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Trial record 1 of 1 for:    NCT01495793
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Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome

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ClinicalTrials.gov Identifier: NCT01495793
Recruitment Status : Completed
First Posted : December 20, 2011
Results First Posted : July 14, 2015
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Restless Legs Syndrome
Intervention Drug: Rotigotine
Enrollment 42
Recruitment Details This was a multicenter study in which 42 subjects were enrolled and 24 treated at 8 sites in the USA.
Pre-assignment Details 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).
Arm/Group Title Rotigotine
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 24
Completed 22
Not Completed 2
Reason Not Completed
Lost to Follow-up             1
Violation of inclusion criteria             1
Arm/Group Title Rotigotine
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
Baseline Characteristics refers to the 24 treated subjects (Safety Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
15.3  (1.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants
13 years 2
14 years 6
15 years 6
16 years 4
17 years 6
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
15
  62.5%
Male
9
  37.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino
4
  16.7%
Not Hispanic or Latino
20
  83.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
  33.3%
White
16
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 24 participants
167.39  (6.89)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 24 participants
65.70  (10.72)
BMI (Body Mass Index)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 24 participants
23.388  (3.133)
1.Primary Outcome
Title Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 0.5 mg/24 h (2.5 cm^2)
Hide Description

CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.

For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation.

Time Frame 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.
Arm/Group Title Rotigotine (PKPPS)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 6
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L/h (liter per hour)
676.86
(408.50 to 1121.51)
2.Primary Outcome
Title Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 1 mg/24 h (5 cm^2)
Hide Description

CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.

For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation.

Time Frame 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.
Arm/Group Title Rotigotine (PKPPS)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 10
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L/h (Liter per hour)
671.72
(459.11 to 982.80)
3.Primary Outcome
Title Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 2 mg/24 h (10 cm^2)
Hide Description

CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.

For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation.

Time Frame 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.
Arm/Group Title Rotigotine (PKPPS)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L/h (Liter per hour)
937.56
(658.50 to 1334.89)
4.Primary Outcome
Title Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 3 mg/24 h (15 cm^2)
Hide Description

CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.

For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation.

Time Frame 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.
Arm/Group Title Rotigotine (PKPPS)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 9
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L/h (Liter per hour)
1088.77
(723.47 to 1638.53)
5.Primary Outcome
Title Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 0.5 mg/24 h (2.5 cm^2)
Hide Description

VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.

For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation.

Time Frame 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.
Arm/Group Title Rotigotine (PKPPS)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 6
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L (Liter)
5403.16
(2850.67 to 10241.17)
6.Primary Outcome
Title Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 1 mg/24 h (5 cm^2)
Hide Description

VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.

For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation.

Time Frame 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.
Arm/Group Title Rotigotine (PKPPS)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 10
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L (Liter)
6220.79
(3842.05 to 10072.28)
7.Primary Outcome
Title Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 2 mg/24 h (10 cm^2)
Hide Description

VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.

For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation.

Time Frame 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.
Arm/Group Title Rotigotine (PKPPS)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L (Liter)
7114.01
(4547.88 to 11128.07)
8.Primary Outcome
Title Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 3 mg/24 h (15 cm^2)
Hide Description

VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.

For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation.

Time Frame 0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.
Arm/Group Title Rotigotine (PKPPS)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 9
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L (Liter)
6037.92
(3598.36 to 10131.41)
Time Frame This summary includes TEAEs from the Titration period, Taper period and Safety Follow-up (Day 1 up to 69 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rotigotine
Hide Arm/Group Description 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.
All-Cause Mortality
Rotigotine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Rotigotine
Affected / at Risk (%) # Events
Total   0/24 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rotigotine
Affected / at Risk (%) # Events
Total   15/24 (62.50%)    
Gastrointestinal disorders   
Diarrhoea * 1  1/24 (4.17%)  1
Nausea * 1  7/24 (29.17%)  11
Vomiting * 1  2/24 (8.33%)  2
General disorders   
Application site pruritus * 1  4/24 (16.67%)  4
Application site irritation * 1  1/24 (4.17%)  1
Irritability * 1  1/24 (4.17%)  1
Immune system disorders   
Allergy to arthropod sting * 1  1/24 (4.17%)  1
Food allergy * 1  1/24 (4.17%)  1
Infections and infestations   
Cellulitis * 1  1/24 (4.17%)  1
Fungal infection * 1  1/24 (4.17%)  1
Influenza * 1  1/24 (4.17%)  1
Nasopharyngitis * 1  2/24 (8.33%)  3
Pharyngitis * 1  1/24 (4.17%)  1
Upper respiratory tract infection * 1  1/24 (4.17%)  1
Injury, poisoning and procedural complications   
Stress fracture * 1  1/24 (4.17%)  1
Animal bite * 1  1/24 (4.17%)  1
Road traffic accident * 1  1/24 (4.17%)  1
Wound * 1  1/24 (4.17%)  1
Investigations   
Blood bilirubin increased * 1  2/24 (8.33%)  2
Metabolism and nutrition disorders   
Anorexia * 1  1/24 (4.17%)  1
Increased appetite * 1  1/24 (4.17%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/24 (4.17%)  1
Muscular weakness * 1  1/24 (4.17%)  1
Musculoskeletal chest pain * 1  1/24 (4.17%)  1
Muscukoseletal pain * 1  1/24 (4.17%)  1
Neck pain * 1  1/24 (4.17%)  1
Pain in extremity * 1  1/24 (4.17%)  1
Nervous system disorders   
Somnolence * 1  1/24 (4.17%)  1
Syncope * 1  1/24 (4.17%)  1
Headache * 1  2/24 (8.33%)  2
Migraine * 1  1/24 (4.17%)  1
Dizzines * 1  2/24 (8.33%)  2
Sudden onset of sleep * 1  1/24 (4.17%)  2
Reproductive system and breast disorders   
Dysmenorrhoea * 1  1/24 (4.17%)  1
Skin and subcutaneous tissue disorders   
Acne * 1  1/24 (4.17%)  1
Urticaria * 1  1/24 (4.17%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA9.1
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
Phone: +1877-822 ext 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT01495793    
Other Study ID Numbers: SP1004
2014-004383-37 ( EudraCT Number )
First Submitted: December 16, 2011
First Posted: December 20, 2011
Results First Submitted: April 29, 2015
Results First Posted: July 14, 2015
Last Update Posted: April 4, 2018