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Trial record 1 of 1 for:    NCT00599196
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An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-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: NCT00599196
Recruitment Status : Completed
First Posted : January 23, 2008
Results First Posted : January 18, 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 Early Stage Parkinson's Disease
Intervention Drug: Rotigotine
Enrollment 381
Recruitment Details An Open-Label Extension to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects with Early-Stage Idiopathic Parkinson's Disease from August 2002 to December 2008
Pre-assignment Details One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.
Arm/Group Title Rotigotine
Hide Arm/Group Description Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
Period Title: Overall Study
Started 381
Completed 0 [1]
Not Completed 381
Reason Not Completed
Lack of Efficacy             22
Adverse Event             93
Unsatisfactory compliance of subject             3
Subject withdrew consent             43
Study ended per sponsor             197
Lost to Follow-up             17
Other: Patient Leaving For Israel             1
Other: Spouse Withdrew Consent             1
Other: Diagnosis No Longer Idiopathic Pd             1
Other: Pt Moved To Australia             1
Other: Patient Stopped Due To Moving             1
Other: Inv Switched Dopamine Agonist             1
[1]
Study fully recruited. Completed upon market authorization and commercial availability of Neupro.
Arm/Group Title Rotigotine
Hide Arm/Group Description Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
Overall Number of Baseline Participants 380
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 380 participants
<=18 years
0
   0.0%
Between 18 and 65 years
215
  56.6%
>=65 years
165
  43.4%
[1]
Measure Description: Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the Safety Set because he withdrew consent prior to receiving any Open Label study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 380 participants
61.6  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 380 participants
Female
150
  39.5%
Male
230
  60.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 380 participants
Finland 16
Spain 10
Austria 12
Israel 30
United Kingdom 38
Italy 9
Switzerland 4
France 10
Czech Republic 44
Hungary 17
Poland 65
Belgium 12
Croatia 17
Australia 7
South Africa 42
Germany 7
Norway 4
Netherlands 5
New Zealand 19
Sweden 12
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 six years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
Overall Number of Participants Analyzed 380
Measure Type: Number
Unit of Measure: Subjects
369
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 six years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
Overall Number of Participants Analyzed 380
Measure Type: Number
Unit of Measure: Subjects
93
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 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 380 subjects who are included in the Safety Set (SS), 5 subjects discontinued prior to entering the maintenance phase (n=375), however 2 of these subjects returned for the End of Treatment visit (n=377). Last observation carried forward (LOCF) was utilized for subjects who entered the maintenance phase.
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
Overall Number of Participants Analyzed 377
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Visit 10 (end of year 1) (n=375) 5.8  (3.8)
Visit 14 (end of year 2) (n=375) 6.2  (4.1)
Visit 18 (end of year 3) (n=375) 6.7  (4.5)
Visit 22 (end of year 4) (n=375) 6.7  (4.6)
Visit 26 (end of year 5) (n=375) 6.7  (4.5)
Visit 30 (end of year 6) (n=375) 6.8  (4.5)
End of Treatment (n=377) 6.8  (4.5)
Time Frame up to 6 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rotigotine
Hide Arm/Group Description Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
All-Cause Mortality
Rotigotine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Rotigotine
Affected / at Risk (%) # Events
Total   131/380 (34.47%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/380 (0.26%)  1
Cardiac disorders   
Myocardial infarction * 1  10/380 (2.63%)  11
Angina pectoris * 1  2/380 (0.53%)  2
Angina unstable * 1  1/380 (0.26%)  1
Acute myocardial infarction * 1  1/380 (0.26%)  1
Atrial fibrillation * 1  2/380 (0.53%)  2
Ventricular arrhythmia * 1  2/380 (0.53%)  2
Ventricular extrasystoles * 1  1/380 (0.26%)  1
Cardiac failure * 1  1/380 (0.26%)  1
Cardiac failure acute * 1  1/380 (0.26%)  1
Coronary artery disease * 1  1/380 (0.26%)  1
Eye disorders   
Angle closure glaucoma * 1  1/380 (0.26%)  1
Cataract * 1  1/380 (0.26%)  1
Gastrointestinal disorders   
Inguinal hernia * 1  3/380 (0.79%)  3
Vomiting * 1  2/380 (0.53%)  2
Umbilical hernia * 1  2/380 (0.53%)  2
Gastric haemorrhage * 1  1/380 (0.26%)  1
Abdominal discomfort * 1  1/380 (0.26%)  1
Haemorrhoids * 1  1/380 (0.26%)  1
Volvulus * 1  1/380 (0.26%)  1
Diverticulum intestinal * 1  1/380 (0.26%)  1
Gastric ulcer * 1  1/380 (0.26%)  1
Gastric ulcer perforation * 1  1/380 (0.26%)  1
Gastritis * 1  1/380 (0.26%)  1
Abdominal pain * 1  1/380 (0.26%)  1
Constipation * 1  1/380 (0.26%)  1
Duodenitis * 1  1/380 (0.26%)  1
Irritable bowel syndrome * 1  1/380 (0.26%)  1
Intestinal infarction * 1  1/380 (0.26%)  1
Anal haemorrhage * 1  1/380 (0.26%)  1
Ileus paralytic * 1  1/380 (0.26%)  1
General disorders   
Application site irritation * 1  1/380 (0.26%)  1
Application site rash * 1  1/380 (0.26%)  1
Application site erythema * 1  1/380 (0.26%)  1
Gait disturbance * 1  2/380 (0.53%)  2
Hernia * 1  1/380 (0.26%)  1
Oedema peripheral * 1  1/380 (0.26%)  1
Therapeutic response decreased * 1  1/380 (0.26%)  1
Sudden death * 1  1/380 (0.26%)  1
Chest discomfort * 1  1/380 (0.26%)  1
Hepatobiliary disorders   
Cholelithiasis * 1  5/380 (1.32%)  5
Cholecystitis * 1  2/380 (0.53%)  2
Bile duct stone * 1  2/380 (0.53%)  2
Hepatic cyst * 1  1/380 (0.26%)  1
Biliary tract disorder * 1  1/380 (0.26%)  1
Immune system disorders   
Autoimmune disorder * 1  1/380 (0.26%)  1
Infections and infestations   
Pneumonia * 1  4/380 (1.05%)  4
Bronchitis acute * 1  1/380 (0.26%)  1
Lobar pneumonia * 1  1/380 (0.26%)  1
Postoperative wound infection * 1  2/380 (0.53%)  2
Infection * 1  1/380 (0.26%)  1
Wound infection * 1  1/380 (0.26%)  1
Sepsis * 1  2/380 (0.53%)  2
Urosepsis * 1  1/380 (0.26%)  1
Pyelonephritis * 1  1/380 (0.26%)  1
Urinary tract infection * 1  1/380 (0.26%)  2
Appendicitis * 1  1/380 (0.26%)  1
Gastroenteritis * 1  1/380 (0.26%)  1
Meningoencephalitis herpetic * 1  1/380 (0.26%)  1
Orchitis * 1  1/380 (0.26%)  1
Sinusitis * 1  1/380 (0.26%)  1
Tuberculosis * 1  1/380 (0.26%)  3
Influenza * 1  1/380 (0.26%)  1
Erysipelas * 1  1/380 (0.26%)  3
Viral infection * 1  1/380 (0.26%)  1
Injury, poisoning and procedural complications   
Fall * 1  9/380 (2.37%)  13
Road traffic accident * 1  2/380 (0.53%)  2
Femoral neck fracture * 1  6/380 (1.58%)  7
Femur fracture * 1  5/380 (1.32%)  5
Hip fracture * 1  1/380 (0.26%)  1
Patella fracture * 1  1/380 (0.26%)  1
Meniscus lesion * 1  2/380 (0.53%)  2
Limb injury * 1  1/380 (0.26%)  1
Joint injury * 1  1/380 (0.26%)  1
Cervical vertebral fracture * 1  1/380 (0.26%)  1
Thoracic vertebral fracture * 1  1/380 (0.26%)  1
Fractured coccyx * 1  1/380 (0.26%)  1
Spinal compression fracture * 1  1/380 (0.26%)  1
Contusion * 1  3/380 (0.79%)  3
Skin injury * 1  1/380 (0.26%)  2
Upper limb fracture * 1  1/380 (0.26%)  1
Humerus fracture * 1  1/380 (0.26%)  1
Rib fracture * 1  2/380 (0.53%)  2
Concussion * 1  1/380 (0.26%)  2
Post procedural haematoma * 1  1/380 (0.26%)  1
Tooth injury * 1  1/380 (0.26%)  1
Investigations   
Hepatic enzyme increased * 1  1/380 (0.26%)  1
Metabolism and nutrition disorders   
Hypoglycaemia * 1  1/380 (0.26%)  1
Diabetes mellitus * 1  1/380 (0.26%)  1
Musculoskeletal and connective tissue disorders   
Osteoarthritis * 1  11/380 (2.89%)  12
Spinal osteoarthritis * 1  1/380 (0.26%)  2
Arthritis * 1  1/380 (0.26%)  1
Arthropathy * 1  1/380 (0.26%)  1
Arthralgia * 1  2/380 (0.53%)  2
Muscle disorder * 1  1/380 (0.26%)  1
Bone pain * 1  1/380 (0.26%)  1
Toe deformity * 1  1/380 (0.26%)  1
Rhabdomyolysis * 1  1/380 (0.26%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer * 1  2/380 (0.53%)  3
Endometrial cancer * 1  1/380 (0.26%)  1
Lip and/or oral cavity cancer * 1  1/380 (0.26%)  1
Pancreatic carcinoma * 1  1/380 (0.26%)  1
Renal cell carcinoma stage unspecified * 1  1/380 (0.26%)  1
Ovarian neoplasm * 1  1/380 (0.26%)  1
Gastric neoplasm * 1  1/380 (0.26%)  1
Metastases to pleura * 1  1/380 (0.26%)  1
Acoustic neuroma * 1  1/380 (0.26%)  1
Keratoacanthoma * 1  1/380 (0.26%)  1
Colon adenoma * 1  1/380 (0.26%)  1
Lung neoplasm malignant * 1  1/380 (0.26%)  1
Phaeochromocytoma * 1  1/380 (0.26%)  1
Thyroid cancer * 1  1/380 (0.26%)  1
Syncope vasovagal * 1  1/380 (0.26%)  1
Dizziness * 1  2/380 (0.53%)  2
Nervous system disorders   
Parkinson's disease * 1  9/380 (2.37%)  10
Somnolence * 1  1/380 (0.26%)  1
Sudden onset of sleep * 1  1/380 (0.26%)  1
Transient ischaemic attack * 1  1/380 (0.26%)  1
Tremor * 1  1/380 (0.26%)  2
Cerebrovascular accident * 1  1/380 (0.26%)  1
Movement disorder * 1  1/380 (0.26%)  1
Headache * 1  1/380 (0.26%)  1
Myelitis transverse * 1  1/380 (0.26%)  1
Lumbar radiculopathy * 1  1/380 (0.26%)  1
Psychiatric disorders   
Hallucination * 1  4/380 (1.05%)  4
Hallucination, visual * 1  1/380 (0.26%)  1
Depression * 1  3/380 (0.79%)  3
Sleep attacks * 1  2/380 (0.53%)  3
Paranoia * 1  2/380 (0.53%)  2
Confusional state * 1  2/380 (0.53%)  2
Impulse-control disorder * 1  1/380 (0.26%)  1
Mania * 1  1/380 (0.26%)  1
Psychotic disorder * 1  1/380 (0.26%)  1
Renal and urinary disorders   
Stress urinary incontinence * 1  2/380 (0.53%)  2
Urinary incontinence * 1  1/380 (0.26%)  1
Urinary retention * 1  1/380 (0.26%)  1
Renal failure * 1  1/380 (0.26%)  1
Renal impairment * 1  1/380 (0.26%)  1
Renal artery stenosis * 1  1/380 (0.26%)  2
Nephrolithiasis * 1  1/380 (0.26%)  1
Reproductive system and breast disorders   
Benign prostatic hyperplasia * 1  2/380 (0.53%)  2
Prostatitis * 1  1/380 (0.26%)  1
Vaginal prolapse * 1  1/380 (0.26%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary oedema * 1  2/380 (0.53%)  2
Respiratory failure * 1  2/380 (0.53%)  2
Pulmonary embolism * 1  1/380 (0.26%)  1
Sleep apnoea syndrome * 1  1/380 (0.26%)  2
Pneumonia aspiration * 1  1/380 (0.26%)  1
Pulmonary necrosis * 1  1/380 (0.26%)  1
Skin and subcutaneous tissue disorders   
Decubitus ulcer * 1  2/380 (0.53%)  2
Dermatitis * 1  1/380 (0.26%)  1
Surgical and medical procedures   
Hip arthroplasty * 1  2/380 (0.53%)  3
Ankle operation * 1  1/380 (0.26%)  1
Knee arthroplasty * 1  1/380 (0.26%)  1
Cataract operation * 1  2/380 (0.53%)  2
Cholecystectomy * 1  2/380 (0.53%)  2
Colostomy closure * 1  1/380 (0.26%)  1
Transurethral prostatectomy * 1  1/380 (0.26%)  1
Deep brain stimulation * 1  1/380 (0.26%)  1
Lung lobectomy * 1  1/380 (0.26%)  1
Coronary artery bypass * 1  1/380 (0.26%)  1
Vascular disorders   
Cardiovascular insufficiency * 1  2/380 (0.53%)  2
Orthostatic hypotension * 1  2/380 (0.53%)  2
Hypotension * 1  1/380 (0.26%)  1
Deep vein thrombosis * 1  2/380 (0.53%)  2
Thrombophlebitis * 1  1/380 (0.26%)  1
Aortic aneurysm * 1  2/380 (0.53%)  2
Femoral arterial stenosis * 1  1/380 (0.26%)  1
Lymphocele * 1  1/380 (0.26%)  1
Hypertension * 1  1/380 (0.26%)  1
Aortic stenosis * 1  1/380 (0.26%)  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   323/380 (85.00%)    
Gastrointestinal disorders   
Nausea * 1  72/380 (18.95%)  115
Vomiting * 1  25/380 (6.58%)  30
Constipation * 1  34/380 (8.95%)  36
Diarrhoea * 1  20/380 (5.26%)  21
General disorders   
Application site reaction * 1  45/380 (11.84%)  54
Application site pruritus * 1  27/380 (7.11%)  32
Application site erythema * 1  26/380 (6.84%)  27
Oedema peripheral * 1  71/380 (18.68%)  93
Fatigue * 1  26/380 (6.84%)  30
Infections and infestations   
Urinary tract infection * 1  29/380 (7.63%)  41
Nasopharyngitis * 1  24/380 (6.32%)  33
Influenza * 1  20/380 (5.26%)  22
Injury, poisoning and procedural complications   
Fall * 1  43/380 (11.32%)  81
Investigations   
Weight increased * 1  19/380 (5.00%)  20
Musculoskeletal and connective tissue disorders   
Back pain * 1  57/380 (15.00%)  78
Pain in extremity * 1  27/380 (7.11%)  36
Arthralgia * 1  36/380 (9.47%)  48
Osteoarthritis * 1  19/380 (5.00%)  21
Nervous system disorders   
Somnolence * 1  146/380 (38.42%)  234
Dizziness * 1  51/380 (13.42%)  62
Headache * 1  29/380 (7.63%)  32
Parkinson's disease * 1  23/380 (6.05%)  35
Psychiatric disorders   
Insomnia * 1  48/380 (12.63%)  57
Depression * 1  38/380 (10.00%)  45
Hallucination * 1  21/380 (5.53%)  32
Respiratory, thoracic and mediastinal disorders   
Cough * 1  27/380 (7.11%)  31
Vascular disorders   
Hypertension * 1  41/380 (10.79%)  44
*
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: NCT00599196    
Other Study ID Numbers: SP0716
SP513OL ( Other Identifier: UCB )
First Submitted: December 24, 2007
First Posted: January 23, 2008
Results First Submitted: December 11, 2009
Results First Posted: January 18, 2010
Last Update Posted: October 2, 2014