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Trial record 1 of 1 for:    NCT00594165
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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. (SP512OL)

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: NCT00594165
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : February 25, 2010
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Early-Stage Parkinson's Disease
Intervention Drug: Rotigotine
Enrollment 217
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 June 2002 to November 2008
Pre-assignment Details Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.
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 217
Completed 0 [1]
Not Completed 217
Reason Not Completed
Major protocol violation             1
Lack of Efficacy             12
Adverse Event             52
Unsatisfactory compliance of subject             6
Subject withdrew consent             27
Study ended per sponsor             102
Lost to Follow-up             4
Other: PI discretion             5
Other: Subject moving             3
Other: Brain surgery controlled symptoms             1
Other: House bound; can't get to clinic             1
Other: Subject enrolled in other trial             1
Other: Site terminated participation             2
[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 216
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 216 participants
<=18 years
0
   0.0%
Between 18 and 65 years
119
  55.1%
>=65 years
97
  44.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 216 participants
63.2  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 216 participants
Female
69
  31.9%
Male
147
  68.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 216 participants
United States 186
Canada 30
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 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.
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 216
Measure Type: Number
Unit of Measure: Subjects
214
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 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.
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 216
Measure Type: Number
Unit of Measure: subjects
52
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 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set. 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 216
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Visit 9 (end of year 1) (n=209) 7.3  (4.4)
Visit 13 (end of year 2) (n=209) 7.9  (4.9)
Visit 17 (end of year 3) (n=209) 8.2  (5.2)
Visit 21 (end of year 4) (n=209) 8.4  (5.0)
Visit 25 (end of year 5) (n=209) 8.8  (5.0)
Visit 29 (end of year 6) (n=209) 8.5  (5.0)
End of Treatment (n=216) 9.0  (5.4)
Time Frame Up to 7 years
Adverse Event Reporting Description Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set. Adverse event terms may appear in both summaries given that the same adverse event term may be reported for different subjects as either serious or non-serious.
 
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   102/216 (47.22%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/216 (0.46%)  2
Cardiac disorders   
Myocardial infarction * 1  6/216 (2.78%)  6
Angina pectoris * 1  1/216 (0.46%)  1
Angina unstable * 1  1/216 (0.46%)  1
Coronary artery disease * 1  3/216 (1.39%)  3
Coronary artery occlusion * 1  2/216 (0.93%)  2
Arteriosclerosis coronary artery * 1  1/216 (0.46%)  1
Arrhythmia * 1  3/216 (1.39%)  3
Cardiac failure congestive * 1  2/216 (0.93%)  2
Atrioventricular block third degree * 1  1/216 (0.46%)  1
Atrioventricular block second degree * 1  1/216 (0.46%)  1
Atrial fibrillation * 1  1/216 (0.46%)  1
Sick sinus syndrome * 1  1/216 (0.46%)  1
Ventricular tachycardia * 1  1/216 (0.46%)  2
Gastrointestinal disorders   
Lower gastrointestinal haemmorrhage * 2  2/216 (0.93%)  2
Gastrointestinal haemorrhage * 2  2/216 (0.93%)  4
Abdominal pain * 2  2/216 (0.93%)  2
Abdominal pain upper * 2  1/216 (0.46%)  1
Inguinal hernia * 2  2/216 (0.93%)  2
Abdominal strangulated hernia * 2  1/216 (0.46%)  1
Diarrhoea * 2  1/216 (0.46%)  1
Constipation * 2  1/216 (0.46%)  1
Faecal incontinence * 2  1/216 (0.46%)  1
Umbilical hernia * 2  1/216 (0.46%)  1
Small intestinal obstruction * 2  1/216 (0.46%)  1
Erosive oesophagitis * 2  1/216 (0.46%)  1
Pancreatitis * 2  1/216 (0.46%)  1
General disorders   
Chest pain * 2  6/216 (2.78%)  7
Asthenia * 2  2/216 (0.93%)  2
Oedema peripheral * 2  2/216 (0.93%)  2
Pyrexia * 2  1/216 (0.46%)  1
Application site reaction * 2  1/216 (0.46%)  1
Hepatobiliary disorders   
Cholangitis * 2  1/216 (0.46%)  1
Cholecystitis * 2  1/216 (0.46%)  1
Infections and infestations   
Pneumonia * 2  5/216 (2.31%)  8
Diverticulitis * 2  1/216 (0.46%)  1
Gastroenteritis * 2  1/216 (0.46%)  1
Appendicitis * 2  1/216 (0.46%)  1
Urinary tract infection * 2  3/216 (1.39%)  3
Infection * 2  2/216 (0.93%)  3
Localised infection * 2  1/216 (0.46%)  1
Wound infection * 2  1/216 (0.46%)  1
Osteomyelitis * 2  1/216 (0.46%)  1
Endocarditis * 2  1/216 (0.46%)  1
Staphylococcal bacteraemia * 2  1/216 (0.46%)  1
Staphylococcal infection * 2  1/216 (0.46%)  1
Cellulitis * 2  1/216 (0.46%)  1
Sepsis * 2  1/216 (0.46%)  1
Injury, poisoning and procedural complications   
Hip fracture * 2  5/216 (2.31%)  6
Femoral neck fracture * 2  1/216 (0.46%)  1
Foot fracture * 2  1/216 (0.46%)  1
Fall * 2  3/216 (1.39%)  3
Road traffic accident * 2  1/216 (0.46%)  1
Tendon rupture * 2  3/216 (1.39%)  3
Incision site haematoma * 2  1/216 (0.46%)  1
Procedural pain * 2  1/216 (0.46%)  1
Back injury * 2  1/216 (0.46%)  1
Limb injury * 2  1/216 (0.46%)  1
Lumbar vertebral fracture * 2  1/216 (0.46%)  1
Strernal fracture * 2  1/216 (0.46%)  1
Device dislocation * 2  1/216 (0.46%)  1
Investigations   
Electrocardiogram ST-T change * 2  1/216 (0.46%)  1
Hepatic enzyme increased * 2  1/216 (0.46%)  1
Metabolism and nutrition disorders   
Dehydration * 2  2/216 (0.93%)  2
Hypercalcaemia * 2  1/216 (0.46%)  1
Hypoglycaemia * 2  1/216 (0.46%)  1
Musculoskeletal and connective tissue disorders   
Spinal column stenosis * 2  4/216 (1.85%)  4
Lumbar spinal stenosis * 2  3/216 (1.39%)  3
Scoliosis * 2  1/216 (0.46%)  1
Musculoskeletal chest pain * 2  3/216 (1.39%)  3
Pain in extremity * 2  2/216 (0.93%)  2
Back pain * 2  2/216 (0.93%)  2
Musculoskeletal pain * 2  1/216 (0.46%)  1
Osteoarthritis * 2  5/216 (2.31%)  7
Spinal osteoarthritis * 2  1/216 (0.46%)  1
Arthralgia * 2  3/216 (1.39%)  3
Muscular weakness * 2  2/216 (0.93%)  2
Groin pain * 2  1/216 (0.46%)  1
Arthritis * 2  1/216 (0.46%)  3
Osteonecrosis * 2  1/216 (0.46%)  1
Acquired claw toe * 2  1/216 (0.46%)  1
Intervertebral disc protrusion * 2  1/216 (0.46%)  1
Rotator cuff syndrome * 2  1/216 (0.46%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Prostate cancer * 2  3/216 (1.39%)  3
Bile duct cancer * 2  1/216 (0.46%)  1
Ovarian epithelial cancer * 2  1/216 (0.46%)  1
Uterine leiomyoma * 2  1/216 (0.46%)  1
Endometrial cancer * 2  1/216 (0.46%)  1
Renal cell carcinoma stage unspecified * 2  1/216 (0.46%)  1
Salivary gland neoplasm * 2  1/216 (0.46%)  1
Nervous system disorders   
Parkinson's disease * 2  5/216 (2.31%)  7
Parkinsonism * 2  1/216 (0.46%)  1
Syncope * 2  4/216 (1.85%)  5
Depressed level of consciousness * 2  1/216 (0.46%)  1
Somnolence * 2  1/216 (0.46%)  1
Tremor * 2  2/216 (0.93%)  2
Carotid artery occulusion * 2  1/216 (0.46%)  1
Cerebrovascular accident * 2  1/216 (0.46%)  1
Dyskinesia * 2  1/216 (0.46%)  1
Hypoaesthesia * 2  1/216 (0.46%)  1
Presyncope * 2  1/216 (0.46%)  1
Nerve root compression * 2  1/216 (0.46%)  1
Psychiatric disorders   
Hallucination * 2  3/216 (1.39%)  3
Hallucination, visual * 2  1/216 (0.46%)  1
Sleep attacks * 2  2/216 (0.93%)  3
Suicidal ideation * 2  1/216 (0.46%)  1
Suicide attempt * 2  1/216 (0.46%)  1
Abnormal behaviour * 2  1/216 (0.46%)  1
Confusional state * 2  1/216 (0.46%)  1
Renal and urinary disorders   
Urinary retention * 2  2/216 (0.93%)  2
Nephrolithiasis * 2  1/216 (0.46%)  1
Reproductive system and breast disorders   
Ovarian cyst * 2  1/216 (0.46%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory distress * 2  2/216 (0.93%)  2
Respiratory failure * 2  1/216 (0.46%)  1
Accute respiratory failure * 2  1/216 (0.46%)  1
Pulmonary embolism * 2  4/216 (1.85%)  4
Obstructuve airways disorder * 2  1/216 (0.46%)  1
Chronic obstructive pulmonary disease * 2  1/216 (0.46%)  1
Pneumonia aspiration * 2  1/216 (0.46%)  1
Epistaxis * 2  1/216 (0.46%)  1
Surgical and medical procedures   
Spinal laminectomy * 2  2/216 (0.93%)  2
Intervertebral disc operation * 2  1/216 (0.46%)  1
Cholecystectomy * 2  1/216 (0.46%)  1
Hip arthroplasty * 2  1/216 (0.46%)  2
Vascular disorders   
Orthostatic hypotension * 2  2/216 (0.93%)  2
Hypotension * 2  1/216 (0.46%)  1
Angiopathy * 2  1/216 (0.46%)  1
Haemorrhage * 2  1/216 (0.46%)  1
Bleeding varicose vein * 2  1/216 (0.46%)  1
Aortic aneurysm rupture * 2  1/216 (0.46%)  1
Deep vein thrombosis * 2  1/216 (0.46%)  1
Hypertension * 2  1/216 (0.46%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
2
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   206/216 (95.37%)    
Blood and lymphatic system disorders   
Anaemia * 1  17/216 (7.87%)  19
Eye disorders   
Cataract * 1  25/216 (11.57%)  39
Gastrointestinal disorders   
Nausea * 1  66/216 (30.56%)  110
Vomiting * 1  26/216 (12.04%)  44
Constipation * 1  37/216 (17.13%)  42
Dyspepsia * 1  19/216 (8.80%)  19
Diarrhoea * 1  17/216 (7.87%)  21
Dry mouth * 1  15/216 (6.94%)  16
General disorders   
Oedema peripheral * 1  79/216 (36.57%)  121
Application site erythema * 1  31/216 (14.35%)  34
Application site pruritus * 1  19/216 (8.80%)  25
Application site irritation * 1  14/216 (6.48%)  14
Fatigue * 1  24/216 (11.11%)  27
Infections and infestations   
Upper respiratory tract infection * 1  33/216 (15.28%)  49
Nasopharyngitis * 1  25/216 (11.57%)  30
Sinusitis * 1  17/216 (7.87%)  21
Urinary tract infection * 1  33/216 (15.28%)  56
Influenza * 1  17/216 (7.87%)  18
Injury, poisoning and procedural complications   
Fall * 1  69/216 (31.94%)  142
Excoriation * 1  12/216 (5.56%)  14
Contusion * 1  15/216 (6.94%)  18
Skin laceration * 1  15/216 (6.94%)  20
Procedural pain * 1  14/216 (6.48%)  16
Investigations   
Weight decreased * 1  14/216 (6.48%)  16
Blood cholesterol increased * 1  11/216 (5.09%)  11
Musculoskeletal and connective tissue disorders   
Back pain * 1  53/216 (24.54%)  69
Pain in extremity * 1  40/216 (18.52%)  63
Neck pain * 1  12/216 (5.56%)  12
Arthralgia * 1  51/216 (23.61%)  82
Joint swelling * 1  15/216 (6.94%)  16
Muscle spasms * 1  21/216 (9.72%)  25
Osteoarthritis * 1  12/216 (5.56%)  16
Muscular weakness * 1  10/216 (4.63%)  12
Musculoskeletal pain * 1  14/216 (6.48%)  17
Nervous system disorders   
Somnolence * 1  116/216 (53.70%)  198
Dizziness * 1  58/216 (26.85%)  80
Paraesthesia * 1  16/216 (7.41%)  23
Hypoaesthesia * 1  14/216 (6.48%)  21
Headache * 1  21/216 (9.72%)  32
Tremor * 1  19/216 (8.80%)  22
Memory impairment * 1  14/216 (6.48%)  14
Balance disorder * 1  14/216 (6.48%)  16
Dyskinesia * 1  12/216 (5.56%)  13
Parkinson's disease * 1  12/216 (5.56%)  12
Psychiatric disorders   
Insomnia * 1  47/216 (21.76%)  55
Depression * 1  38/216 (17.59%)  45
Anxiety * 1  24/216 (11.11%)  28
Hallucination * 1  20/216 (9.26%)  28
Confusional state * 1  17/216 (7.87%)  19
Sleep disorder * 1  14/216 (6.48%)  16
Abnormal dreams * 1  13/216 (6.02%)  16
Obsessive-compulsive disorder * 1  12/216 (5.56%)  14
Renal and urinary disorders   
Micturition urgency * 1  14/216 (6.48%)  14
Urinary incontinence * 1  12/216 (5.56%)  14
Reproductive system and breast disorders   
Erectile dysfunction * 1  19/216 (8.80%)  20
Respiratory, thoracic and mediastinal disorders   
Cough * 1  17/216 (7.87%)  29
Dyspnoea * 1  13/216 (6.02%)  13
Pharyngolaryngeal pain * 1  12/216 (5.56%)  15
Skin and subcutaneous tissue disorders   
Rash * 1  15/216 (6.94%)  17
Vascular disorders   
Hypertension * 1  27/216 (12.50%)  27
Orthostatic hypotension * 1  12/216 (5.56%)  14
*
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: NCT00594165    
Other Study ID Numbers: SP0702
SP512OL
First Submitted: December 24, 2007
First Posted: January 15, 2008
Results First Submitted: November 6, 2009
Results First Posted: February 25, 2010
Last Update Posted: October 2, 2014