Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine
RECOVER
Phase 3B, Multicenter, Multinational, Double-Blind, Placebo Controlled, 2-Arm Trial to Evaluate the Effect of the 24-Hour Transdermal Delivery of Rotigotine on the Control of Early Morning Motor Function, Sleep Quality, Nocturnal Symptoms, and Non-Motor Symptoms in Subjects With Idiopathic Parkinson's Disease
2 other identifiers
interventional
287
11 countries
46
Brief Summary
The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2007
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 14, 2007
CompletedFirst Posted
Study publicly available on registry
May 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
April 12, 2010
CompletedJune 22, 2015
May 1, 2015
1.8 years
May 14, 2007
February 25, 2010
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Early Morning UPDRS Part III Score
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.
From baseline to end of maintenance (after 4 weeks maintenance)
Change in Parkinson's Disease Sleep Scale (PDSS)
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.
From baseline to end of maintenance (after 4 weeks maintenance)
Secondary Outcomes (2)
Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS)
From baseline to end of maintenance (after 4 weeks maintenance)
Change in Number of Nocturias
From baseline to end of maintenance (after 4 weeks maintenance)
Study Arms (2)
Rotigotine
EXPERIMENTALRotigotine transdermal patch
Placebo
PLACEBO COMPARATORPlacebo transdermal patch
Interventions
Rotigotine transdermal patches: 10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h) Optimal dosing: The maximum Rotigotine dose allowed is 16mg/24h
Eligibility Criteria
You may qualify if:
- Early and advanced Idiopathic Parkinson Disease with early morning motor impairment
You may not qualify if:
- Atypical Parkinsonian syndromes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (47)
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Reseda, California, United States
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Ventura, California, United States
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St. Petersburg, Florida, 33701, United States
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Salisbury, North Carolina, 28144, United States
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Winston_Salem, North Carolina, United States
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Warwick, Rhode Island, United States
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Houston, Texas, United States
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Concord, New South Wales, Australia
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Adelaide, South Australia, Australia
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Fitzroy, Australia
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Innsbruck, 6020, Austria
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Hyvinkää, Finland
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Oulu, 90220, Finland
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Berlin, 10713, Germany
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Berlin, 12163, Germany
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Dresden, 01307, Germany
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Kassel, 34128, Germany
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Leipzig, Germany
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Marburg, 35039, Germany
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Naumburg, Germany
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Ulm, 89081, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Nyíregyháza, Hungary
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Zalaegerszeg, Hungary
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Chieti, 66013, Italy
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Milan, Italy
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Torino, Italy
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Christchurch, New Zealand
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Wellington, New Zealand
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Gdansk, Poland
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Krakow, Poland
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Lublin, Poland
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Olsztyn, Poland
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Szczecin, Poland
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Warsaw, Poland
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Cape Town, South Africa
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Capetown, South Africa
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Johannesburg, South Africa
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Pretoria/Gauteng, South Africa
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Tygerberg, South Africa
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Barcelona, 08036, Spain
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Madrid, Spain
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Bristol, United Kingdom
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Lancashire, United Kingdom
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Liverpool, United Kingdom
Unknown Facility
London, United Kingdom
Related Publications (4)
Ghys L, Surmann E, Whitesides J, Boroojerdi B. Effect of rotigotine on sleep and quality of life in Parkinson's disease patients: post hoc analysis of RECOVER patients who were symptomatic at baseline. Expert Opin Pharmacother. 2011 Sep;12(13):1985-98. doi: 10.1517/14656566.2011.604031. Epub 2011 Jul 27.
PMID: 21790503RESULTKassubek J, Chaudhuri KR, Zesiewicz T, Surmann E, Boroojerdi B, Moran K, Ghys L, Trenkwalder C. Rotigotine transdermal system and evaluation of pain in patients with Parkinson's disease: a post hoc analysis of the RECOVER study. BMC Neurol. 2014 Mar 6;14:42. doi: 10.1186/1471-2377-14-42.
PMID: 24602411DERIVEDSwick TJ, Friedman JH, Chaudhuri KR, Surmann E, Boroojerdi B, Moran K, Ghys L, Trenkwalder C. Associations between severity of motor function and nonmotor symptoms in Parkinson's disease: a post hoc analysis of the RECOVER Study. Eur Neurol. 2014;71(3-4):140-7. doi: 10.1159/000355019. Epub 2014 Jan 21.
PMID: 24457253DERIVEDTrenkwalder C, Kies B, Rudzinska M, Fine J, Nikl J, Honczarenko K, Dioszeghy P, Hill D, Anderson T, Myllyla V, Kassubek J, Steiger M, Zucconi M, Tolosa E, Poewe W, Surmann E, Whitesides J, Boroojerdi B, Chaudhuri KR; Recover Study Group. Rotigotine effects on early morning motor function and sleep in Parkinson's disease: a double-blind, randomized, placebo-controlled study (RECOVER). Mov Disord. 2011 Jan;26(1):90-9. doi: 10.1002/mds.23441. Epub 2010 Nov 18.
PMID: 21322021DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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.
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2007
First Posted
May 16, 2007
Study Start
May 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
June 22, 2015
Results First Posted
April 12, 2010
Record last verified: 2015-05