Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier:
NCT01495793
First received: December 16, 2011
Last updated: June 17, 2015
Last verified: June 2015
Results First Received: April 29, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Restless Legs Syndrome
Intervention: Drug: Rotigotine

  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 was a multicenter study in which 42 subjects were enrolled and 24 treated at 8 sites in the USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total 42 subjects signed the informed consent and were enrolled into the study (Enrolled Set). 24 of these subjects were treated with medication. The sample size of 24 subjects was sufficient to target a 95% confidence interval and the calculation was based on a previous study. Participant Flow refers to the 24 treated subjects (Safety Set).

Reporting Groups
  Description
Rotigotine In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.

Participant Flow:   Overall Study
    Rotigotine  
STARTED     24  
COMPLETED     22  
NOT COMPLETED     2  
Lost to Follow-up                 1  
Violation of inclusion criteria                 1  



  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 refers to the 24 treated subjects (Safety Set).

Reporting Groups
  Description
Rotigotine In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
Total Title No text entered.

Baseline Measures
    Rotigotine     Total Title  
Number of Participants  
[units: participants]
  24     24  
Age  
[units: years]
Mean (Standard Deviation)
  15.3  (1.3)      
Age, Customized  
[units: Participants]
   
13 years     2      
14 years     6      
15 years     6      
16 years     4      
17 years     6      
Gender  
[units: Participants]
   
Female     15      
Male     9      
Ethnicity (NIH/OMB)  
[units: Participants]
   
Hispanic or Latino     4      
Not Hispanic or Latino     20      
Unknown or Not Reported     0      
Race (NIH/OMB)  
[units: Participants]
   
American Indian or Alaska Native     0      
Asian     0      
Native Hawaiian or Other Pacific Islander     0      
Black or African American     8      
White     16      
More than one race     0      
Unknown or Not Reported     0      
Height  
[units: cm]
Mean (Standard Deviation)
  167.39  (6.89)      
Weight  
[units: kg]
Mean (Standard Deviation)
  65.70  (10.72)      
BMI (Body Mass Index)  
[units: kg/m^2]
Mean (Standard Deviation)
  23.388  (3.133)      



  Outcome Measures
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1.  Primary:   Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 0.5 mg/24 h (2.5 cm^2)   [ Time Frame: 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28 ]

2.  Primary:   Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 1 mg/24 h (5 cm^2)   [ Time Frame: 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28 ]

3.  Primary:   Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 2 mg/24 h (10 cm^2)   [ Time Frame: 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28 ]

4.  Primary:   Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 3 mg/24 h (15 cm^2)   [ Time Frame: 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28 ]

5.  Primary:   Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 0.5 mg/24 h (2.5 cm^2)   [ Time Frame: 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28 ]

6.  Primary:   Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 1 mg/24 h (5 cm^2)   [ Time Frame: 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28 ]

7.  Primary:   Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 2 mg/24 h (10 cm^2)   [ Time Frame: 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28 ]

8.  Primary:   Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 3 mg/24 h (15 cm^2)   [ Time Frame: 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28 ]


  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 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 Pharma
phone: +1877-822 ext 9493


No publications provided


Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT01495793     History of Changes
Other Study ID Numbers: SP1004, 2014-004383-37
Study First Received: December 16, 2011
Results First Received: April 29, 2015
Last Updated: June 17, 2015
Health Authority: United States: Food and Drug Administration