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Trial record 1 of 1 for:    NCT00474058
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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
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE May 14, 2007
First Posted Date  ICMJE May 16, 2007
Results First Submitted Date  ICMJE February 25, 2010
Results First Posted Date  ICMJE April 12, 2010
Last Update Posted Date June 22, 2015
Study Start Date  ICMJE May 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: May 15, 2007)
Efficacy [ Time Frame: 4 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • 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  ICMJE
  • Experimental: Rotigotine
    Rotigotine transdermal patch
    Intervention: Drug: Rotigotine
  • Placebo Comparator: Placebo
    Placebo transdermal patch
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2009)
287
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2007)
336
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Atypical Parkinsonian syndromes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Finland,   Germany,   Hungary,   Italy,   New Zealand,   Poland,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00474058
Other Study ID Numbers  ICMJE SP0889
EudraCT No.: 2006-006752-35 ( Other Identifier: EudraCT )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP