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Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine (RECOVER)

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: NCT00474058
Recruitment Status : Completed
First Posted : May 16, 2007
Results First Posted : April 12, 2010
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: Rotigotine
Other: Placebo
Enrollment 287
Recruitment Details A total of 333 subjects were enrolled in this trial and comprised the Enrolled Set (ES). 287 subjects were randomized and all of them received at least 1 dose of trial medication, so they all belong to the Safety Set (SS). 267 subjects belong to the Full Analysis Set (FAS).
Pre-assignment Details Participant Flow shows all 287 subjects who has been enrolled and randomized. Baseline Characteristics are described for the Full Analysis Set (FAS).
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description Rotigotine transdermal patch Placebo transdermal patch
Period Title: Overall Study
Started 190 97
Completed 166 80
Not Completed 24 17
Reason Not Completed
Adverse Event             11             6
Lack of Efficacy             0             4
Withdrawal by Subject             11             7
Other             2             0
Arm/Group Title Rotigotine Placebo Total
Hide Arm/Group Description Rotigotine transdermal patch Placebo transdermal patch Total of all reporting groups
Overall Number of Baseline Participants 178 89 267
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 89 participants 267 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
87
  48.9%
40
  44.9%
127
  47.6%
>=65 years
91
  51.1%
49
  55.1%
140
  52.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 178 participants 89 participants 267 participants
64.7  (9.4) 64.5  (10.4) 64.6  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 89 participants 267 participants
Female
61
  34.3%
31
  34.8%
92
  34.5%
Male
117
  65.7%
58
  65.2%
175
  65.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 89 participants 267 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.6%
1
   1.1%
2
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   1.1%
1
   1.1%
3
   1.1%
White
164
  92.1%
79
  88.8%
243
  91.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
11
   6.2%
8
   9.0%
19
   7.1%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/ m^2
Number Analyzed 178 participants 89 participants 267 participants
26.676  (4.164) 26.645  (4.569) 26.665  (4.295)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 178 participants 89 participants 267 participants
169.04  (9.11) 170.73  (9.27) 169.60  (9.18)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 178 participants 89 participants 267 participants
76.6  (15.1) 78.0  (16.2) 77.1  (15.5)
1.Primary Outcome
Title Change in Early Morning UPDRS Part III Score
Hide Description The Unified Parkinson´s Disease Rating Scale Part III score is an accepted and validated sumscore of 14 items for the assessment of motor function in Parkinson´s disease. Each of the 14 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.
Time Frame From baseline to end of maintenance (after 4 weeks maintenance)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:
Rotigotine transdermal patch
Placebo transdermal patch
Overall Number of Participants Analyzed 178 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.0  (7.6) -3.9  (7.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine, Placebo
Comments Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments No p-value adjustment was necessary, since a multiple test procedure in a hierarchical sequentially rejective manner for the primary variable was applied.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.55
Confidence Interval 95%
-5.37 to -1.73
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in Parkinson's Disease Sleep Scale (PDSS)
Hide Description The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sumscore of all 15 questions.
Time Frame From baseline to end of maintenance (after 4 weeks maintenance)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:
Rotigotine transdermal patch
Placebo transdermal patch
Overall Number of Participants Analyzed 178 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.9  (7.6) -1.9  (8.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine, Placebo
Comments Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No p-value adjustment was necessary, since a multiple testing in a hierarchical sequentially rejective manner for the primary variable was applied.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.26
Confidence Interval 95%
-6.08 to -2.45
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS)
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.
Time Frame From baseline to end of maintenance (after 4 weeks maintenance)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:
Rotigotine transdermal patch
Placebo transdermal patch
Overall Number of Participants Analyzed 163 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.3  (1.8) -0.9  (2.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine, Placebo
Comments Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0301
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.41
Confidence Interval 95%
-0.79 to -0.04
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Number of Nocturias
Hide Description Nocturia is the need to get up during the night and interrupt sleep in order to urinate. It is a typical nocturnal symptom of Parkinson´s disease. The change from baseline in number of nocturias was used to evaluate improvements in sleep disorders.
Time Frame From baseline to end of maintenance (after 4 weeks maintenance)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:
Rotigotine transdermal patch
Placebo transdermal patch
Overall Number of Participants Analyzed 161 78
Mean (Standard Deviation)
Unit of Measure: nocturias
-0.3  (1.3) -0.2  (1.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine, Placebo
Comments Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8842
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval 95%
-0.29 to 0.25
Estimation Comments [Not Specified]
Time Frame Adverse Events (AEs) were collected up to 22 weeks 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 are randomized and received at least one dose of trial medication.
 
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description Rotigotine transdermal patch Placebo transdermal patch
All-Cause Mortality
Rotigotine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Rotigotine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/191 (5.24%)      5/96 (5.21%)    
Gastrointestinal disorders     
Diarrhoea  1  1/191 (0.52%)  1 0/96 (0.00%)  0
General disorders     
Oedema peripheral  1  0/191 (0.00%)  0 1/96 (1.04%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/191 (0.52%)  1 0/96 (0.00%)  0
Infections and infestations     
Urosepsis  1  1/191 (0.52%)  1 0/96 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture  1  1/191 (0.52%)  2 0/96 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/191 (0.52%)  1 0/96 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Chronic lymphocytic leukaemia  1  0/191 (0.00%)  0 1/96 (1.04%)  1
Basal cell carcinoma  1  0/191 (0.00%)  0 1/96 (1.04%)  1
Nervous system disorders     
Cerebrovascular accident  1  0/191 (0.00%)  0 1/96 (1.04%)  1
Syncope  1  1/191 (0.52%)  1 0/96 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion  1  1/191 (0.52%)  1 0/96 (0.00%)  0
Psychiatric disorders     
Panic attack  1  0/191 (0.00%)  0 1/96 (1.04%)  1
Completed suicide  1  0/191 (0.00%)  0 1/96 (1.04%)  1
Hallucination, visual  1  1/191 (0.52%)  1 0/96 (0.00%)  0
Sleep attacks  1  1/191 (0.52%)  1 0/96 (0.00%)  0
Renal and urinary disorders     
Nephrotic syndrome  1  0/191 (0.00%)  0 1/96 (1.04%)  1
Renal impairment  1  0/191 (0.00%)  0 1/96 (1.04%)  1
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/191 (0.52%)  1 0/96 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonia aspiration  1  0/191 (0.00%)  0 1/96 (1.04%)  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 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   70/191 (36.65%)      21/96 (21.88%)    
Gastrointestinal disorders     
Nausea  1  41/191 (21.47%)  54 9/96 (9.38%)  14
Nervous system disorders     
Dizziness  1  20/191 (10.47%)  27 6/96 (6.25%)  6
Headache  1  13/191 (6.81%)  14 5/96 (5.21%)  5
Dyskinesia  1  15/191 (7.85%)  16 4/96 (4.17%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
During the course of the trial, the manufacturing process for rotigotine was changed. At that time, the expiry date for trial medication was Apr 2009, recruitment for SP889 had to be stopped effective on 17 Nov 2008.
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: +1877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00474058    
Other Study ID Numbers: SP0889
EudraCT No.: 2006-006752-35 ( Other Identifier: EudraCT )
First Submitted: May 14, 2007
First Posted: May 16, 2007
Results First Submitted: February 25, 2010
Results First Posted: April 12, 2010
Last Update Posted: June 22, 2015