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Trial record 1 of 1 for:    NCT01498120
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Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome

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ClinicalTrials.gov Identifier: NCT01498120
Recruitment Status : Completed
First Posted : December 23, 2011
Results First Posted : September 21, 2016
Last Update Posted : August 1, 2017
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: Treatment
Condition Restless Legs Syndrome
Intervention Drug: Rotigotine
Enrollment 14
Recruitment Details This study started to enroll subjects in USA in January 2012 and concluded in December 2015.
Pre-assignment Details Participant Flow refers to the Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication.
Arm/Group Title Rotigotine
Hide Arm/Group Description Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
Period Title: Overall Study
Started 14
Completed 1
Not Completed 13
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             5
AE, non-serious non-fatal             3
Other             4
Arm/Group Title Rotigotine
Hide Arm/Group Description Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
14
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
15.4  (1.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
10
  71.4%
Male
4
  28.6%
1.Primary Outcome
Title Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study
Hide Description An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame Visit 1 (Day 1) through End of Study (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Arm/Group Title Rotigotine (Safety Set)
Hide Arm/Group Description:
The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: subjects
3
2.Primary Outcome
Title Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study
Hide Description An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame From Visit 1 (Day 1) through End of Study (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Arm/Group Title Rotigotine (Safety Set)
Hide Arm/Group Description:
The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: subjects
10
Time Frame Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months).
Adverse Event Reporting Description All enrolled subjects who received at least 1 dose of study medication were included in the SS.
 
Arm/Group Title Rotigotine (Safety Set)
Hide Arm/Group Description The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
All-Cause Mortality
Rotigotine (Safety Set)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Rotigotine (Safety Set)
Affected / at Risk (%) # Events
Total   0/14 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rotigotine (Safety Set)
Affected / at Risk (%) # Events
Total   10/14 (71.43%)    
Cardiac disorders   
Palpitations * 1  1/14 (7.14%)  1
Sinus tachycardia * 1  1/14 (7.14%)  1
Gastrointestinal disorders   
Food poisoning * 1  1/14 (7.14%)  1
Nausea * 1  4/14 (28.57%)  7
Vomiting * 1  3/14 (21.43%)  6
General disorders   
Application site pruritus * 1  1/14 (7.14%)  1
Febrile disorders * 1  1/14 (7.14%)  1
Pyrexia * 1  1/14 (7.14%)  1
Oedema peripheral * 1  1/14 (7.14%)  1
Non-cardiac chest pain * 1  1/14 (7.14%)  1
Infections and infestations   
Ear infection * 1  1/14 (7.14%)  1
Streptococcal infection * 1  1/14 (7.14%)  1
Upper respiratory tract infection * 1  3/14 (21.43%)  3
Sinusitis * 1  1/14 (7.14%)  1
Urinary tract infection * 1  2/14 (14.29%)  2
Injury, poisoning and procedural complications   
Joint sprain * 1  1/14 (7.14%)  1
Road traffic accident * 1  1/14 (7.14%)  1
Sunburn * 1  1/14 (7.14%)  1
Contusion * 1  1/14 (7.14%)  1
Investigations   
Electrocardiogram QT corrected interval prolonged * 1  1/14 (7.14%)  1
Blood sodium increased * 1  1/14 (7.14%)  1
Toxicology laboratory analyses * 1  1/14 (7.14%)  1
Drug screen positive * 1  1/14 (7.14%)  1
Metabolism and nutrition disorders   
Dehydration * 1  1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/14 (7.14%)  1
Myalgia * 1  1/14 (7.14%)  1
Nervous system disorders   
Syncope * 1  1/14 (7.14%)  1
Syncope vasovagal * 1  1/14 (7.14%)  1
Headache * 1  1/14 (7.14%)  3
Dizziness * 1  1/14 (7.14%)  1
Presyncope * 1  1/14 (7.14%)  1
Sudden onset of sleep * 1  1/14 (7.14%)  2
Psychiatric disorders   
Anxiety * 1  1/14 (7.14%)  1
Renal and urinary disorders   
Enuresis * 1  1/14 (7.14%)  1
Haematuria * 1  1/14 (7.14%)  1
Reproductive system and breast disorders   
Dysmenorrhoea * 1  1/14 (7.14%)  1
Skin and subcutaneous tissue disorders   
Pruritus * 1  1/14 (7.14%)  1
Dermal cyst * 1  1/14 (7.14%)  1
Vascular disorders   
Orthostatic hypotension * 1  1/14 (7.14%)  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: Clinical Trial Registries and Results Disclosure
Organization: UCB BIOSCIENCES GmbH
Phone: 40789+49 2173 48 ext 15 15
EMail: clinicaltrials@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT01498120    
Other Study ID Numbers: SP1005
First Submitted: December 16, 2011
First Posted: December 23, 2011
Results First Submitted: August 1, 2016
Results First Posted: September 21, 2016
Last Update Posted: August 1, 2017