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Trial record 1 of 1 for:    NCT00501969
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An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease

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: NCT00501969
Recruitment Status : Completed
First Posted : July 17, 2007
Results First Posted : January 12, 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 Advanced Stage Parkinson's Disease
Intervention Drug: Rotigotine
Enrollment 395
Recruitment Details An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects with Advanced-Stage Idiopathic Parkinson’s Disease who are not well controlled on L-Dopa from August 2004 to December 2008
Pre-assignment Details  
Arm/Group Title Rotigotine
Hide Arm/Group Description Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
Period Title: Overall Study
Started 395
Completed 189
Not Completed 206
Reason Not Completed
Major Protocol Violation             4
Lack of Efficacy             29
Adverse Event             76
Unsatisfactory compliance of subject             7
Subject withdrew consent             51
Lost to Follow-up             4
Other: Tired Of Clinical Trial Process             1
Other: Sponsors Request             10
Other: Sponsor Termination at Site             1
Other: Sponsor Stopped Study             12
Other: Severe Dementia Unable Sign PIC             1
Other: Patients + Investigator Agreement             1
Other: Patient is Going to Have DBS             1
Other: Pat Pending Surgery for PD             1
Other: DX Changed - Parkinsons to PSNP             1
Other: As Required by Local EC             2
Other: Admin Request from the Sponsor             3
Other: Sponsor Termination/Commercial RX             1
Arm/Group Title Rotigotine
Hide Arm/Group Description Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
Overall Number of Baseline Participants 395
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 395 participants
<=18 years
0
   0.0%
Between 18 and 65 years
183
  46.3%
>=65 years
212
  53.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 395 participants
64.4  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 395 participants
Female
144
  36.5%
Male
251
  63.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 395 participants
Finland 8
Spain 35
Austria 6
Israel 22
United Kingdom 10
Italy 33
France 9
Czech Republic 50
Hungary 11
Poland 65
Croatia 27
Australia 30
South Africa 52
Germany 4
Norway 8
New Zealand 16
Sweden 9
1.Primary Outcome
Title Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
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 five years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
Overall Number of Participants Analyzed 395
Measure Type: Number
Unit of Measure: Subjects
357
2.Secondary Outcome
Title Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
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 five years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
Overall Number of Participants Analyzed 395
Measure Type: Number
Unit of Measure: Subjects
76
3.Secondary Outcome
Title Mean Epworth Sleepiness Scale Score During the Open-label Extension
Hide Description The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.
Time Frame Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
Overall Number of Participants Analyzed 395
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Visit 13 (end of year 1) (n=377) 7.4  (4.7)
Visit 17 (end of year 2) (n=377) 7.8  (5.1)
Visit 21 (end of year 3) (n=377) 8.0  (5.1)
Visit 25 (end of year 4) (n=377) 8.3  (5.2)
Time Frame Up to five years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rotigotine
Hide Arm/Group Description Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
All-Cause Mortality
Rotigotine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Rotigotine
Affected / at Risk (%) # Events
Total   148/395 (37.47%)    
Blood and lymphatic system disorders   
Anaemia * 1  2/395 (0.51%)  2
Haemorrhagic anaemia * 1  1/395 (0.25%)  1
Cardiac disorders   
Myocardial infarction * 1  3/395 (0.76%)  3
Myocardial ischaemia * 1  2/395 (0.51%)  2
Angina pectoris * 1  1/395 (0.25%)  1
Cardiac failure * 1  4/395 (1.01%)  4
Sick sinus syndrome * 1  2/395 (0.51%)  2
Atrial fibrillation * 1  2/395 (0.51%)  2
Coronary artery disease * 1  3/395 (0.76%)  3
Cardiac arrest * 1  1/395 (0.25%)  1
Ischaemic cardiomyopathy * 1  1/395 (0.25%)  1
Ear and labyrinth disorders   
Vertigo positional * 1  1/395 (0.25%)  1
Endocrine disorders   
Toxic nodular goitre * 1  1/395 (0.25%)  1
Eye disorders   
Keratoconus * 1  1/395 (0.25%)  1
Maculopathy * 1  1/395 (0.25%)  1
Gastrointestinal disorders   
Inguinal hernia * 1  2/395 (0.51%)  2
Gastric perforation * 1  1/395 (0.25%)  1
Gastric ulcer haemorrhage * 1  1/395 (0.25%)  1
Rectal prolapse * 1  1/395 (0.25%)  1
Gastric polyps * 1  1/395 (0.25%)  1
Periodontitis * 1  1/395 (0.25%)  1
Dysphagia * 1  1/395 (0.25%)  1
Intestinal obstruction * 1  1/395 (0.25%)  1
Haemorrhoids * 1  1/395 (0.25%)  1
Gastrointestinal haemorrhage * 1  1/395 (0.25%)  1
Small intestinal obstruction * 1  1/395 (0.25%)  1
Duodenal ulcer haemorrhage * 1  1/395 (0.25%)  1
Diarrhoea * 1  1/395 (0.25%)  1
Vomiting * 1  1/395 (0.25%)  1
General disorders   
Chest pain * 1  3/395 (0.76%)  3
Application site reaction * 1  2/395 (0.51%)  2
Gait disturbance * 1  2/395 (0.51%)  2
Unevaluable event * 1  1/395 (0.25%)  1
Pyrexia * 1  1/395 (0.25%)  1
Hernia * 1  1/395 (0.25%)  1
Implant site haematoma * 1  1/395 (0.25%)  1
Hepatobiliary disorders   
Cholelithiasis * 1  1/395 (0.25%)  1
Cholangitis * 1  1/395 (0.25%)  1
Immune system disorders   
Transplant rejection * 1  1/395 (0.25%)  1
Infections and infestations   
Pneumonia * 1  7/395 (1.77%)  8
Bronchitis acute * 1  1/395 (0.25%)  1
Lobar pneumonia * 1  1/395 (0.25%)  1
Urinary tract infection * 1  5/395 (1.27%)  5
Cellulitis * 1  3/395 (0.76%)  3
Arthritis infective * 1  1/395 (0.25%)  1
Intervertebral discitis * 1  1/395 (0.25%)  1
Gastroenteritis * 1  1/395 (0.25%)  1
Sepsis * 1  1/395 (0.25%)  1
Gastroenteritis viral * 1  1/395 (0.25%)  1
Lower respiratory tract infection viral * 1  1/395 (0.25%)  1
Erysipelas * 1  1/395 (0.25%)  1
Abscess * 1  1/395 (0.25%)  1
Injury, poisoning and procedural complications   
Femoral neck fracture * 1  3/395 (0.76%)  3
Hip fracture * 1  2/395 (0.51%)  2
Femur fracture * 1  2/395 (0.51%)  2
Patella fracture * 1  1/395 (0.25%)  1
Tibia fracture * 1  1/395 (0.25%)  1
Fall * 1  4/395 (1.01%)  4
Wound * 1  1/395 (0.25%)  1
Road traffic accident * 1  1/395 (0.25%)  1
Radius fracture * 1  2/395 (0.51%)  2
Upper limb fracture * 1  1/395 (0.25%)  1
Forearm fracture * 1  1/395 (0.25%)  1
Joint dislocation * 1  1/395 (0.25%)  1
Traumatic fracture * 1  1/395 (0.25%)  1
Comminuted fracture * 1  1/395 (0.25%)  1
Joint injury * 1  1/395 (0.25%)  1
Meniscus lesion * 1  1/395 (0.25%)  1
Concussion * 1  1/395 (0.25%)  1
Narcotic intoxication * 1  1/395 (0.25%)  1
Head injury * 1  1/395 (0.25%)  1
Skin laceration * 1  1/395 (0.25%)  1
Overdose * 1  1/395 (0.25%)  1
Post procedural complication * 1  1/395 (0.25%)  1
Pelvic fracture * 1  1/395 (0.25%)  1
Skull fracture * 1  1/395 (0.25%)  1
Spinal compression fracture * 1  1/395 (0.25%)  1
Tendon rupture * 1  1/395 (0.25%)  1
Investigations   
Hepatic enzyme increased * 1  1/395 (0.25%)  1
Metabolism and nutrition disorders   
Diabetes mellitus non-insulin-dependent * 1  1/395 (0.25%)  1
Musculoskeletal and connective tissue disorders   
Osteoarthritis * 1  4/395 (1.01%)  5
Spinal osteoarthritis * 1  1/395 (0.25%)  1
Arthralgia * 1  4/395 (1.01%)  4
Back pain * 1  2/395 (0.51%)  2
Pain in extremity * 1  1/395 (0.25%)  1
Arthropathy * 1  2/395 (0.51%)  2
Bursa disorder * 1  1/395 (0.25%)  1
Synovitis * 1  1/395 (0.25%)  1
Rheumatoid arthritis * 1  1/395 (0.25%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer * 1  2/395 (0.51%)  2
Bronchial carcinoma * 1  2/395 (0.51%)  2
Squamous cell carcinoma * 1  1/395 (0.25%)  1
Metastatic neoplasm * 1  1/395 (0.25%)  1
Malignant neoplasm of spinal cord * 1  1/395 (0.25%)  1
Non-Hodgkin's lymphoma * 1  1/395 (0.25%)  1
Colon neoplasm * 1  1/395 (0.25%)  1
Lung neoplasm * 1  1/395 (0.25%)  1
B-cell lymphoma * 1  1/395 (0.25%)  1
Bladder neoplasm * 1  1/395 (0.25%)  1
Nervous system disorders   
Parkinson's disease * 1  18/395 (4.56%)  22
Parkinsonism * 1  4/395 (1.01%)  5
Cerebral haemorrhage * 1  3/395 (0.76%)  3
Cerebrovascular accident * 1  2/395 (0.51%)  2
Subarachnoid haemorrhage * 1  1/395 (0.25%)  1
Syncope * 1  3/395 (0.76%)  3
Loss of consciousness * 1  2/395 (0.51%)  2
Radicular pain * 1  1/395 (0.25%)  1
Cauda equina syndrome * 1  1/395 (0.25%)  1
Dyskinesia * 1  2/395 (0.51%)  2
Transient ischaemic attack * 1  2/395 (0.51%)  2
Sciatica * 1  2/395 (0.51%)  4
Dementia * 1  1/395 (0.25%)  1
Monoparesis * 1  1/395 (0.25%)  1
Neuropathy peripheral * 1  1/395 (0.25%)  1
Tremor * 1  1/395 (0.25%)  1
Convulsion * 1  1/395 (0.25%)  1
Sudden onset of sleep * 1  1/395 (0.25%)  1
Dysphasia * 1  1/395 (0.25%)  1
Psychiatric disorders   
Hallucination * 1  4/395 (1.01%)  4
Hallucination, visual * 1  4/395 (1.01%)  4
Delirium * 1  2/395 (0.51%)  2
Obsessive-compulsive disorder * 1  1/395 (0.25%)  1
Sleep attacks * 1  1/395 (0.25%)  1
Delusional disorder, persecutory type * 1  1/395 (0.25%)  1
Major depression * 1  1/395 (0.25%)  1
Pathological gambling * 1  1/395 (0.25%)  2
Psychotic disorder * 1  1/395 (0.25%)  1
Suicidal ideation * 1  1/395 (0.25%)  1
Renal and urinary disorders   
Urinary retention * 1  6/395 (1.52%)  7
Haematuria * 1  3/395 (0.76%)  3
Nephrolithiasis * 1  1/395 (0.25%)  1
Bladder disorder * 1  1/395 (0.25%)  1
Renal colic * 1  1/395 (0.25%)  1
Reproductive system and breast disorders   
Benign prostatic hyperplasia * 1  3/395 (0.76%)  3
Cystocele * 1  1/395 (0.25%)  1
Uterine prolapse * 1  1/395 (0.25%)  1
Prostatism * 1  1/395 (0.25%)  1
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease * 1  2/395 (0.51%)  4
Asthma * 1  1/395 (0.25%)  1
Pulmonary embolism * 1  3/395 (0.76%)  3
Dyspnoea * 1  1/395 (0.25%)  1
Pneumonia aspiration * 1  1/395 (0.25%)  1
Respiratory failure * 1  1/395 (0.25%)  1
Surgical and medical procedures   
Deep brain stimulation * 1  3/395 (0.76%)  3
Knee arthroplasty * 1  3/395 (0.76%)  3
Drug therapy changed * 1  1/395 (0.25%)  1
Rehabilitation therapy * 1  1/395 (0.25%)  1
Cataract operation * 1  1/395 (0.25%)  1
Spinal operation * 1  1/395 (0.25%)  1
Open reduction of fracture * 1  1/395 (0.25%)  1
Vascular disorders   
Deep vein thrombosis * 1  3/395 (0.76%)  3
Thrombophlebitis * 1  1/395 (0.25%)  1
Orthostatic hypotension * 1  1/395 (0.25%)  1
Cardiovascular insufficiency * 1  1/395 (0.25%)  2
Haematoma * 1  1/395 (0.25%)  1
Hypertension * 1  1/395 (0.25%)  1
Circulatory collapse * 1  1/395 (0.25%)  2
Aortic aneurysm * 1  1/395 (0.25%)  1
*
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   305/395 (77.22%)    
Gastrointestinal disorders   
Nausea * 1  54/395 (13.67%)  62
Constipation * 1  26/395 (6.58%)  29
General disorders   
Application site erythema * 1  40/395 (10.13%)  45
Application site pruritus * 1  38/395 (9.62%)  39
Application site reaction * 1  29/395 (7.34%)  32
Oedema peripheral * 1  33/395 (8.35%)  35
Infections and infestations   
Urinary tract infection * 1  27/395 (6.84%)  46
Injury, poisoning and procedural complications   
Fall * 1  61/395 (15.44%)  117
Investigations   
Weight decreased * 1  43/395 (10.89%)  52
Weight increased * 1  30/395 (7.59%)  32
Musculoskeletal and connective tissue disorders   
Back pain * 1  48/395 (12.15%)  57
Arthralgia * 1  32/395 (8.10%)  36
Nervous system disorders   
Somnolence * 1  133/395 (33.67%)  170
Dyskinesia * 1  55/395 (13.92%)  74
Parkinson's disease * 1  44/395 (11.14%)  52
Dizziness * 1  27/395 (6.84%)  31
Headache * 1  27/395 (6.84%)  33
Psychiatric disorders   
Hallucination * 1  32/395 (8.10%)  35
Hallucination, visual * 1  20/395 (5.06%)  27
Insomnia * 1  45/395 (11.39%)  52
Depression * 1  31/395 (7.85%)  33
Abnormal dreams * 1  20/395 (5.06%)  23
Vascular disorders   
Orthostatic hypotension * 1  20/395 (5.06%)  21
Hypertension * 1  24/395 (6.08%)  26
*
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
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00501969    
Other Study ID Numbers: SP0516
2004-000148-26 ( EudraCT Number )
First Submitted: July 16, 2007
First Posted: July 17, 2007
Results First Submitted: December 8, 2009
Results First Posted: January 12, 2010
Last Update Posted: October 2, 2014