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Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise (RLS-Practise)

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ClinicalTrials.gov Identifier: NCT01113710
Recruitment Status : Completed
First Posted : April 30, 2010
Results First Posted : September 28, 2012
Last Update Posted : September 28, 2012
Sponsor:
Information provided by (Responsible Party):

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Idiopathic Restless Legs Syndrome
Intervention: Drug: Neupro®

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

This study started in May 2010 with subjects from Germany. The study completed in July 2011. The Full Analysis Set is used for study outcome measures.

The Enrolled Set is reflected in the Participant Flow and Study Demographics. Age demographic information is missing for 1 subject and gender information is missing for 5 subjects.


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

The Participant Flow contains single and multiple reasons for "Other" subject discontinuation. Therefore, individual "Other" reasons are listed below:

Augmentation: 7

Problems with adhesiveness of patch: 6

Pruritus: 1

Tiredness: 1

Less effective than previous medication: 1

Application site reactions: 2

Neurotic: 1


Reporting Groups
  Description
Neupro® Routine treatment in accordance with the local marketing authorization for Neupro® in RLS

Participant Flow:   Overall Study
    Neupro®
STARTED   687 [1] 
COMPLETED   418 [2] 
NOT COMPLETED   269 
Adverse Event                64 
Lack of Efficacy                41 
No Information Available                40 
Withdrawal by Subject                28 
Lost to Follow-up                20 
Lack of Efficacy/Withdrawal by Subject                13 
Withdrawal by Subject/Adverse Event                11 
Lack of Patient's Compliance                8 
Other                7 
Adverse Event/Other                5 
Patient's Compliance/Lost to Follow up                5 
Lack of Efficacy/Other                4 
Patient Compliance/Withdrawal by Subject                4 
Lack of Efficacy/Adverse Event                3 
Efficacy/Subject Withdrawal/AE                2 
Compliance/Lost to Follow up/Pt Withdraw                2 
Lost to Follow up/Withdrawal by Subject                2 
Efficacy/Withdrawal by Subject/Other                1 
Compliance/Efficacy/Adverse Event                1 
Compliance/Efficacy/AE/Other                1 
Compliance/Efficacy/Subject Withdrawal                1 
Compliance/Lost to Follow up/Efficacy/AE                1 
Lack of Patient's Compliance/Other                1 
Compliance/Subject Withdrawal/AE                1 
Subject Did Not Receive Neupro                3 
[1] See Additional Study Description for further information regarding withdrawal due to Adverse Event.
[2] Discontinued reasons for "Other" are listed in the Participant Flow.



  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
Neupro® Routine treatment in accordance with the local marketing authorization for Neupro® in RLS

Baseline Measures
   Neupro® 
Overall Participants Analyzed 
[Units: Participants]
 687 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.6  (12.6) 
Age, Customized 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   278 
>=65 years   408 
Missing   1 
Gender, Customized 
[Units: Participants]
 
Female   494 
Male   188 
Missing   5 
Region of Enrollment 
[Units: Participants]
 
Germany   687 


  Outcome Measures

1.  Primary:   Severity of Restless Legs Syndrome (RLS) at Bedtime   [ Time Frame: From Baseline to end of Observation Period (3 months). ]

2.  Primary:   Severity of Restless Legs Syndrome (RLS) During the Night   [ Time Frame: From Baseline to end of Observation Period (3 months). ]

3.  Secondary:   Satisfaction With Sleep   [ Time Frame: From Baseline to end of Observation Period (3 months). ]

4.  Secondary:   Severity of Restless Legs Syndrome (RLS) at Daytime at Rest   [ Time Frame: From Baseline to end of Observation Period (3 months). ]

5.  Secondary:   Severity of Restless Legs Syndrome (RLS) at Daytime in Activity   [ Time Frame: From Baseline to end of Observation Period (3 months). ]

6.  Secondary:   Daytime Tiredness   [ Time Frame: From Baseline to end of Observation Period (3 months). ]


  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: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
phone: +1 887 822 9493


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

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01113710     History of Changes
Other Study ID Numbers: SP0948
First Submitted: April 28, 2010
First Posted: April 30, 2010
Results First Submitted: July 6, 2012
Results First Posted: September 28, 2012
Last Update Posted: September 28, 2012