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Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients

This study has been completed.
Sponsor:
Collaborator:
UCB Trading (Shanghai) Co. Ltd.
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01646255
First received: July 18, 2012
Last updated: January 29, 2016
Last verified: January 2016
Results First Received: October 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Idiopathic Parkinson's Disease
Interventions: Drug: Rotigotine
Drug: Placebo Patch
Drug: L-dopa

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This multicenter, randomized, double-blind, parallel-group, placebo-controlled study started recruiting in August 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant Flow refers to the Safety Set (SS), consisting of all randomized subjects who received at least 1 dose of study medication.

Reporting Groups
  Description
Placebo Subjects randomized to placebo received matching placebo patches.
Rotigotine Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.

Participant Flow:   Overall Study
    Placebo     Rotigotine  
STARTED     172     174  
COMPLETED     151     160  
NOT COMPLETED     21     14  
Adverse Event                 7                 8  
Lack of Efficacy                 2                 0  
Withdrawal by Subject                 10                 6  
Compliance is not well                 1                 0  
Inclusion Criteria Deviation                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline Characteristics refers to to the Safety Set (SS), consisting of all randomized subjects who received at least 1 dose of study medication.

Reporting Groups
  Description
Placebo Subjects randomized to placebo received matching placebo patches.
Rotigotine Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
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Baseline Measures
    Placebo     Rotigotine     Total Title  
Number of Participants  
[units: participants]
  172     174     346  
Age  
[units: years]
     
<=18 years     0     0     0  
Between 18 and 65 years     96     111     207  
>=65 years     76     63     139  
Age  
[units: years]
Mean (Standard Deviation)
     
mean (standard deviation)     62.8  (9.1)     61.7  (8.8)     62.2  (8.9)  
Gender  
[units: Participants]
     
Female     62     81     143  
Male     110     93     203  
Weight  
[units: kg]
Mean (Standard Deviation)
  61.83  (10.18)     60.38  (10.15)     61.10  (10.18)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12) ]

2.  Secondary:   Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12) ]

3.  Secondary:   Percent Change in Absolute Time Spent “Off” From Baseline to the End of Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12) ]

4.  Secondary:   Percent Change in Relative Time Spent “Off” From Baseline to the End of Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12) ]

5.  Secondary:   Change in Absolute Time Spent “on” From Baseline to the End of Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12) ]

6.  Secondary:   Change in Relative Time Spent “on” From Baseline to the End of Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12) ]

7.  Secondary:   Percent Change in Absolute Time Spent “on” From Baseline to the End of Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12) ]

8.  Secondary:   Percent Change in Relative Time Spent “on” From Baseline to the End of Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12) ]

9.  Secondary:   Change in the Number of “Off” Periods From Baseline to the End of Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12) ]

10.  Secondary:   Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12) ]

11.  Secondary:   Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12) ]

12.  Secondary:   Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12) ]

13.  Secondary:   Change in Unified Parkinson’s Disease Rating Scale (UPDRS Part III Motor Examination) During “on” Periods From Baseline to the End of Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: UCB
phone: +1877 822 ext 9493



Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01646255     History of Changes
Other Study ID Numbers: SP1037
Study First Received: July 18, 2012
Results First Received: October 8, 2015
Last Updated: January 29, 2016
Health Authority: China: Food and Drug Administration