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Trial record 1 of 1 for:    NCT00498186
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Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)

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ClinicalTrials.gov Identifier: NCT00498186
Recruitment Status : Completed
First Posted : July 9, 2007
Results First Posted : April 13, 2010
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

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 295
Recruitment Details A total of 295 subjects belong to the Enrolled Set (ES) and all of them received at least one dose of trial medication, so they all belong to the Safety Set (SS).
Pre-assignment Details Participant Flow information and Baseline Characteristics belong to the Safety Set (SS).
Arm/Group Title Rotigotine
Hide Arm/Group Description Rotigotine trans-dermal patch
Period Title: Overall Study
Started 295
Completed 122
Not Completed 173
Reason Not Completed
Protocol Violation             10
Lack of Efficacy             31
Adverse Event             89
Unsatisfactory compliance of subject             12
Withdrawal by Subject             18
Lost to Follow-up             3
Other             10
Arm/Group Title Rotigotine
Hide Arm/Group Description Rotigotine trans-dermal patch
Overall Number of Baseline Participants 295
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants
<=18 years
0
   0.0%
Between 18 and 65 years
208
  70.5%
>=65 years
87
  29.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 295 participants
58.3  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants
Female
196
  66.4%
Male
99
  33.6%
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/ m^2
Number Analyzed 295 participants
26.37  (3.84)
[1]
Measure Description: BMI= weight/height^2
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 295 participants
167.5  (8.3)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 295 participants
74.21  (13.19)
1.Primary Outcome
Title Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.
Hide Description Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame Up to five years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 295 subjects who entered the study, 295 are included in this summary based on the Safety Set (SS).
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Rotigotine trans-dermal patch
Overall Number of Participants Analyzed 295
Measure Type: Number
Unit of Measure: participants
273
2.Secondary Outcome
Title Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension
Hide Description Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame Up to five years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 295 subjects who entered the study, 295 are included in this summary based on the Safety Set (SS).
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Rotigotine trans-dermal patch
Overall Number of Participants Analyzed 295
Measure Type: Number
Unit of Measure: participants
93
Time Frame Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Adverse Event Reporting Description Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
 
Arm/Group Title Rotigotine
Hide Arm/Group Description Rotigotine trans-dermal patch
All-Cause Mortality
Rotigotine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Rotigotine
Affected / at Risk (%) # Events
Total   79/295 (26.78%)    
Blood and lymphatic system disorders   
Lymphadenopathy * 1  1/295 (0.34%)  1
Cardiac disorders   
Coronary artery disease * 1  2/295 (0.68%)  2
Cardiac failure * 1  1/295 (0.34%)  1
Myocardial infarction * 1  4/295 (1.36%)  5
Angina pectoris * 1  1/295 (0.34%)  1
Pericardial haemorrhage * 1  1/295 (0.34%)  1
Bradycardia * 1  1/295 (0.34%)  1
Tachycardia * 1  1/295 (0.34%)  1
Tricuspid valve incompetence * 1  1/295 (0.34%)  1
Endocrine disorders   
Goitre * 1  2/295 (0.68%)  2
Eye disorders   
Diplopia * 1  1/295 (0.34%)  1
Gastrointestinal disorders   
Gastric ulcer haemorrhage * 1  1/295 (0.34%)  1
Abdominal pain * 1  1/295 (0.34%)  1
Inguinal hernia * 1  1/295 (0.34%)  1
Nausea * 1  2/295 (0.68%)  2
Haematochezia * 1  1/295 (0.34%)  1
General disorders   
Fatigue * 1  1/295 (0.34%)  1
Hernia * 1  1/295 (0.34%)  1
Inflammation * 1  1/295 (0.34%)  1
Cyst * 1  1/295 (0.34%)  1
Necrosis * 1  1/295 (0.34%)  1
Oedema peripheral * 1  1/295 (0.34%)  1
Hepatobiliary disorders   
Cholecystitis acute * 1  1/295 (0.34%)  1
Infections and infestations   
Appendicitis * 1  1/295 (0.34%)  1
Gastroenteritis * 1  1/295 (0.34%)  1
Perianal abscess * 1  1/295 (0.34%)  1
Lower respiratory tract infection * 1  1/295 (0.34%)  1
Pneumonia * 1  1/295 (0.34%)  1
Pyelonephritis * 1  1/295 (0.34%)  1
Pyelonephritis chronic * 1  1/295 (0.34%)  1
Injury, poisoning and procedural complications   
Concussion * 1  1/295 (0.34%)  1
Comminuted fracture * 1  1/295 (0.34%)  1
Joint dislocation * 1  1/295 (0.34%)  1
Multiple fractures * 1  1/295 (0.34%)  1
Meniscus lesion * 1  1/295 (0.34%)  1
Ankle fracture * 1  1/295 (0.34%)  1
Tendon rupture * 1  1/295 (0.34%)  1
Incisional hernia * 1  1/295 (0.34%)  1
Facial bones fracture * 1  1/295 (0.34%)  1
Radius fracture * 1  3/295 (1.02%)  3
Investigations   
Blood pressure increased * 1  1/295 (0.34%)  2
Musculoskeletal and connective tissue disorders   
Chondropathy * 1  1/295 (0.34%)  1
Toe deformity * 1  4/295 (1.36%)  4
Intervertebral disc disorder * 1  1/295 (0.34%)  1
Intervertebral disc protrusion * 1  1/295 (0.34%)  1
Impingement syndrome * 1  1/295 (0.34%)  1
Periarthritis * 1  1/295 (0.34%)  1
Rotator cuff syndrome * 1  1/295 (0.34%)  1
Arthralgia * 1  1/295 (0.34%)  1
Muscle tightness * 1  1/295 (0.34%)  1
Back pain * 1  1/295 (0.34%)  1
Osteoarthritis * 1  11/295 (3.73%)  13
Lumbal spinal stenosis * 1  1/295 (0.34%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Salivary gland adenoma * 1  1/295 (0.34%)  1
Colon adenoma * 1  1/295 (0.34%)  1
Plasmacytoma * 1  1/295 (0.34%)  1
Prostate cancer * 1  1/295 (0.34%)  1
Bladder neoplasm * 1  1/295 (0.34%)  1
Uterine leiomyoma * 1  3/295 (1.02%)  3
Nervous system disorders   
Polyneuropathy * 1  1/295 (0.34%)  1
Cerebellar infarction * 1  1/295 (0.34%)  1
Cerebral ischaemia * 1  1/295 (0.34%)  1
Cerebrovascular accident * 1  1/295 (0.34%)  1
Syncope * 1  3/295 (1.02%)  3
Depressed level of consciousness * 1  1/295 (0.34%)  1
Tension headache * 1  1/295 (0.34%)  1
Migraine * 1  1/295 (0.34%)  1
Presyncope * 1  1/295 (0.34%)  1
Restless legs syndrome * 1  1/295 (0.34%)  1
Pregnancy, puerperium and perinatal conditions   
Abortion * 1  1/295 (0.34%)  1
Renal and urinary disorders   
Bladder prolapse * 1  1/295 (0.34%)  1
Respiratory, thoracic and mediastinal disorders   
Sleep apnoe syndrome * 1  2/295 (0.68%)  2
Pleurisy * 1  1/295 (0.34%)  1
Surgical and medical procedures   
Abdominoplasty * 1  1/295 (0.34%)  1
Bladder operation * 1  1/295 (0.34%)  1
Hip arthroplasty * 1  2/295 (0.68%)  2
Limb operation * 1  1/295 (0.34%)  1
Hysterectomy * 1  1/295 (0.34%)  1
Angioplasty * 1  1/295 (0.34%)  1
Vascular disorders   
Arterial occlusive disease * 1  1/295 (0.34%)  1
Arteriosclerosis * 1  1/295 (0.34%)  1
Vascular occlusion * 1  1/295 (0.34%)  1
Deep vein thrombosis * 1  1/295 (0.34%)  1
Varicose vein * 1  3/295 (1.02%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rotigotine
Affected / at Risk (%) # Events
Total   272/295 (92.20%)    
Gastrointestinal disorders   
Nausea * 1  35/295 (11.86%)  44
General disorders   
Application site erythema * 1  96/295 (32.54%)  132
Application site reaction * 1  74/295 (25.08%)  90
Application site pruritus * 1  54/295 (18.31%)  71
Fatigue * 1  31/295 (10.51%)  36
Infections and infestations   
Influenza * 1  15/295 (5.08%)  17
Bronchitis * 1  20/295 (6.78%)  26
Nasopharyngitis * 1  55/295 (18.64%)  78
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  21/295 (7.12%)  25
Back pain * 1  40/295 (13.56%)  50
Osteoarthritis * 1  19/295 (6.44%)  19
Nervous system disorders   
Headache * 1  16/295 (5.42%)  21
Dizziness * 1  16/295 (5.42%)  20
Psychiatric disorders   
Depression * 1  22/295 (7.46%)  25
Insomnia * 1  17/295 (5.76%)  18
Sleep disorder * 1  21/295 (7.12%)  22
Skin and subcutaneous tissue disorders   
Erythemas * 1  17/295 (5.76%)  17
Pruritus * 1  15/295 (5.08%)  16
Vascular disorders   
Hypertension * 1  26/295 (8.81%)  28
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493 (UCB)
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00498186    
Other Study ID Numbers: SP0710
First Submitted: July 6, 2007
First Posted: July 9, 2007
Results First Submitted: March 23, 2010
Results First Posted: April 13, 2010
Last Update Posted: October 2, 2014