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

Phase 4

Completed

• Conditions: Parkinson Disease; Parkinson's Disease
• Interventions: Drug: ROP; Drug: ROP+L-Dopa

• Registration Number: NCT00485069
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease (PD) on 20 October 2006.

ROP is expected to be used for a long term in clinical practice. However, no long-term clinical data with ROP administered three times daily are currently available from Japanese patients, and the clinical experience with ROP at \>10mg/day is limited.

For this reason, this study was designed as a multicenter open-label uncontrolled study.

This study will evaluate the long-term efficacy (Japanese Unified Parkinson's Disease Rating Scale (UPDRS), Awake time spent "Off"/"On", Modified Hoehn \& Yahr stage, Schwab-England scale, Proportion of subjects remaining in this study and Clinical Global Impression (CGI)) and the long-term safety of ROP administered three times daily for in PD patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-11
• Study First Submitted QC: 2007-06-11
• Study First Posted: 2007-06-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Disposition First Submitted: 2010-08-12
• Disposition First Submitted QC: 2010-08-12
• Disposition First Posted: 2010-08-17
• Results First Submitted: 2010-09-20
• Status Verified: 2010-11
• Results First Submitted QC: 2010-11-18
• Last Update Submitted: 2010-11-18
• Results First Posted: 2010-12-15
• Last Update Posted: 2010-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ropinirole Hydrochloride	ROP	-
Ropinirole Hydrochloride	ROP+L-Dopa	-

Primary Outcome Measures

Name	Time	Method
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)	Baseline, Week 52, and FAP (up to Week 52)	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP	Baseline, Week 52, and FAP (up to Week 52)	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.
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	Baseline, Week 52, and FAP (up to Week 52)	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.
Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group	Baseline, Week 52, and FAP (up to Week 52)	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.
Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP	Baseline, Week 52, and FAP (up to Week 52)	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.
Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP	Baseline, Week 52, and FAP (up to Week 52)	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.
Mean Percent Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP	Baseline, Week 52, and FAP (up to Week 52)	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.
Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group	Baseline, Week 52, and FAP (up to Week 52)	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.
Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP in ROP Group	Baseline, Week 52, and FAP (up to Week 52)	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.
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	Baseline, Week 52, and FAP (up to Week 52)	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.
Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group	Baseline, Week 52, and FAP (up to Week 52)	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.
Japanese UPDRS Part III Mean Total Score (in "On" State for the ROP+L-Dopa Group) at Baseline, Week 52, and FAP	Baseline, Week 52, and FAP (up to Week 52)	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.
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	Baseline, Week 52, and FAP (up to Week 52)	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.
Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP	Baseline, Week 52, and FAP (up to Week 52)	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.
Mean Percent Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP	Baseline, Week 52, and FAP (up to Week 52)	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.
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	Baseline, Week 52, and FAP (up to Week 52)	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.
Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group	Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group	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.
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	Baseline, Week 52, and FAP (up to Week 52)	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).
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	Baseline, Week 52, and FAP (up to Week 52)	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).
Percentage of Participants Remaining in the Study on the Indicated Days in the ROP+L-Dopa Group	Days 0-422	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.
Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group	Days 0-419	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.
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP	Week 52 and FAP (up to Week 52)	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."
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	Baseline, Week 52, and FAP (up to Week 52)	"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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Tokyo, Japan