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Trial record 1 of 1 for:    NCT00519532
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Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic 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: NCT00519532
Recruitment Status : Terminated (Due to clinical trial supplies shortage)
First Posted : August 22, 2007
Results First Posted : April 2, 2010
Last Update Posted : October 27, 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 84
Recruitment Details A total of 84 subjects belong to the Enrolled Set (ES) and all of them received at least 1 dose of trial medication, so they all belong to the Safety Set (SS). 83 subjects belong to the Full Analysis Set (FAS).
Pre-assignment Details Participant Flow information belong to the Enrolled Set (ES). Baseline Characteristics are described for the Full Analysis Set (FAS).
Arm/Group Title Rotigotine
Hide Arm/Group Description Rotigotine Transdermal Patch
Period Title: Overall Study
Started 84
Completed 66
Not Completed 18
Reason Not Completed
Adverse Event             11
Withdrawal by Subject             5
Lost to Follow-up             2
Arm/Group Title Rotigotine
Hide Arm/Group Description Rotigotine Transdermal Patch
Overall Number of Baseline Participants 83
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants
<=18 years
0
   0.0%
Between 18 and 65 years
34
  41.0%
>=65 years
49
  59.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants
66.2  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants
Female
26
  31.3%
Male
57
  68.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   3.6%
White
71
  85.5%
More than one race
0
   0.0%
Unknown or Not Reported
9
  10.8%
L- Dopa  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 83 participants
Early 10
Advanced 73
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/ m^2
Number Analyzed 83 participants
26.928  (4.219)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 83 participants
170.1  (10.58)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 83 participants
78.3  (16.6)
1.Primary Outcome
Title Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)
Hide Description

The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.

Baseline is defined as first titration visit (T1) of SP915.

Time Frame Baseline (baseline SP915) and week 13 (End of maintenance)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Rotigotine Transdermal Patch
Overall Number of Participants Analyzed 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.8  (9.4)
2.Primary Outcome
Title Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)
Hide Description

The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often.

Baseline is defined as Visit 2 of previous double- blind trial SP889.

Time Frame Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Rotigotine Transdermal Patch
Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.8  (7.8)
3.Secondary Outcome
Title Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)
Hide Description

Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.

Baseline is defined as Visit 2 of previous double- blind trial SP889.

Time Frame Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Rotigotine Transdermal Patch
Overall Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.5  (2.1)
4.Secondary Outcome
Title Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)
Hide Description

The change in number of nocturias was used to evaluate improvements in sleep disorders.

Baseline is defined as Visit 2 of previous double- blind trial SP889.

Time Frame Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Rotigotine Transdermal Patch
Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: Nocturias
-0.4  (1.2)
Time Frame Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Adverse Event Reporting Description Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
 
Arm/Group Title Rotigotine
Hide Arm/Group Description Rotigotine Transdermal Patch
All-Cause Mortality
Rotigotine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Rotigotine
Affected / at Risk (%) # Events
Total   16/84 (19.05%)    
Cardiac disorders   
Atrial fibrillation  1  1/84 (1.19%)  1
Atrioventricular block third degree  1  1/84 (1.19%)  1
Gastrointestinal disorders   
Vomiting  1  1/84 (1.19%)  1
Reflux oesophagitis  1  1/84 (1.19%)  1
Inguinal hernia  1  1/84 (1.19%)  1
General disorders   
Application site vesicles  1  1/84 (1.19%)  1
Chest pain  1  1/84 (1.19%)  1
Death  1  1/84 (1.19%)  1
Infections and infestations   
Osteomyelitis  1  1/84 (1.19%)  1
Injury, poisoning and procedural complications   
Femoral neck fracture  1  3/84 (3.57%)  3
Post procedural haematuria  1  1/84 (1.19%)  1
Investigations   
Eosinophil count increased  1  1/84 (1.19%)  1
Musculoskeletal and connective tissue disorders   
Trigger finger  1  1/84 (1.19%)  1
Osteoarthritis  1  1/84 (1.19%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer  1  1/84 (1.19%)  1
Malignant melanoma  1  1/84 (1.19%)  1
Nervous system disorders   
Syncope vasovagal  1  1/84 (1.19%)  1
Peroneal nerve palsy  1  1/84 (1.19%)  1
Respiratory, thoracic and mediastinal disorders   
Emphysema  1  1/84 (1.19%)  1
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  1/84 (1.19%)  1
Indicates events were collected by 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   55/84 (65.48%)    
Gastrointestinal disorders   
Nausea  1  10/84 (11.90%)  13
Vomiting  1  5/84 (5.95%)  6
Constipation  1  5/84 (5.95%)  6
General disorders   
Application site pruritus  1  8/84 (9.52%)  10
Application site erythema  1  10/84 (11.90%)  12
Application site irritation  1  5/84 (5.95%)  6
Oedema peripheral  1  8/84 (9.52%)  10
Infections and infestations   
Urinary tract infection  1  7/84 (8.33%)  8
Nasopharyngitis  1  5/84 (5.95%)  6
Injury, poisoning and procedural complications   
Fall  1  10/84 (11.90%)  11
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  8/84 (9.52%)  9
Back pain  1  6/84 (7.14%)  10
Arthralgia  1  5/84 (5.95%)  6
Nervous system disorders   
Dyskinesia  1  9/84 (10.71%)  9
Parkinson´s disease  1  8/84 (9.52%)  11
Dizziness  1  9/84 (10.71%)  11
Somnolence  1  11/84 (13.10%)  12
Headache  1  5/84 (5.95%)  11
Psychiatric disorders   
Hallucination  1  11/84 (13.10%)  22
Insomnia  1  7/84 (8.33%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Because the manufacturing process for rotigotine patches was changed, enrollment into SP915 was stopped in April 2008 to ensure sufficient trial medication for all subjects enrolled at that time to complete the trial according to the protocol.
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 is confidential and 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: +18778229493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00519532    
Other Study ID Numbers: SP0915
EudraCT number: 2006-006907-35 ( Other Identifier: EudraCT )
First Submitted: August 21, 2007
First Posted: August 22, 2007
Results First Submitted: March 17, 2010
Results First Posted: April 2, 2010
Last Update Posted: October 27, 2014