Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00594386
Previous Study | Return to List | Next Study

An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease (SP715)

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: NCT00594386
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : December 18, 2009
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 Parkinson's Disease
Intervention Drug: Rotigotine
Enrollment 258
Recruitment Details A multicenter Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson’s Disease with 41 sites in United States and Canada from August 2002 to December 2008
Pre-assignment Details  
Arm/Group Title Rotigotine
Hide Arm/Group Description Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 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 258
Completed 0 [1]
Not Completed 258
Reason Not Completed
Major protocol violation             2
Lack of Efficacy             12
Adverse Event             68
Unsatisfactory compliance of subject             11
Subject withdrew consent             35
Study ended per sponsor             115
Lost to Follow-up             6
Other: Patient went off patch (hospital)             1
Other: Subject moved to Seattle             1
Other: Subject admitted to nursing home             1
Other: Study terminated per investigator             2
Other: Sponsor closure of study             1
Other: Site terminated participation             1
Other: Patient wants prescription Neupro             1
Other: Loss of drivers license             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 6 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 258
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants
<=18 years
0
   0.0%
Between 18 and 65 years
98
  38.0%
>=65 years
160
  62.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 258 participants
66.4  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants
Female
85
  32.9%
Male
173
  67.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 258 participants
United States 243
Canada 15
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 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 258 subjects who entered the study, 258 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: Year 1, the maximum dose allowed is 6 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 258
Measure Type: Number
Unit of Measure: Subjects
258
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 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 258 subjects who entered the study, 258 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: Year 1, the maximum dose allowed is 6 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 258
Measure Type: Number
Unit of Measure: Subjects
68
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 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (end of year 6), End of Treatment (last study visit or early withdrawal visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 258 subjects who entered the study, 258 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: Year 1, the maximum dose allowed is 6 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 258
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Visit 11 (end of year 1) (n=254) 8.6  (4.9)
Visit 15 (end of year 2) (n=254) 8.9  (4.9)
Visit 19 (end of year 3) (n=254) 9.3  (5.1)
Visit 23 (end of year 4) (n=254) 9.8  (5.2)
Visit 27 (end of year 5) (n=254) 9.7  (5.3)
Visit 31 (end of year 6) (n=254) 10.0  (5.4)
End of Treatment (n=258) 10.0  (5.4)
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 6 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   165/258 (63.95%)    
Blood and lymphatic system disorders   
Iron deficiency anaemia * 1  1/258 (0.39%)  1
Cardiac disorders   
Myocardial infarction * 1  5/258 (1.94%)  5
Acute myocardial infarction * 1  2/258 (0.78%)  2
Acute coronary syndrome * 1  1/258 (0.39%)  2
Angina unstable * 1  1/258 (0.39%)  1
Cardiac failure congestive * 1  7/258 (2.71%)  12
Coronary artery disease * 1  6/258 (2.33%)  6
Coronary artery occlusion * 1  1/258 (0.39%)  1
Atrial fibrillation * 1  2/258 (0.78%)  3
Sick sinus syndrome * 1  1/258 (0.39%)  1
Supraventricular tachycardia * 1  1/258 (0.39%)  1
Cardio-respiratory arrest * 1  2/258 (0.78%)  2
Bradycardia * 1  1/258 (0.39%)  1
Tachycardia * 1  1/258 (0.39%)  1
Cardiac aneurysm * 1  1/258 (0.39%)  1
Atrioventricular block second degree * 1  1/258 (0.39%)  1
Ear and labyrinth disorders   
Vertigo * 1  1/258 (0.39%)  1
Gastrointestinal disorders   
Ileus * 1  3/258 (1.16%)  4
Intestinal obstruction * 1  1/258 (0.39%)  1
Gastrointestinal haemorrhage * 1  2/258 (0.78%)  3
Upper gastrointestinal haemorrhage * 1  1/258 (0.39%)  3
Peritoneal haemorrhage * 1  1/258 (0.39%)  1
Retroperitoneal haematoma * 1  1/258 (0.39%)  1
Constipation * 1  2/258 (0.78%)  2
Erosive oesophagitis * 1  1/258 (0.39%)  1
Oesophageal ulcer * 1  1/258 (0.39%)  1
Abdominal pain upper * 1  1/258 (0.39%)  1
Abdominal pain * 1  1/258 (0.39%)  1
Intestinal haemorrhage * 1  1/258 (0.39%)  1
Dysphagia * 1  1/258 (0.39%)  1
Gastric ulcer * 1  1/258 (0.39%)  1
Enterovesical fistula * 1  1/258 (0.39%)  1
Colitis ischaemic * 1  1/258 (0.39%)  1
Inguinal hernia * 1  1/258 (0.39%)  1
Diarrhoea * 1  1/258 (0.39%)  1
Intestinal ischaemia * 1  1/258 (0.39%)  1
General disorders   
Chest pain * 1  10/258 (3.88%)  11
Pain * 1  1/258 (0.39%)  1
Asthenia * 1  3/258 (1.16%)  3
Malaise * 1  1/258 (0.39%)  1
Implant site pain * 1  1/258 (0.39%)  1
Mechanical complication of implant * 1  1/258 (0.39%)  1
Implant site erosion * 1  1/258 (0.39%)  1
Gait disturbance * 1  2/258 (0.78%)  2
Cardiac death * 1  1/258 (0.39%)  1
Pyrexia * 1  1/258 (0.39%)  1
Hernia * 1  1/258 (0.39%)  1
Oedema peripheral * 1  1/258 (0.39%)  1
Hepatobiliary disorders   
Cholangitis * 1  1/258 (0.39%)  1
Cholecystitis acute * 1  1/258 (0.39%)  1
Jaundice * 1  1/258 (0.39%)  1
Infections and infestations   
Pneumonia * 1  6/258 (2.33%)  8
Bronchitis * 1  3/258 (1.16%)  3
Lobar pneumonia * 1  3/258 (1.16%)  3
Lower respiratory tract infection * 1  1/258 (0.39%)  1
Bronchitis acute * 1  1/258 (0.39%)  2
Cellulitis * 1  7/258 (2.71%)  8
Arthritis bacterial * 1  1/258 (0.39%)  1
Bacterial infection * 1  1/258 (0.39%)  1
Pneumonia bacterial * 1  1/258 (0.39%)  1
Urinary tract infection * 1  8/258 (3.10%)  9
Device related infection * 1  1/258 (0.39%)  1
Localised infection * 1  1/258 (0.39%)  1
Infection * 1  1/258 (0.39%)  1
Catheter related infection * 1  1/258 (0.39%)  1
Incision site abscess * 1  1/258 (0.39%)  1
Postoperative wound infection * 1  1/258 (0.39%)  1
Sepsis * 1  2/258 (0.78%)  2
Septic shock * 1  1/258 (0.39%)  1
Urosepsis * 1  1/258 (0.39%)  1
Gastroenteritis * 1  2/258 (0.78%)  2
Rectal abscess * 1  1/258 (0.39%)  1
Extradural abscess * 1  1/258 (0.39%)  1
Pneumonia klebsiella * 1  1/258 (0.39%)  1
Subcutaneous abscess * 1  1/258 (0.39%)  1
Cellulitis streptococcal * 1  1/258 (0.39%)  1
Mastoiditis * 1  1/258 (0.39%)  1
Staphylococcal infection * 1  1/258 (0.39%)  1
Escherichia sepsis * 1  1/258 (0.39%)  1
Injury, poisoning and procedural complications   
Fall * 1  13/258 (5.04%)  14
Hip fracture * 1  6/258 (2.33%)  6
Femur fracture * 1  1/258 (0.39%)  1
Subdural haematoma * 1  5/258 (1.94%)  5
Concussion * 1  1/258 (0.39%)  1
Upper limb fracture * 1  2/258 (0.78%)  2
Wrist fracture * 1  2/258 (0.78%)  2
Humerus fracture * 1  1/258 (0.39%)  1
Radius fracture * 1  1/258 (0.39%)  1
Ulna fracture * 1  1/258 (0.39%)  1
Meniscus lesion * 1  1/258 (0.39%)  1
Limb injury * 1  1/258 (0.39%)  1
Accidental overdose * 1  2/258 (0.78%)  2
Hepatic trauma * 1  1/258 (0.39%)  1
Pelvic fracture * 1  1/258 (0.39%)  1
Facial bones fracture * 1  1/258 (0.39%)  1
Rib fracture * 1  1/258 (0.39%)  1
Chest injury * 1  1/258 (0.39%)  1
Joint dislocation * 1  1/258 (0.39%)  4
Tendon rupture * 1  1/258 (0.39%)  2
Vascular procedure complication * 1  1/258 (0.39%)  1
Investigations   
Haematocrit decreased * 1  1/258 (0.39%)  1
Haemoglobin decreased * 1  1/258 (0.39%)  1
Metabolism and nutrition disorders   
Dehydration * 1  9/258 (3.49%)  9
Hypovolaemia * 1  1/258 (0.39%)  1
Hyponatraemia * 1  4/258 (1.55%)  4
Hyperglycaemia * 1  1/258 (0.39%)  1
Failure to thrive * 1  1/258 (0.39%)  1
Hypokalaemia * 1  1/258 (0.39%)  1
Lactose intolerance * 1  1/258 (0.39%)  1
Hypoglycaemia * 1  1/258 (0.39%)  1
Hypomagnesaemia * 1  1/258 (0.39%)  1
Musculoskeletal and connective tissue disorders   
Cervical spinal stenosis * 1  4/258 (1.55%)  4
Spinal column stenosis * 1  3/258 (1.16%)  3
Lumbar spinal stenosis * 1  2/258 (0.78%)  2
Back pain * 1  6/258 (2.33%)  6
Pain in extremity * 1  1/258 (0.39%)  1
Osteoarthritis * 1  6/258 (2.33%)  8
Arthralgia * 1  2/258 (0.78%)  3
Loose body in joint * 1  1/258 (0.39%)  1
Joint swelling * 1  1/258 (0.39%)  1
Muscular weakness * 1  3/258 (1.16%)  3
Arthritis * 1  2/258 (0.78%)  3
Intervertebral disc disorder * 1  1/258 (0.39%)  1
Intervertebral disc protrusion * 1  1/258 (0.39%)  1
Rhabdomyolysis * 1  2/258 (0.78%)  2
Groin pain * 1  1/258 (0.39%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Prostate cancer * 1  3/258 (1.16%)  3
Renal cell carcinoma stage unspecified * 1  1/258 (0.39%)  1
Renal cancer metastatic * 1  1/258 (0.39%)  1
Non-Hodgkin's lymphoma * 1  1/258 (0.39%)  1
Malignant melanoma * 1  1/258 (0.39%)  1
Lymphoma * 1  1/258 (0.39%)  1
Carcinoid tumour * 1  1/258 (0.39%)  1
Gastrointestinal tract adenoma * 1  1/258 (0.39%)  1
Hodgkin's disease * 1  1/258 (0.39%)  1
Gastric cancer * 1  1/258 (0.39%)  1
Nervous system disorders   
Parkinson's disease * 1  25/258 (9.69%)  28
Parkinsonian crisis * 1  1/258 (0.39%)  1
Cerebrovascular accident * 1  8/258 (3.10%)  9
Embolic stroke * 1  2/258 (0.78%)  2
Brain stem infarction * 1  1/258 (0.39%)  1
Cerebral haemorrhage * 1  1/258 (0.39%)  1
Syncope * 1  8/258 (3.10%)  9
Syncope vasovagal * 1  1/258 (0.39%)  1
Depressed level of consciousness * 1  1/258 (0.39%)  1
Transient ischaemic attack * 1  4/258 (1.55%)  5
Dyskinesia * 1  3/258 (1.16%)  3
Akinesia * 1  1/258 (0.39%)  1
Dementia * 1  3/258 (1.16%)  3
Tremor * 1  2/258 (0.78%)  2
Metabolic encephalopathy * 1  1/258 (0.39%)  1
Convulsion * 1  1/258 (0.39%)  1
Cervical myelopathy * 1  1/258 (0.39%)  1
Presyncope * 1  1/258 (0.39%)  1
Normal pressure hydrocephalus * 1  1/258 (0.39%)  1
Psychiatric disorders   
Hallucination * 1  8/258 (3.10%)  8
Hallucination, visual * 1  2/258 (0.78%)  2
Mental status changes * 1  3/258 (1.16%)  3
Confusional state * 1  3/258 (1.16%)  3
Sleep attacks * 1  3/258 (1.16%)  3
Agitation * 1  1/258 (0.39%)  1
Anxiety * 1  1/258 (0.39%)  1
Pathological gambling * 1  2/258 (0.78%)  2
Delirium * 1  1/258 (0.39%)  1
Delusion * 1  1/258 (0.39%)  1
Depression * 1  1/258 (0.39%)  1
Mania * 1  1/258 (0.39%)  1
Completed suicide * 1  1/258 (0.39%)  1
Renal and urinary disorders   
Renal failure acute * 1  3/258 (1.16%)  3
Acute prerenal failure * 1  1/258 (0.39%)  1
Renal failure chronic * 1  1/258 (0.39%)  1
Renal failure * 1  1/258 (0.39%)  1
Nephrolithiasis * 1  2/258 (0.78%)  2
Urinary retention * 1  1/258 (0.39%)  1
Nephrosclerosis * 1  1/258 (0.39%)  1
Renal mass * 1  1/258 (0.39%)  1
Urethral obstruction * 1  1/258 (0.39%)  1
Haematuria * 1  1/258 (0.39%)  1
Calculus ureteric * 1  1/258 (0.39%)  1
Reproductive system and breast disorders   
Uterine prolapse * 1  1/258 (0.39%)  1
Rectocele * 1  1/258 (0.39%)  1
Breast mass * 1  1/258 (0.39%)  1
Prostatitis * 1  1/258 (0.39%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia aspiration * 1  6/258 (2.33%)  6
Chronic obstructive pulmonary disease * 1  4/258 (1.55%)  6
Dyspnoea * 1  4/258 (1.55%)  4
Respiratory failure * 1  2/258 (0.78%)  2
Acute respiratory failure * 1  2/258 (0.78%)  2
Atelectasis * 1  1/258 (0.39%)  1
Acute respiratory distress syndrome * 1  1/258 (0.39%)  1
Mediastinal mass * 1  1/258 (0.39%)  1
Hypoxia * 1  1/258 (0.39%)  1
Surgical and medical procedures   
Deep brain stimulation * 1  1/258 (0.39%)  1
Knee arthroplasty * 1  1/258 (0.39%)  1
Intervertebral disc operation * 1  1/258 (0.39%)  1
Vascular disorders   
Hypotension * 1  3/258 (1.16%)  3
Orthostatic hypotension * 1  2/258 (0.78%)  3
Haemorrhage * 1  2/258 (0.78%)  2
Circulatory collapse * 1  2/258 (0.78%)  2
Aortic stenosis * 1  1/258 (0.39%)  1
Deep vein thrombosis * 1  1/258 (0.39%)  2
Arteriosclerosis * 1  1/258 (0.39%)  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   253/258 (98.06%)    
Blood and lymphatic system disorders   
Anaemia * 1  18/258 (6.98%)  19
Eye disorders   
Cataract * 1  24/258 (9.30%)  33
Gastrointestinal disorders   
Constipation * 1  58/258 (22.48%)  66
Gastrooesophageal reflux disease * 1  23/258 (8.91%)  23
Nausea * 1  61/258 (23.64%)  94
Vomiting * 1  29/258 (11.24%)  32
Diarrhoea * 1  25/258 (9.69%)  28
Abdominal pain * 1  13/258 (5.04%)  17
Dyspepsia * 1  13/258 (5.04%)  14
General disorders   
Application site erythema * 1  37/258 (14.34%)  44
Application site pruritus * 1  34/258 (13.18%)  35
Application site reaction * 1  14/258 (5.43%)  16
Oedema peripheral * 1  80/258 (31.01%)  111
Fatigue * 1  22/258 (8.53%)  23
Asthenia * 1  18/258 (6.98%)  20
Infections and infestations   
Upper respiratory tract infection * 1  39/258 (15.12%)  51
Nasopharyngitis * 1  32/258 (12.40%)  41
Urinary tract infection * 1  55/258 (21.32%)  86
Pneumonia * 1  14/258 (5.43%)  15
Cellulitis * 1  18/258 (6.98%)  21
Injury, poisoning and procedural complications   
Fall * 1  100/258 (38.76%)  198
Excoriation * 1  17/258 (6.59%)  26
Contusion * 1  29/258 (11.24%)  54
Skin laceration * 1  23/258 (8.91%)  30
Investigations   
Weight decreased * 1  24/258 (9.30%)  26
Metabolism and nutrition disorders   
Dehydration * 1  15/258 (5.81%)  15
Hypokalaemia * 1  13/258 (5.04%)  14
Musculoskeletal and connective tissue disorders   
Back pain * 1  51/258 (19.77%)  65
Pain in extremity * 1  46/258 (17.83%)  65
Musculoskeletal pain * 1  35/258 (13.57%)  46
Neck pain * 1  17/258 (6.59%)  19
Arthralgia * 1  60/258 (23.26%)  77
Muscle spasms * 1  24/258 (9.30%)  30
Arthritis * 1  17/258 (6.59%)  18
Nervous system disorders   
Somnolence * 1  150/258 (58.14%)  236
Dizziness * 1  61/258 (23.64%)  72
Hypoaesthesia * 1  20/258 (7.75%)  25
Parkinson's disease * 1  20/258 (7.75%)  22
Headache * 1  28/258 (10.85%)  36
Dyskinesia * 1  25/258 (9.69%)  32
Memory impairment * 1  15/258 (5.81%)  15
Balance disorder * 1  13/258 (5.04%)  13
Psychiatric disorders   
Hallucination * 1  54/258 (20.93%)  68
Insomnia * 1  56/258 (21.71%)  66
Depression * 1  46/258 (17.83%)  51
Confusional state * 1  39/258 (15.12%)  44
Anxiety * 1  34/258 (13.18%)  38
Renal and urinary disorders   
Urinary incontinence * 1  28/258 (10.85%)  30
Pollakiuria * 1  17/258 (6.59%)  21
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  29/258 (11.24%)  36
Cough * 1  27/258 (10.47%)  30
Skin and subcutaneous tissue disorders   
Rash * 1  23/258 (8.91%)  26
Vascular disorders   
Hypertension * 1  36/258 (13.95%)  41
*
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: NCT00594386    
Other Study ID Numbers: SP0715
First Submitted: December 24, 2007
First Posted: January 15, 2008
Results First Submitted: November 16, 2009
Results First Posted: December 18, 2009
Last Update Posted: October 2, 2014