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Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome (ENCORE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01455012
First received: October 10, 2011
Last updated: July 19, 2013
Last verified: July 2013
Results First Received: May 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Restless Legs Syndrome
Interventions: Drug: Rotigotine
Drug: Placebo

  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
This study started to enroll subjects in September 2011 in order to end up with 9 German centers with enrolled subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant Flow refers to the Randomized Set (RS). RS consists of all subjects randomized into this study.

Reporting Groups
  Description
Placebo

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.


Participant Flow:   Overall Study
    Placebo     Rotigotine  
STARTED     41     40  
COMPLETED     30     36  
NOT COMPLETED     11     4  
Adverse Event                 0                 2  
Lack of Efficacy                 6                 1  
Withdrawal by Subject                 3                 1  
Unknown reason                 2                 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.
Baseline Characteristics refer to the Full Analysis Set (FAS). FAS includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable.

Reporting Groups
  Description
Placebo

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Total Total of all reporting groups

Baseline Measures
    Placebo     Rotigotine     Total  
Number of Participants  
[units: participants]
  29     37     66  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     23     26     49  
>=65 years     6     11     17  
Age  
[units: years]
Mean ± Standard Deviation
  56.0  ± 9.6     57.9  ± 10.2     57.0  ± 9.9  
Gender  
[units: participants]
     
Female     18     22     40  
Male     11     15     26  
Region of Enrollment  
[units: participants]
     
Germany     29     37     66  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the Number of Elevations of Systolic Blood Pressure (BP) During the Night That Are Associated With Periodic Limb Movements (PLMs) at the End of the 4-week Maintenance Period   [ Time Frame: Baseline to the end of the 4-week Maintenance Period ]

2.  Secondary:   Change From Baseline in the Total Number of Elevations of Systolic Blood Pressure (BP) During the Night at the End of the 4-week Maintenance Period   [ Time Frame: Baseline to the end of the 4-week Maintenance Period ]

3.  Secondary:   Change From Baseline in the Periodic Limb Movements Index (PLMI) at the End of the 4-week Maintenance Period   [ Time Frame: Baseline to the end of the 4-week Maintenance Period ]

4.  Secondary:   Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at the End of the 4-week Maintenance Period   [ Time Frame: Baseline to the end of the 4-week Maintenance Period ]

5.  Secondary:   Change From Baseline in Restless Legs Syndrome-Quality of Life (RLS-QoL) at the End of the 4-week Maintenance Period   [ Time Frame: Baseline to the end of the 4-week Maintenance Period ]

6.  Secondary:   Clinical Global Impressions (CGI) Item 2 (Change of Condition) at the End of the 4-week Maintenance Period   [ Time Frame: At the end of the 4-week Maintenance Period ]

7.  Secondary:   Clinical Global Impressions (CGI) Item 1 (Severity of Illness) at the End of the 4-week Maintenance Period   [ Time Frame: At the end of the 4-week Maintenance Period ]

8.  Secondary:   Clinical Global Impressions (CGI) Item 3 (Therapeutic Efficacy) at the End of the 4-week Maintenance Period   [ Time Frame: At the end of the 4-week Maintenance Period ]

9.  Secondary:   Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 1 at the End of the 4-week Maintenance Period   [ Time Frame: Baseline to the end of the 4-week Maintenance Period ]

10.  Secondary:   Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 2 at the End of the 4-week Maintenance Period   [ Time Frame: Baseline to the end of the 4-week Maintenance Period ]

11.  Secondary:   Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 3 at the End of the 4-week Maintenance Period   [ Time Frame: Baseline to the end of the 4-week Maintenance Period ]

12.  Secondary:   Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 4 at the End of the 4-week Maintenance Period   [ Time Frame: Baseline to the end of the 4-week Maintenance Period ]

13.  Secondary:   Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 5 at the End of the 4-week Maintenance Period   [ Time Frame: Baseline to the end of the 4-week Maintenance Period ]

14.  Secondary:   Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 6 at the End of the 4-week Maintenance Period   [ Time Frame: Baseline to the end of the 4-week Maintenance Period ]


  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
No text entered.


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493 (UCB)


No publications provided


Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01455012     History of Changes
Other Study ID Numbers: SP0977, 2011-000053-23
Study First Received: October 10, 2011
Results First Received: May 14, 2013
Last Updated: July 19, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices