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REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study

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ClinicalTrials.gov Identifier: NCT00485069
Recruitment Status : Completed
First Posted : June 12, 2007
Results First Posted : December 15, 2010
Last Update Posted : December 15, 2010
Sponsor:
Information provided by:
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Parkinson Disease
Parkinson's Disease
Interventions Drug: ROP
Drug: ROP+L-Dopa
Enrollment 123
Recruitment Details  
Pre-assignment Details 52 weeks of Treatment Phase, consisting of 4 weeks of Fixed Titration Phase and 48 weeks of Flexible Titration and Maintenance Phase, was started after 1 to 4 weeks of Screening Phase. Although the results are presented by participants with and without L-dopa, this study was a single-arm design, and L-dopa was not the investigational product.
Arm/Group Title ROP+L-Dopa Ropinirole Hydrochloride
Hide Arm/Group Description Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study. Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Period Title: Overall Study
Started 65 58
Completed 47 46
Not Completed 18 12
Reason Not Completed
Adverse Event             10             4
Lack of Efficacy             2             1
Protocol Violation             0             1
Withdrawal by Subject             6             6
Arm/Group Title ROP+L-Dopa Ropinirole Hydrochloride Total
Hide Arm/Group Description Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study. Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study. Total of all reporting groups
Overall Number of Baseline Participants 65 58 123
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 58 participants 123 participants
66.0  (7.94) 65.5  (7.18) 65.8  (7.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 58 participants 123 participants
Female
27
  41.5%
31
  53.4%
58
  47.2%
Male
38
  58.5%
27
  46.6%
65
  52.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 58 participants 123 participants
Asian - Japanese Heritage 65 58 123
Other 0 0 0
1.Primary Outcome
Title Mean Change From Baseline in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and Final Assessment Point (FAP)
Hide Description The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. Participants with "off" state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with "off" state at Week 52 and those prematurely withdrawn were not included at Week 52.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants enrolled in the Treatment Phase, excluding those with objective measurements not meeting the major eligibility criteria, who did not receive ROP at all, and those with no valid post-baseline data. Last observation carried forward (LOCF) was used for the FAP data to impute post-baseline missing values.
Arm/Group Title ROP+L-Dopa Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 65 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 52, n=45, 46 -7.0  (8.17) -6.9  (7.56)
FAP, n=61, 58 -5.8  (8.33) -5.5  (8.08)
2.Secondary Outcome
Title Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.
Arm/Group Title ROP+L-Dopa Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 65 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 52, n=47, 46 -0.4  (1.11) -0.1  (0.90)
FAP, n=64, 58 -0.2  (1.26) -0.0  (0.96)
3.Secondary Outcome
Title Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. "Off" state is where PD symptoms are not adequately controlled by the drug.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having no post-baseline data in "on" state, not having "off" state at baseline, or no data in "off" state at Week 52/withdrawal. These participants as well as those prematurely withdrawn were not included at Week 52.
Arm/Group Title ROP+L-Dopa, "On" State ROP+L-Dopa, "Off" State (Only Participants With "Off" State)
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Overall Number of Participants Analyzed 65 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 52, n=47, 13 -3.5  (4.19) -2.8  (3.77)
FAP, n=64, 22 -2.3  (4.54) -0.3  (6.46)
4.Secondary Outcome
Title Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.
Arm/Group Title Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 52, n=46 -2.2  (3.60)
FAP, n=58 -1.8  (3.86)
5.Secondary Outcome
Title Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.
Arm/Group Title ROP+L-Dopa Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 65 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 52, n=47, 46 0.1  (1.54) 0.3  (1.24)
FAP, n=64, 58 0.3  (1.75) 0.3  (1.15)
6.Secondary Outcome
Title Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.
Arm/Group Title ROP+L-Dopa Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 65 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline, n=65, 58 0.8  (1.35) 0.8  (1.10)
Week 52, n=47, 46 0.4  (0.77) 0.7  (1.11)
FAP, n=64, 58 0.7  (1.30) 0.8  (1.15)
7.Secondary Outcome
Title Mean Percent Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change, or having no post-baseline data. These participants as well as those prematurely withdrawn in each group were not included at Week 52.
Arm/Group Title ROP+L-Dopa Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 65 58
Mean (Standard Deviation)
Unit of Measure: percent change in score
Week 52, n=19, 22 -68.86  (41.929) -22.73  (79.772)
FAP, n=27, 26 -38.09  (109.715) -21.92  (73.595)
8.Secondary Outcome
Title Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. "Off" state is where PD symptoms are not adequately controlled by the drug. LOCF was used for the FAP data. Some participants were not included at FAP as having no post-baseline data in "on" state or having no data in "off" state at Week 52/withdrawal.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants without "off" state at baseline were not included in the analysis of baseline "off" state data. Participants not included at FAP as well as those prematurely withdrawn from the study were not included at Week 52.
Arm/Group Title ROP+L-Dopa, "On" State ROP+L-Dopa, "Off" Sate (Only Participants With "Off" State)
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Overall Number of Participants Analyzed 65 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline, n=65, 27 7.9  (5.51) 14.3  (9.04)
Week 52, n=47, 16 4.1  (4.37) 11.4  (5.93)
FAP, n=64, 26 5.5  (6.18) 15.2  (10.98)
9.Secondary Outcome
Title Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP in ROP Group
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.
Arm/Group Title Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline, n=58 7.7  (4.59)
Week 52, n=46 5.4  (4.65)
FAP, n=58 5.9  (4.52)
10.Secondary Outcome
Title Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. "Off" state is where PD symptoms are not adequately controlled by the drug. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for FAP data. Some participants were not included at FAP as having a baseline value of zero, having no post-baseline data in "on" state, not having "off" state at baseline in "off" state, or having no data at Week 52/withdrawal in "off" state. These participants as well as those prematurely withdrawn were not included at Week 52.
Arm/Group Title ROP+L-Dopa, "On" State ROP+L-Dopa, "Off" State (Only Participants With "Off" State)
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Overall Number of Participants Analyzed 65 32
Mean (Standard Deviation)
Unit of Measure: percent change in score
Week 52, n=47, 13 -48.98  (45.862) -17.68  (31.381)
FAP, n=62, 22 -29.00  (73.391) -4.10  (36.155)
11.Secondary Outcome
Title Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change. These participants as well as those prematurely withdrawn were not included at Week 52
Arm/Group Title Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 58
Mean (Standard Deviation)
Unit of Measure: percent change in score
Week 52, n=44 -24.35  (59.429)
FAP, n=56 -16.74  (61.175)
12.Secondary Outcome
Title Japanese UPDRS Part III Mean Total Score (in "On" State for the ROP+L-Dopa Group) at Baseline, Week 52, and FAP
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants having "off" state at baseline were not included in the ROP+L-dopa group at baseline. The participant not included in the FAP as well as one having "off" state in the ROP+L-dopa group at Week 52 and those prematurely withdrawn in each group were not included at Week 52.
Arm/Group Title ROP+L-Dopa Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 65 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline, n=62,58 20.5  (12.44) 19.8  (12.10)
Week 52, n=46, 46 12.7  (10.26) 13.1  (10.86)
FAP, n=64, 58 14.3  (12.20) 14.3  (11.01)
13.Secondary Outcome
Title Mean Percent Change From Baseline in the Japanese UPDRS Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and FAP
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants with "off" state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with "off" state at Week 52 in that group and those prematurely withdrawn in each group were not included at Week 52.
Arm/Group Title ROP+L-Dopa Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 65 58
Mean (Standard Deviation)
Unit of Measure: percent change in score
Week 52, n=45, 46 -36.83  (40.001) -37.73  (34.739)
FAP, n=61, 58 -30.42  (41.427) -27.79  (42.531)
14.Secondary Outcome
Title Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.
Arm/Group Title ROP+L-Dopa Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 65 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline, n=65, 58 2.1  (3.01) 0.5  (1.17)
Week 52, n=47, 46 1.5  (1.77) 0.8  (1.33)
FAP, n=64, 58 2.4  (3.30) 0.8  (1.26)
15.Secondary Outcome
Title Mean Percent Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP
Hide Description The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change, or having no post-baseline data. These participants as well as those prematurely withdrawn from the study were not included at Week 52.
Arm/Group Title ROP+L-Dopa Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 65 58
Mean (Standard Deviation)
Unit of Measure: percent change in score
Week 52, n=23, 17 -8.70  (62.889) 0.00  (115.920)
FAP, n=37, 20 13.30  (91.068) -2.50  (109.394)
16.Secondary Outcome
Title Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group
Hide Description The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. LOCF was used for the FAP data to impute post-baseline missing values. Some participants in each state were not included at FAP as having no post-baseline data in the corresponding state or having no data in the corresponding state at Week 52/withdrawal.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants without "off" state at baseline were not included in the analysis of baseline "off" state data. Participants not included at FAP as well as those prematurely withdrawn from the study were not included at Week 52.
Arm/Group Title ROP+L-Dopa, "On" State ROP+L-Dopa, "Off" State (Only Participants With "Off" State)
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Overall Number of Participants Analyzed 65 32
Measure Type: Number
Unit of Measure: participants
Baseline, n=65, 27, Stage 0 0 0
Baseline, n=65, 27, Stage 1 5 0
Baseline, n=65, 27, Stage 1.5 3 1
Baseline, n=65, 27, Stage 2 22 2
Baseline, n=65, 27, Stage 2.5 16 9
Baseline, n=65, 27, Stage 3 16 7
Baseline, n=65, 27, Stage 4 3 6
Baseline, n=65, 27, Stage 5 0 2
Week 52, n=47, 16, Stage 0 1 0
Week 52, n=47, 16, Stage 1 10 1
Week 52, n=47, 16, Stage 1.5 6 1
Week 52, n=47, 16, Stage 2 15 1
Week 52, n=47, 16, Stage 2.5 6 4
Week 52, n=47, 16, Stage 3 8 4
Week 52, n=47, 16, Stage 4 1 4
Week 52, n=47, 16, Stage 5 0 1
FAP, n=63, 25, Stage 0 1 0
FAP, n=63, 25, Stage 1 13 1
FAP, n=63, 25, Stage 1.5 7 1
FAP, n=63, 25, Stage 2 21 1
FAP, n=63, 25, Stage 2.5 7 5
FAP, n=63, 25, Stage 3 11 7
FAP, n=63, 25, Stage 4 3 7
FAP, n=63, 25, Stage 5 0 3
17.Secondary Outcome
Title Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group
Hide Description The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided.
Time Frame Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.
Arm/Group Title Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: participants
Baseline, n=58, Stage 0 0
Baseline, n=58, Stage 1 9
Baseline, n=58, Stage 1.5 2
Baseline, n=58, Stage 2 21
Baseline, n=58, Stage 2.5 14
Baseline, n=58, Stage 3 12
Baseline, n=58, Stage 4 0
Baseline, n=58, Stage 5 0
Week 52, n=46, Stage 0 1
Week 52, n=46, Stage 1 12
Week 52, n=46, Stage 1.5 1
Week 52, n=46, Stage 2 14
Week 52, n=46, Stage 2.5 13
Week 52, n=46, Stage 3 5
Week 52, n=46, Stage 4 0
Week 52, n=46, Stage 5 0
FAP, n=58, Stage 0 1
FAP, n=58, Stage 1 13
FAP, n=58, Stage 1.5 2
FAP, n=58, Stage 2 17
FAP, n=58, Stage 2.5 18
FAP, n=58, Stage 3 7
FAP, n=58, Stage 4 0
FAP, n=58, Stage 5 0
18.Secondary Outcome
Title Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group
Hide Description The Schwab and England Activities of Daily Living Scale Score is measured as percentage, from 100% (Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal. Unaware of any difficulty) to 0% (Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden).
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data. Some participants were not included at FAP as having no post-baseline data in "on" state, not having "off" state at baseline in "off" state, or having no data in the corresponding state at Week 52/withdrawal. These participants as well as those prematurely withdrawn were not included at Week 52.
Arm/Group Title ROP+L-Dopa, "On" State ROP+L-Dopa, "Off" State (Only Participants With "Off" State)
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Overall Number of Participants Analyzed 65 32
Mean (Standard Deviation)
Unit of Measure: percent change
Week 52, n=47, 13 3.4  (10.52) 5.8  (16.31)
FAP, n=63, 21 3.0  (9.97) 2.6  (14.63)
19.Secondary Outcome
Title Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP in ROP Group
Hide Description The Schwab and England Activities of Daily Living Scale Score is measured as percentage, from 100% (Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal. Unaware of any difficulty) to 0% (Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden).
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.
Arm/Group Title Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 58
Mean (Standard Deviation)
Unit of Measure: percent change
Week 52, n=46 2.1  (6.74)
FAP, n=58 1.5  (7.28)
20.Secondary Outcome
Title Percentage of Participants Remaining in the Study on the Indicated Days in the ROP+L-Dopa Group
Hide Description The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 52) was the event, and participants who had completed the study were censored.
Time Frame Days 0-422
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title ROP+L-Dopa
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: percentage of participants
Day 0 100
Day 22 98
Day 33 95
Day 43 94
Day 85 92
Day 101 91
Day 112 89
Day 128 88
Day 154 86
Day 169 83
Day 196 82
Day 203 80
Day 238 78
Day 282 77
Day 301 75
Day 341 74
Day 365 72
Day 422 72
21.Secondary Outcome
Title Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group
Hide Description The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 52) was the event, and participants who had completed the study were censored.
Time Frame Days 0-419
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: percentage of participants
Day 0 100
Day 14 98
Day 29 97
Day 36 95
Day 66 93
Day 71 91
Day 85 90
Day 167 88
Day 169 86
Day 175 84
Day 210 83
Day 241 81
Day 253 79
Day 419 79
22.Secondary Outcome
Title Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP
Hide Description CGI is measured on the following 7-point scale: 1, Very much improved; 2, Much Improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; and 7, Very much worse. Responders are defined as those participants scored as "very much improved" or "much improved."
Time Frame Week 52 and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.
Arm/Group Title ROP+L-Dopa Ropinirole Hydrochloride
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Overall Number of Participants Analyzed 65 58
Measure Type: Number
Unit of Measure: participants
Week 52, n=47, 46 33 28
FAP, n=64, 58 34 31
23.Secondary Outcome
Title Mean Change From Baseline in Awake Time "Off" (Hours) and Awake Time "On" (Hours) at Week 52 and FAP in the ROP+L-Dopa Group Excluding Participants With "0" Off (Hour) at Baseline
Hide Description "Off" state is where PD symptoms are not adequately controlled by the drug. "On" state is where PD symptoms are well controlled by the drug. The "off’s" duration (awake time spent "off") and the "on’s" duration (awake time spent "on") on each day were calculated.
Time Frame Baseline, Week 52, and FAP (up to Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants having "off" hour of zero at baseline were not included at FAP. These participants as well as those prematurely withdrawn from the study were not included at Week 52.
Arm/Group Title ROP+L-Dopa, "Off" Hours ROP+L-Dopa, "On" Hours
Hide Arm/Group Description:
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Overall Number of Participants Analyzed 65 65
Mean (Standard Deviation)
Unit of Measure: hours
Week 52, n=16 -0.09  (3.502) 1.00  (4.090)
FAP, n=22 -0.40  (3.453) 1.00  (3.867)
Time Frame From Baseline (Week 0) through the end of follow-up (up to Week 56).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ROP+L-Dopa Ropinirole Hydrochloride
Hide Arm/Group Description Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study. Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
All-Cause Mortality
ROP+L-Dopa Ropinirole Hydrochloride
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ROP+L-Dopa Ropinirole Hydrochloride
Affected / at Risk (%) Affected / at Risk (%)
Total   7/65 (10.77%)   3/58 (5.17%) 
Ear and labyrinth disorders     
Vertigo  1  1/65 (1.54%)  0/58 (0.00%) 
Eye disorders     
Cataract  1  0/65 (0.00%)  1/58 (1.72%) 
Infections and infestations     
Pyelonephritis  1  1/65 (1.54%)  0/58 (0.00%) 
Injury, poisoning and procedural complications     
Meniscus lesion  1  1/65 (1.54%)  0/58 (0.00%) 
Spinal compression fracture  1  1/65 (1.54%)  0/58 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/65 (0.00%)  1/58 (1.72%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/65 (1.54%)  0/58 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer recurrent  1  0/65 (0.00%)  1/58 (1.72%) 
Nervous system disorders     
Parkinson’s Disease  1  1/65 (1.54%)  0/58 (0.00%) 
Sudden onset of sleep  1  1/65 (1.54%)  0/58 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ROP+L-Dopa Ropinirole Hydrochloride
Affected / at Risk (%) Affected / at Risk (%)
Total   42/65 (64.62%)   43/58 (74.14%) 
Gastrointestinal disorders     
Nausea  1  7/65 (10.77%)  4/58 (6.90%) 
Constipation  1  7/65 (10.77%)  2/58 (3.45%) 
Dental caries  1  2/65 (3.08%)  3/58 (5.17%) 
Stomatitis  1  1/65 (1.54%)  3/58 (5.17%) 
Gastritis  1  0/65 (0.00%)  3/58 (5.17%) 
Infections and infestations     
Nasopharyngitis  1  13/65 (20.00%)  19/58 (32.76%) 
Injury, poisoning and procedural complications     
Contusion  1  4/65 (6.15%)  3/58 (5.17%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/65 (1.54%)  3/58 (5.17%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  4/65 (6.15%)  4/58 (6.90%) 
Arthralgia  1  1/65 (1.54%)  3/58 (5.17%) 
Nervous system disorders     
Somnolence  1  16/65 (24.62%)  14/58 (24.14%) 
Headache  1  4/65 (6.15%)  3/58 (5.17%) 
Parkinson’s Disease  1  7/65 (10.77%)  0/58 (0.00%) 
Sudden onset of sleep  1  3/65 (4.62%)  3/58 (5.17%) 
Dizziness  1  0/65 (0.00%)  4/58 (6.90%) 
Dyskinesia  1  4/65 (6.15%)  0/58 (0.00%) 
Tremor  1  0/65 (0.00%)  3/58 (5.17%) 
Psychiatric disorders     
Hallucination  1  4/65 (6.15%)  5/58 (8.62%) 
Vascular disorders     
Orthostatic hypotension  1  3/65 (4.62%)  5/58 (8.62%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00485069     History of Changes
Other Study ID Numbers: 108862
First Submitted: June 11, 2007
First Posted: June 12, 2007
Results First Submitted: September 20, 2010
Results First Posted: December 15, 2010
Last Update Posted: December 15, 2010