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Trial record 1 of 1 for:    sp1006
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A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728933
Recruitment Status : Terminated (Sponsor decision; Not a safety decision)
First Posted : November 2, 2018
Results First Posted : October 26, 2023
Last Update Posted : October 26, 2023
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Restless Legs Syndrome
Interventions Drug: Rotigotine 1 milligram/24 hours
Drug: Rotigotine 2 milligram/24 hours
Drug: Placebo
Enrollment 23
Recruitment Details The study started to enroll participants in December 2018 and concluded prematurely in July 2022.
Pre-assignment Details The Participant Flow refers to the Randomized Set.
Arm/Group Title Placebo Rotigotine 2 mg/24h Rotigotine 3 mg/24h
Hide Arm/Group Description Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period. Participants randomized to this arm were initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period. Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Period Title: Overall Study
Started 8 8 7
Completed 5 7 6
Not Completed 3 1 1
Reason Not Completed
Withdrawal by Parent/Guardian             2             0             0
Withdrawal by Subject             0             0             1
Lost to Follow-up             0             1             0
Adverse Event             1             0             0
Arm/Group Title Placebo Rotigotine 2 mg/24h Rotigotine 3 mg/24h Total
Hide Arm/Group Description Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period. Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period. Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period. Total of all reporting groups
Overall Number of Baseline Participants 8 8 7 23
Hide Baseline Analysis Population Description
The Randomized Set consisted of all participants from the Enrolled Set who have been randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 7 participants 23 participants
15.4  (1.3) 16.1  (1.1) 15.6  (1.0) 15.7  (1.1)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 7 participants 23 participants
Adolescents (12-17 years)
8
 100.0%
8
 100.0%
7
 100.0%
23
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 7 participants 23 participants
Female
6
  75.0%
6
  75.0%
2
  28.6%
14
  60.9%
Male
2
  25.0%
2
  25.0%
5
  71.4%
9
  39.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 7 participants 23 participants
American Indian/Alaskan Native
0
   0.0%
1
  12.5%
0
   0.0%
1
   4.3%
Black
0
   0.0%
0
   0.0%
1
  14.3%
1
   4.3%
White
7
  87.5%
7
  87.5%
6
  85.7%
20
  87.0%
Other/Mixed
1
  12.5%
0
   0.0%
0
   0.0%
1
   4.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 7 participants 23 participants
Not Hispanic or Latino
8
 100.0%
8
 100.0%
7
 100.0%
23
 100.0%
1.Primary Outcome
Title Change From Baseline to the End of the Maintenance Period in International Restless Legs Rating Scale (IRLS) Sum Score
Hide Description The IRLS consisted of 10 questions, each scored using a 5-point scale ranging from 0=not present to 4=very severe. The IRLS sum score was calculated by summing up the single scores of all applicable questions, i.e., the total sum score ranged from 0 (no RLS symptoms present) to 40 (maximum severity in all symptoms). A score between 31 and 40, indicates very severe RLS. A score between 21 and 30 indicates severe RLS. A score between 11 and 20 indicates moderate RLS. A score between 1 and 10 indicates mild RLS and a score of 0 means no RLS. A negative change from Baseline indicates improvement.
Time Frame From Baseline to the end of the Maintenance Period (Day 106)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all participants from the Safety Set who had a valid IRLS score and a valid clinical global impressions (CGI) Item 1 score at Baseline and a valid post-Baseline IRLS score and a valid post-Baseline CGI Item 1 score. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.
Arm/Group Title Placebo Rotigotine 2 mg/24h Rotigotine 3 mg/24h
Hide Arm/Group Description:
Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.
Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Overall Number of Participants Analyzed 5 7 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-8.2  (6.8) -14.0  (8.2) -6.4  (5.8)
2.Primary Outcome
Title Change From Baseline in Clinical Global Impressions (CGI) Item 1 to the End of the Maintenance Period
Hide Description The Clinical Global Impressions Item 1 (Severity of Illness) score ranges from 0 to 7 as follows: 0=not assessed, 1=normal, not ill at all, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill. The CGI Item 1 was completed during an interview between the participant and the investigator or designee. A negative change from Baseline indicates improvement.
Time Frame From Baseline to the end of the Maintenance Period (Day 106)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants from the Safety Set who had a valid IRLS score and a valid CGI Item 1 score at Baseline and a valid post-Baseline IRLS score and a valid post-Baseline CGI Item 1 score. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.
Arm/Group Title Placebo Rotigotine 2 mg/24h Rotigotine 3 mg/24h
Hide Arm/Group Description:
Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.
Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Overall Number of Participants Analyzed 5 7 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.0  (1.4) -1.7  (1.1) -0.8  (0.8)
3.Primary Outcome
Title Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Hide Description TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame.
Time Frame From Baseline to Safety Follow-Up (up to Week 20)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all participants from the Randomized Set (RS) who had at least one patch (rotigotine or placebo) applied.
Arm/Group Title Placebo Rotigotine 2 mg/24h Rotigotine 3 mg/24h
Hide Arm/Group Description:
Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.
Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Overall Number of Participants Analyzed 8 8 7
Measure Type: Number
Unit of Measure: percentage of participants
87.5 87.5 71.4
4.Primary Outcome
Title Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawals
Hide Description TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame.
Time Frame From Baseline to Safety Follow-Up (up to Week 20)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all participants from the RS who had at least one patch (rotigotine or placebo) applied.
Arm/Group Title Placebo Rotigotine 2 mg/24h Rotigotine 3 mg/24h
Hide Arm/Group Description:
Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.
Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Overall Number of Participants Analyzed 8 8 7
Measure Type: Number
Unit of Measure: percentage of participants
12.5 0 0
5.Secondary Outcome
Title Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period
Hide Description The RLS-6 Rating Scales was designed to assess the severity of RLS and consisted of 6 subscales. The subscales assessed severity of symptoms at the following times of the day/evening: falling asleep, during the night, during the day at rest, and during the day when engaged in daytime activities. In addition, the subscales assessed satisfaction with sleep and severity of daytime tiredness/sleepiness. Scores for each of the 6 subscales ranged from 0 (completely satisfied) to 10 (completely dissatisfied). The change from baseline was derived for each of the subscales and reported in this outcome measure. A negative change from Baseline indicates improvement.
Time Frame From Baseline to the end of the Maintenance Period (Day 106)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants from the Safety Set who had a valid IRLS score and a valid CGI Item 1 score at Baseline and a valid post-Baseline IRLS score and a valid post-Baseline CGI Item 1 score. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.
Arm/Group Title Placebo Rotigotine 2 mg/24h Rotigotine 3 mg/24h
Hide Arm/Group Description:
Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.
Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Overall Number of Participants Analyzed 5 7 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
Satisfaction with sleep -1.8  (4.1) -4.7  (2.3) -2.0  (2.8)
Severity: RLS symptoms at falling asleep -2.8  (3.6) -5.6  (1.6) -2.8  (1.8)
Severity: RLS symptoms during the night -1.0  (2.5) -2.9  (3.0) -2.4  (2.2)
Severity: RLS symptoms during the day - at rest -1.4  (1.3) -3.6  (3.5) -2.4  (2.6)
Severity: RLS symptoms during the day-not at rest -3.8  (1.9) -4.3  (3.5) -0.4  (1.1)
How tired or sleepy during the day -3.0  (2.8) -5.6  (2.1) -3.0  (1.9)
Time Frame From Baseline to Safety Follow-Up (up to Week 20)
Adverse Event Reporting Description TEAEs were defined as events that started during Treatment Period or within 30 days following the end of Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where intensity worsened within this time frame. TEAEs were analyzed for Safety Set.
 
Arm/Group Title Placebo Rotigotine 2 mg/24h Rotigotine 3 mg/24h
Hide Arm/Group Description Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period. Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period. Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
All-Cause Mortality
Placebo Rotigotine 2 mg/24h Rotigotine 3 mg/24h
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/8 (0.00%)      0/7 (0.00%)    
Hide Serious Adverse Events
Placebo Rotigotine 2 mg/24h Rotigotine 3 mg/24h
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)      1/7 (14.29%)    
Metabolism and nutrition disorders       
Type 2 diabetes mellitus * 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
1
Term from vocabulary, MedDRA 25.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Rotigotine 2 mg/24h Rotigotine 3 mg/24h
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/8 (87.50%)      7/8 (87.50%)      5/7 (71.43%)    
Blood and lymphatic system disorders       
Lymphadenopathy * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Ear and labyrinth disorders       
Vertigo * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Eye disorders       
Eye pain * 1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Gastrointestinal disorders       
Nausea * 1  1/8 (12.50%)  1 2/8 (25.00%)  4 0/7 (0.00%)  0
Vomiting * 1  1/8 (12.50%)  1 2/8 (25.00%)  2 0/7 (0.00%)  0
Diarrhoea * 1  0/8 (0.00%)  0 1/8 (12.50%)  2 0/7 (0.00%)  0
Haemorrhoids * 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Abdominal pain * 1  2/8 (25.00%)  2 0/8 (0.00%)  0 0/7 (0.00%)  0
General disorders       
Application site erythema * 1  1/8 (12.50%)  2 4/8 (50.00%)  5 1/7 (14.29%)  1
Application site pruritus * 1  0/8 (0.00%)  0 3/8 (37.50%)  3 1/7 (14.29%)  1
Application site irritation * 1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Application site pain * 1  1/8 (12.50%)  1 1/8 (12.50%)  1 0/7 (0.00%)  0
Fatigue * 1  1/8 (12.50%)  1 1/8 (12.50%)  1 0/7 (0.00%)  0
Asthenia * 1  1/8 (12.50%)  2 0/8 (0.00%)  0 0/7 (0.00%)  0
Immune system disorders       
Seasonal allergy * 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Infections and infestations       
Upper respiratory tract infection * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 3/7 (42.86%)  3
Gastroenteritis viral * 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Nasopharyngitis * 1  2/8 (25.00%)  2 0/8 (0.00%)  0 0/7 (0.00%)  0
Injury, poisoning and procedural complications       
Skin abrasion * 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Wound * 1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Investigations       
Serum ferritin decreased * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Thyroid function test abnormal * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Transferrin saturation decreased * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders       
Headache * 1  0/8 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  4
Dizziness * 1  2/8 (25.00%)  2 0/8 (0.00%)  0 1/7 (14.29%)  1
Migraine * 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Psychiatric disorders       
Attention deficit hyperactivity disorder * 1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
Insomnia * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Reproductive system and breast disorders       
Amenorrhoea * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Upper-airway cough syndrome * 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Dyspnoea * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pruritus * 1  0/8 (0.00%)  0 2/8 (25.00%)  2 1/7 (14.29%)  1
Skin irritation * 1  0/8 (0.00%)  0 2/8 (25.00%)  3 0/7 (0.00%)  0
Urticaria papular * 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1
Eczema * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0
Surgical and medical procedures       
Wisdom teeth removal * 1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA 25.1
*
Indicates events were collected by non-systematic assessment
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
Organization: Cares
Phone: 001 844 599 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier: NCT03728933    
Other Study ID Numbers: SP1006
First Submitted: October 31, 2018
First Posted: November 2, 2018
Results First Submitted: October 5, 2023
Results First Posted: October 26, 2023
Last Update Posted: October 26, 2023