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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
ROP+L-Dopa 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.
Ropinirole Hydrochloride 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.

Participant Flow:   Overall Study
    ROP+L-Dopa   Ropinirole Hydrochloride
STARTED   65   58 
COMPLETED   47   46 
NOT COMPLETED   18   12 
Adverse Event                10                4 
Lack of Efficacy                2                1 
Protocol Violation                0                1 
Withdrawal by Subject                6                6 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ROP+L-Dopa 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.
Ropinirole Hydrochloride 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 Total of all reporting groups

Baseline Measures
   ROP+L-Dopa   Ropinirole Hydrochloride   Total 
Overall Participants Analyzed 
[Units: Participants]
 65   58   123 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.0  (7.94)   65.5  (7.18)   65.8  (7.56) 
Gender 
[Units: Participants]
     
Female   27   31   58 
Male   38   27   65 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian - Japanese Heritage   65   58   123 
Other   0   0   0 


  Outcome Measures

1.  Primary:   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)   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

2.  Secondary:   Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

3.  Secondary:   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   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

4.  Secondary:   Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

5.  Secondary:   Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

6.  Secondary:   Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

7.  Secondary:   Mean Percent Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

8.  Secondary:   Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

9.  Secondary:   Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP in ROP Group   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

10.  Secondary:   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   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

11.  Secondary:   Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

12.  Secondary:   Japanese UPDRS Part III Mean Total Score (in "On" State for the ROP+L-Dopa Group) at Baseline, Week 52, and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

13.  Secondary:   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   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

14.  Secondary:   Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

15.  Secondary:   Mean Percent Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

16.  Secondary:   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   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

17.  Secondary:   Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group   [ Time Frame: Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group ]

18.  Secondary:   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   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

19.  Secondary:   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   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

20.  Secondary:   Percentage of Participants Remaining in the Study on the Indicated Days in the ROP+L-Dopa Group   [ Time Frame: Days 0-422 ]

21.  Secondary:   Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group   [ Time Frame: Days 0-419 ]

22.  Secondary:   Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP   [ Time Frame: Week 52 and FAP (up to Week 52) ]

23.  Secondary:   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   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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