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Trial record 1 of 1 for:    NCT00505687
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An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00505687
Recruitment Status : Completed
First Posted : July 23, 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 Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Parkinson's Disease
Intervention Drug: Rotigotine
Enrollment 186
Recruitment Details An Open-Label Extension Trial to Assess the Safety and Tolerability of Long-term Treatment of Rotigotine in Subjects with Idiopathic Parkinson's Disease in 26 locations from February 2005 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 186
Completed 91
Not Completed 95
Reason Not Completed
Important protocol violation             2
Lack of Efficacy             15
Adverse Event             48
Subject withdrew consent             15
Lost to Follow-up             1
Other: Underwent Implantation Of DBS             1
Other: Scheduled DBS Surgery             1
Other: Prolonged Hospitalization             1
Other: Patches Would Not Stick D/T Sweat             1
Other: Neupro Given In Hospital             1
Other: Disease Progression             1
Other: As Per Sponsor             8
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 186
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 186 participants
<=18 years
0
   0.0%
Between 18 and 65 years
94
  50.5%
>=65 years
92
  49.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 186 participants
62.5  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 186 participants
Female
60
  32.3%
Male
126
  67.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 186 participants
United States 80
Spain 9
Austria 4
South Africa 22
Israel 20
Germany 22
United Kingdom 20
Italy 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 four years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 186 subjects who entered the study, 186 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 186
Measure Type: Number
Unit of Measure: Subjects
170
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 four years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 186 subjects who entered the study, 186 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 186
Measure Type: Number
Unit of Measure: Subjects
48
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 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 186 subjects who entered the study, 186 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 186
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Visit 6 (post year 1) (n=164) 9.3  (5.6)
Visit 10 (post year 2) (n=164) 10.0  (5.9)
Visit 14 (post year 3) (n=164) 10.3  (6.1)
End of Treatment (n=182) 10.1  (5.9)
Time Frame up to four 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   45/186 (24.19%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/186 (0.54%)  1
Cardiac disorders   
Angina pectoris * 1  1/186 (0.54%)  1
Myocardial infarction * 1  1/186 (0.54%)  1
Acute myocardial infarction * 1  1/186 (0.54%)  1
Coronary artery stenosis * 1  1/186 (0.54%)  1
Coronary artery occlusion * 1  1/186 (0.54%)  1
Atrial fibrillation * 1  1/186 (0.54%)  1
Gastrointestinal disorders   
Constipation * 1  1/186 (0.54%)  1
Pancreatitis * 1  1/186 (0.54%)  1
Gastritis * 1  1/186 (0.54%)  2
Intestinal obstruction * 1  1/186 (0.54%)  1
General disorders   
Asthenia * 1  1/186 (0.54%)  1
Pyrexia * 1  1/186 (0.54%)  1
Chest pain * 1  1/186 (0.54%)  1
Hepatobiliary disorders   
Cholecystitis * 1  1/186 (0.54%)  1
Cholelithiasis * 1  1/186 (0.54%)  1
Infections and infestations   
Cellulitis * 1  2/186 (1.08%)  3
Septic shock * 1  1/186 (0.54%)  1
Urosepsis * 1  1/186 (0.54%)  1
Pneumonia * 1  1/186 (0.54%)  2
Urinary tract infection * 1  1/186 (0.54%)  1
Injury, poisoning and procedural complications   
Fall * 1  2/186 (1.08%)  2
Femoral neck fracture * 1  1/186 (0.54%)  1
Hip fracture * 1  1/186 (0.54%)  1
Muscle strain * 1  1/186 (0.54%)  1
Post procedural haematoma * 1  1/186 (0.54%)  1
Lumbar vertebral fracture * 1  1/186 (0.54%)  1
Brain contusion * 1  1/186 (0.54%)  1
Humerus fracture * 1  1/186 (0.54%)  1
Musculoskeletal and connective tissue disorders   
Osteoarthritis * 1  3/186 (1.61%)  4
Arthralgia * 1  2/186 (1.08%)  2
Toe deformity * 1  1/186 (0.54%)  1
Fracture nonunion * 1  1/186 (0.54%)  2
Arthritis * 1  1/186 (0.54%)  1
Intervertebral disc protrusion * 1  1/186 (0.54%)  1
Tendonitis * 1  1/186 (0.54%)  1
Bursitis * 1  1/186 (0.54%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Carcinoid tumour of the small bowel * 1  1/186 (0.54%)  1
Metastatic neoplasm * 1  1/186 (0.54%)  1
Malignant fibrous histiocytoma * 1  1/186 (0.54%)  1
Colon cancer * 1  1/186 (0.54%)  2
Nervous system disorders   
Parkinson's disease * 1  3/186 (1.61%)  3
Parkinsonism * 1  2/186 (1.08%)  3
Syncope * 1  2/186 (1.08%)  2
Hypokinesia * 1  1/186 (0.54%)  1
Dyskinesia * 1  1/186 (0.54%)  1
Cerebrovascular accident * 1  1/186 (0.54%)  1
Hydrocephalus * 1  1/186 (0.54%)  1
Lumbar radiculopathy * 1  1/186 (0.54%)  1
Peroneal nerve palsy * 1  1/186 (0.54%)  1
Tremor * 1  1/186 (0.54%)  1
Balance disorder * 1  1/186 (0.54%)  1
Psychiatric disorders   
Abnormal behaviour * 1  1/186 (0.54%)  1
Depression * 1  1/186 (0.54%)  1
Completed suicide * 1  1/186 (0.54%)  1
Renal and urinary disorders   
Urinary retention * 1  1/186 (0.54%)  1
Pollakiuria * 1  1/186 (0.54%)  1
Urge incontinence * 1  1/186 (0.54%)  1
Renal failure * 1  1/186 (0.54%)  1
Nephrolithiasis * 1  1/186 (0.54%)  1
Renal colic * 1  1/186 (0.54%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism * 1  1/186 (0.54%)  1
Pleural effusion * 1  1/186 (0.54%)  1
Skin and subcutaneous tissue disorders   
Urticaria * 1  1/186 (0.54%)  1
Surgical and medical procedures   
Rehabilitation therapy * 1  1/186 (0.54%)  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   136/186 (73.12%)    
Gastrointestinal disorders   
Nausea * 1  21/186 (11.29%)  27
Constipation * 1  12/186 (6.45%)  14
General disorders   
Oedema peripheral * 1  36/186 (19.35%)  45
Application site erythema * 1  24/186 (12.90%)  26
Application site pruritus * 1  16/186 (8.60%)  17
Fatigue * 1  10/186 (5.38%)  11
Injury, poisoning and procedural complications   
Fall * 1  29/186 (15.59%)  47
Musculoskeletal and connective tissue disorders   
Back pain * 1  21/186 (11.29%)  24
Pain in extremity * 1  12/186 (6.45%)  14
Arthralgia * 1  14/186 (7.53%)  16
Nervous system disorders   
Somnolence * 1  52/186 (27.96%)  58
Dizziness * 1  18/186 (9.68%)  19
Parkinson's disease * 1  10/186 (5.38%)  13
Psychiatric disorders   
Insomnia * 1  24/186 (12.90%)  25
Depression * 1  19/186 (10.22%)  20
Anxiety * 1  16/186 (8.60%)  20
Hallucination * 1  11/186 (5.91%)  13
Abnormal dreams * 1  11/186 (5.91%)  11
Sleep disorder * 1  10/186 (5.38%)  10
Vascular disorders   
Hypertension * 1  11/186 (5.91%)  11
*
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: NCT00505687    
Other Study ID Numbers: SP0833
2004-002641-12 ( EudraCT Number )
First Submitted: July 20, 2007
First Posted: July 23, 2007
Results First Submitted: December 8, 2009
Results First Posted: January 12, 2010
Last Update Posted: October 2, 2014