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Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01536574
First Posted: February 22, 2012
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: November 15, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Parkinson Disease
Intervention: Drug: Requip PR

  Participant Flow
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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
Participants who completed 24 weeks of randomized treatment in parent Study ROP111528 (NCT01154166) and 1 week of down titration at the end of treatment or at early withdraw were allowed to enter this extension study provided they had continued on study drug without a break.

Reporting Groups
  Description
Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
Placebo in Parent DB Study, Ropinirole PR in OL Study Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.

Participant Flow:   Overall Study
    Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study   Placebo in Parent DB Study, Ropinirole PR in OL Study
STARTED   162   133 
COMPLETED   156   126 
NOT COMPLETED   6   7 
Adverse Event                4                5 
Withdrawal by Subject                1                2 
Lack of Efficacy                1                0 



  Baseline Characteristics
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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
Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
Placebo in Parent DB Study, Ropinirole PR in OL Study Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
Total Total of all reporting groups

Baseline Measures
   Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study   Placebo in Parent DB Study, Ropinirole PR in OL Study   Total 
Overall Participants Analyzed 
[Units: Participants]
 162   133   295 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.5  (9.10)   63.9  (9.87)   64.2  (9.44) 
Gender 
[Units: Participants]
Count of Participants
     
Female      51  31.5%      53  39.8%      104  35.3% 
Male      111  68.5%      80  60.2%      191  64.7% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Oriental   162   133   295 
Duration of Parkinson's Disease 
[Units: Months]
Mean (Standard Deviation)
 96.8  (59.68)   105.3  (49.61)   100.7  (55.44) 


  Outcome Measures
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1.  Primary:   Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase)   [ Time Frame: From the start of treatment (Baseline) up to Week 25 ]

2.  Primary:   Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase   [ Time Frame: From the start of treatment (Baseline) up to Week 25 ]

3.  Primary:   Number of Participants With an Adverse Event During the Follow-up Phase   [ Time Frame: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) ]

4.  Primary:   Number of Participants With the Indicated Adverse Events During the Follow-up Phase   [ Time Frame: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) ]

5.  Primary:   Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase   [ Time Frame: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) ]

6.  Secondary:   Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24   [ Time Frame: Week 24 ]

7.  Secondary:   Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24   [ Time Frame: Baseline and Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01536574     History of Changes
Other Study ID Numbers: 114463
First Submitted: January 19, 2012
First Posted: February 22, 2012
Results First Submitted: November 15, 2012
Results First Posted: December 13, 2012
Last Update Posted: February 28, 2017