41 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedRA
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Tremor
Nervous system disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Dizziness postural
Nervous system disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Syncope
Nervous system disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Nausea
Gastrointestinal disorders
MedRA
Systematic Assessment
EG0003 affected40 at risk
EG0011 affected13 at risk
EG0026 affected41 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedRA
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected13 at risk
EG0020 affected41 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedRA
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected13 at risk
EG0021 affected41 at risk
EG003
Vomiting
Gastrointestinal disorders
MedRA
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected13 at risk
EG0022 affected41 at risk
EG003
Constipation
Gastrointestinal disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0021 affected41 at risk
EG003
Nasopharyngitis
Infections and infestations
MedRA
Systematic Assessment
EG0003 affected40 at risk
EG0010 affected13 at risk
EG0021 affected41 at risk
EG003
Pyelonephritis chronic
Infections and infestations
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected13 at risk
EG0020 affected41 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedRA
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected13 at risk
EG0022 affected41 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Hypertension
Vascular disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0022 affected41 at risk
EG003
Labile blood pressure
Vascular disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedRA
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Blood creatine
Investigations
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0021 affected41 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedRA
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Confusional state
Psychiatric disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Libido increased
Psychiatric disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Asthenia
General disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected13 at risk
EG0021 affected41 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Skeletal injury
Injury, poisoning and procedural complications
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Dysplastic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected13 at risk
EG0020 affected41 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected13 at risk
EG0020 affected41 at risk
EG003
Palpitations
Cardiac disorders
MedRA
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected13 at risk
EG0020 affected41 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
ID
Term
D010300
Parkinson Disease
Ancestor Terms
ID
Term
D020734
Parkinsonian Disorders
D001480
Basal Ganglia Diseases
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D009069
Movement Disorders
D000080874
Synucleinopathies
D019636
Neurodegenerative Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
1 subjects
FG0050 subjects
1 subjects
FG0050 subjects
0 subjects
FG0051 subjects
1 subjects
FG0050 subjects
1 subjects
FG0051 subjects
60.3
± 11.72
BG00461.7± 10.78
BG00562.5± 12.88
BG00661.6± 10.85
16
BG00328
BG00419
BG0056
BG00691
Male
BG00023
BG0018
BG00225
BG00312
BG00420
BG0057
BG00695
0
BG0030
BG0040
BG0050
BG0062
Asian - East Asian
Title
Measurements
BG0002
BG0010
BG0021
BG0035
BG0042
BG0051
BG00611
Asian - Japanese
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0061
Asian - South East Asian Heritage
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0061
White - White/Caucasian
Title
Measurements
BG00036
BG00113
BG00239
BG00334
BG00436
BG00512
BG006170
Missing
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0061
OG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
33
OG00434
OG00510
-4.31
(-6.48 to -2.15)
OG004-4.07(-6.32 to -1.82)
OG005-2.83(-6.61 to 0.95)
0.539
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-0.85
2-Sided
95
-3.61
1.90
Superiority or Other
OG000
OG003
Mixed Models Analysis
0.091
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-2.40
2-Sided
95
-5.21
0.39
Superiority or Other
OG000
OG004
Mixed Models Analysis
0.124
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-2.16
2-Sided
95
-4.93
0.60
Superiority or Other
OG000
OG005
Mixed Models Analysis
0.658
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-0.92
2-Sided
95
-5.04
3.19
Superiority or Other
OG000
OG001
ANCOVA
0.439
P-values are from nonparametric rank ANCOVA without stratifications.
95
Superiority or Other
OG000
OG002
ANCOVA
0.177
P-values are from nonparametric rank ANCOVA without stratifications.
95
Superiority or Other
OG000
OG003
ANCOVA
0.060
P-values are from nonparametric rank ANCOVA without stratifications.
95
Superiority or Other
OG000
OG004
ANCOVA
0.047
P-values are from nonparametric rank ANCOVA without stratifications.
95
Superiority or Other
OG000
OG005
ANCOVA
0.407
P-values are from nonparametric rank ANCOVA without stratifications.
95
Superiority or Other
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Units
Counts
Participants
OG00035
OG00113
OG00235
OG00333
OG00434
OG00510
Title
Denominators
Categories
Title
Measurements
OG0009
OG0016
OG00214
OG00316
OG00419
OG0055
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Generalized Estimating Equations model
0.397
Odds Ratio (OR)
2.003
2-Sided
95
0.40
9.98
Superiority or Other
OG000
OG002
Generalized Estimating Equations model
0.131
Odds Ratio (OR)
2.242
2-Sided
95
0.79
6.40
Superiority or Other
OG000
OG003
Generalized Estimating Equations model
0.018
Odds Ratio (OR)
3.515
2-Sided
95
1.25
9.92
Superiority or Other
OG000
OG004
Generalized Estimating Equations model
0.020
Odds Ratio (OR)
3.607
95
1.22
10.64
Superiority or Other
OG000
OG005
Generalized Estimating Equations model
0.202
Odds Ratio (OR)
2.679
2-Sided
95
0.59
12.16
Superiority or Other
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Units
Counts
Participants
OG00035
OG00113
OG00235
OG00333
OG00434
OG00510
Title
Denominators
Categories
Title
Measurements
OG0005
OG0013
OG0027
OG0037
OG0049
OG0052
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Generalized Estimating Equations model
0.662
Odds Ratio (OR)
1.544
95
0.22
10.84
Superiority or Other
OG000
OG002
Generalized Estimating Equations model
0.557
Odds Ratio (OR)
1.485
2-Sided
95
0.40
5.55
Superiority or Other
OG000
OG003
Generalized Estimating Equations model
0.347
Odds Ratio (OR)
1.855
2-Sided
95
0.51
6.72
Superiority or Other
OG000
OG004
Generalized Estimating Equations model
0.379
Odds Ratio (OR)
1.776
2-Sided
95
0.49
6.38
Superiority or Other
OG000
OG005
Generalized Estimating Equations model
0.851
Odds Ratio (OR)
1.194
2-Sided
95
0.19
7.63
Superiority or Other
OG002
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Units
Counts
Participants
OG00035
OG00113
OG00235
OG00333
OG00434
OG00510
Title
Denominators
Categories
Title
Measurements
OG0006
OG0013
OG0027
OG00310
OG00412
OG0055
OG002
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Units
Counts
Participants
OG00035
OG00113
OG00235
OG00333
OG00434
OG00510
Title
Denominators
Categories
Title
Measurements
OG00018
OG00131
OG00223
OG00330
OG00438
OG00531
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Generalized Estimating Equations model
0.540
Odds Ratio (OR)
1.591
2-Sided
95
0.36
7.03
Superiority or Other
OG000
OG002
Generalized Estimating Equations model
0.494
Odds Ratio (OR)
1.473
2-Sided
95
0.49
4.47
Superiority or Other
OG000
OG003
Generalized Estimating Equations model
0.115
Odds Ratio (OR)
2.391
2-Sided
95
0.81
7.06
Superiority or Other
OG000
OG004
Generalized Estimating Equations model
0.045
Odds Ratio (OR)
2.960
2-Sided
95
1.02
8.55
Superiority or Other
OG000
OG005
Generalized Estimating Equations model
0.221
Odds Ratio (OR)
2.506
2-Sided
95
0.58
10.90
Superiority or Other
OG002
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Units
Counts
Participants
OG00028
OG00113
OG00232
OG00331
OG00432
OG00510
Title
Denominators
Categories
Title
Measurements
OG000-2.88(-5.87 to 0.10)
OG001-1.81(-6.18 to 2.57)
OG002-3.81(-6.76 to -0.85)
OG003-5.63(-8.44 to -2.81)
OG004-6.62(-9.51 to -3.72)
OG005-3.87(-8.68 to 0.94)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.662
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
1.07
2-Sided
95
-3.78
5.93
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.621
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-0.93
2-Sided
95
-4.63
2.77
Superiority or Other
OG000
OG003
Mixed Models Analysis
0.150
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-2.75
2-Sided
95
-6.50
1.01
Superiority or Other
OG000
OG004
Mixed Models Analysis
0.048
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-3.74
2-Sided
95
-7.43
-0.04
Superiority or Other
OG000
OG005
Mixed Models Analysis
0.715
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-0.99
2-Sided
95
-6.32
4.35
Superiority or Other
OG002
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Units
Counts
Participants
OG00027
OG00111
OG00228
OG00328
OG00425
OG0057
Title
Denominators
Categories
Title
Measurements
OG000-0.26(-1.23 to 0.72)
OG0010.91(-0.58 to 2.41)
OG002-0.73(-1.74 to 0.27)
OG003-1.13(-2.08 to -0.17)
OG004-1.27(-2.32 to -0.22)
OG005-0.99(-2.77 to 0.79)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.158
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
1.17
2-Sided
95
-0.46
2.81
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.446
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-0.47
2-Sided
95
-1.71
0.76
Superiority or Other
OG000
OG003
Mixed Models Analysis
0.163
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-0.87
2-Sided
95
-2.10
0.36
Superiority or Other
OG000
OG004
Mixed Models Analysis
0.117
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-1.01
2-Sided
95
-2.27
0.25
Superiority or Other
OG000
OG005
Mixed Models Analysis
0.456
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-0.73
2-Sided
95
-2.67
1.20
Superiority or Other
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG002
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Units
Counts
Participants
OG00028
OG00113
OG00232
OG00331
OG00432
OG00510
Title
Denominators
Categories
Title
Measurements
OG000-2.74(-5.79 to 0.31)
OG001-2.18(-6.65 to 2.29)
OG002-3.83(-6.85 to -0.81)
OG003-5.93(-8.80 to -3.06)
OG004-6.68(-9.64 to -3.71)
OG005-3.40(-8.30 to 1.50)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.823
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
0.56
2-Sided
95
-4.38
5.50
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.568
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-1.09
2-Sided
95
-4.86
2.68
Superiority or Other
OG000
OG003
Mixed Models Analysis
0.101
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-3.19
2-Sided
95
-7.01
0.63
Superiority or Other
OG000
OG004
Mixed Models Analysis
0.040
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-3.94
2-Sided
95
-7.70
-0.18
Superiority or Other
OG000
OG005
Mixed Models Analysis
0.811
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-0.66
2-Sided
95
-6.08
4.77
Superiority or Other
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG002
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Units
Counts
Participants
OG00033
OG00113
OG00234
OG00333
OG00434
OG00510
Title
Denominators
Categories
Title
Measurements
OG0000.05(-0.24 to 0.34)
OG001-0.34(-0.78 to 0.10)
OG002-0.01(-0.31 to 0.28)
OG003-0.26(-0.54 to 0.02)
OG004-0.02(-0.31 to 0.27)
OG0050.50(0.02 to 0.98)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.102
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-0.39
2-Sided
95
-0.86
0.08
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.723
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-0.06
2-Sided
95
-0.41
0.29
Superiority or Other
OG000
OG003
Mixed Models Analysis
0.084
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-0.31
2-Sided
95
-0.66
0.04
Superiority or Other
OG000
OG004
Mixed Models Analysis
0.697
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
-0.07
2-Sided
95
-0.42
0.28
Superiority or Other
OG000
OG005
Mixed Models Analysis
0.086
P-values are from a Mixed Model Repeated Measures analysis.
Mean Difference (Final Values)
0.45
2-Sided
95
-0.06
0.97
Superiority or Other
OG002
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
Units
Counts
Participants
OG00040
OG00113
OG00240
OG00340
OG00439
OG00513
Title
Denominators
Categories
Title
Measurements
OG00020
OG00115
OG00228
OG00345
OG00456
OG00523
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Generalized Estimating Equations model
0.733
Odds Ratio (OR)
0.769
2-Sided
95
0.17
3.49
Superiority or Other
OG000
OG002
Generalized Estimating Equations model
0.519
Odds Ratio (OR)
1.411
2-Sided
95
0.50
4.02
Superiority or Other
OG000
OG003
Generalized Estimating Equations model
0.008
Odds Ratio (OR)
4.204
2-Sided
95
1.46
12.07
Superiority or Other
OG000
OG004
Generalized Estimating Equations model
0.001
Odds Ratio (OR)
5.456
2-Sided
95
1.93
15.46
Superiority or Other
OG000
OG005
Generalized Estimating Equations model
0.752
Odds Ratio (OR)
1.281
2-Sided
95
0.27
5.98
Superiority or Other
OG003
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG004
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
OG005
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.