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

• 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: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Tracking Information

• First Submitted Date: May 14, 2007
• First Posted Date: May 16, 2007
• Results First Submitted Date: February 25, 2010
• Results First Posted Date: April 12, 2010
• Last Update Posted Date: June 22, 2015
• Study Start Date: May 2007
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 29, 2010)

• Change in Early Morning UPDRS Part III Score [ Time Frame: From baseline to end of maintenance (after 4 weeks maintenance) ]
  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.
• Change in Parkinson's Disease Sleep Scale (PDSS) [ Time Frame: From baseline to end of maintenance (after 4 weeks maintenance) ]
  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.

• Original Primary Outcome Measures (submitted: May 15, 2007): Efficacy [ Time Frame: 4 months ]

Current Secondary Outcome Measures (submitted: March 29, 2010)

• Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) [ Time Frame: From baseline to end of maintenance (after 4 weeks maintenance) ]
  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.
• Change in Number of Nocturias [ Time Frame: From baseline to end of maintenance (after 4 weeks maintenance) ]
  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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine
• Official Title: 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
• 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.

Detailed Description

The objective of this trial is to assess the effects of 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.

After a Screening Period of up to 28 days subjects will be hospitalized for two nights. After the second overnight stay, subjects will be randomly assigned either to rotigotine patch or placebo patch. Afterwards patients will be titrated to their optimal dose. After subjects have reached their optimal dose (or the highest dose) they will be maintained on this dose for a certain period. At the end of maintenance the subjects will be hospitalized for two nights. Afterwards the doses will be continuously decreased.

Efficacy will be assessed by application of sleep quality scores, motor examination scores, and scores to evaluate non-motor symptoms of Parkinsons. Safety assessments include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Parkinson's Disease

Intervention

• Drug: Rotigotine

  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

  Other Name: Neupro
• Other: Placebo
  Placebo transdermal patches

Study Arms

• Experimental: Rotigotine
  Rotigotine transdermal patch
  Intervention: Drug: Rotigotine
• Placebo Comparator: Placebo
  Placebo transdermal patch
  Intervention: Other: Placebo

Publications *

• 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.
• Kassubek 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.
• Swick 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.
• Trenkwalder 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 18, 2009): 287
• Original Estimated Enrollment (submitted: May 15, 2007): 336
• Actual Study Completion Date: March 2009
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Early and advanced Idiopathic Parkinson Disease with early morning motor impairment

Exclusion Criteria:

• Atypical Parkinsonian syndromes

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Finland, Germany, Hungary, Italy, New Zealand, Poland, South Africa, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT00474058
• Other Study ID Numbers: SP0889; EudraCT No.: 2006-006752-35 ( Other Identifier: EudraCT )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: UCB Pharma
• Original Responsible Party: Not Provided
• Current Study Sponsor: UCB Pharma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

• PRS Account: UCB Pharma
• Verification Date: May 2015