Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01170091
First received: July 26, 2010
Last updated: March 14, 2014
Last verified: March 2014
Results First Received: June 27, 2012  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Restless Legs Syndrome

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Mirapex Patients with RLS who had initiated with Mirapex

Participant Flow:   Overall Study
    Mirapex  
STARTED     651  
COMPLETED     627  
NOT COMPLETED     24  
Missing efficacy evaluation                 3  
Treatment duration is less than 4 weeks                 21  



  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.
Safety Analysis Set

Reporting Groups
  Description
Patients With Restless Legs Syndrome (RLS) Patients with RLS who had initiated with Mirapex

Baseline Measures
    Patients With Restless Legs Syndrome (RLS)  
Number of Participants  
[units: participants]
  651  
Age  
[units: Years]
Mean ± Standard Deviation
  60.9  ± 13.2  
Gender, Customized  
[units: Participants]
 
Female     369  
Male     276  
Not reported     6  



  Outcome Measures
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1.  Primary:   Number of Reported Adverse Events   [ Time Frame: Up to 4 weeks ]

2.  Secondary:   International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment   [ Time Frame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration) ]

3.  Secondary:   Patient-Global Impressions (PGI-I)   [ Time Frame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration) ]

4.  Secondary:   Clinical Global Impressions-Global Improvement (CGI-I)   [ Time Frame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration) ]


  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: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01170091     History of Changes
Other Study ID Numbers: 248.653
Study First Received: July 26, 2010
Results First Received: June 27, 2012
Last Updated: March 14, 2014
Health Authority: Korea, Republic of: Korea Food and Drug Administration (KFDA)