Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine (RECOVER)
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ClinicalTrials.gov Identifier: NCT00474058 |
Recruitment Status :
Completed
First Posted : May 16, 2007
Results First Posted : April 12, 2010
Last Update Posted : June 22, 2015
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Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | Rotigotine | Placebo | Total | |
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Rotigotine transdermal patch | Placebo transdermal patch | Total of all reporting groups | |
Overall Number of Baseline Participants | 178 | 89 | 267 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 178 participants | 89 participants | 267 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
87 48.9%
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40 44.9%
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127 47.6%
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>=65 years |
91 51.1%
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49 55.1%
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140 52.4%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 178 participants | 89 participants | 267 participants | |
Female |
61 34.3%
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31 34.8%
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92 34.5%
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Male |
117 65.7%
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58 65.2%
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175 65.5%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 178 participants | 89 participants | 267 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
1 0.6%
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1 1.1%
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2 0.7%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
2 1.1%
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1 1.1%
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3 1.1%
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White |
164 92.1%
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79 88.8%
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243 91.0%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
11 6.2%
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8 9.0%
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19 7.1%
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Body Mass Index (BMI)
Mean (Standard Deviation) Unit of measure: Kg/ m^2 |
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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 |
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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 |
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Number Analyzed | 178 participants | 89 participants | 267 participants | |
76.6 (15.1) | 78.0 (16.2) | 77.1 (15.5) |
Outcome Measures
Adverse Events
Limitations and Caveats
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.
More Information
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
Name/Title: | UCB Clinical Trial Call Center |
Organization: | UCB |
Phone: | +1877 822 9493 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |