Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01646268
First received: July 18, 2012
Last updated: July 14, 2015
Last verified: July 2015
Results First Received: May 20, 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

  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
The SP0914 study began recruitment in July 2012 and concluded in May 2014. All subjects were recruited in China.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Participant Flow and Demographics data is taken from the Randomized Set (RS). The RS includes all subjects that were randomized.

Reporting Groups
  Description
Rotigotine

Rotigotine, daily doses, treatment group

Rotigotine: Transdermal Patch

Content:

2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)

For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.

Placebo

Placebo, daily doses, placebo group

Placebo Patch: Transdermal Patch

Size:

10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2

Subjects randomized to placebo will receive matching placebo patches.


Participant Flow:   Overall Study
    Rotigotine     Placebo  
STARTED     124     123  
COMPLETED     113     107  
NOT COMPLETED     11     16  
Adverse Event                 6                 7  
Lack of Efficacy                 1                 3  
Protocol Violation                 0                 1  
Withdrawal by Subject                 2                 5  
Unknown                 2                 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 Demographics data is taken from the Randomized Set (RS). The RS includes all subjects that were randomized.

Reporting Groups
  Description
Rotigotine

Rotigotine, daily doses, treatment group

Rotigotine: Transdermal Patch

Content:

2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)

For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.

Placebo

Placebo, daily doses, placebo group

Placebo Patch: Transdermal Patch

Size:

10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2

Subjects randomized to placebo will receive matching placebo patches.

Total Total of all reporting groups

Baseline Measures
    Rotigotine     Placebo     Total  
Number of Participants  
[units: participants]
  124     123     247  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     88     82     170  
>=65 years     36     41     77  
Age  
[units: years]
Mean (Standard Deviation)
  59.1  (10.3)     59.7  (10.1)     59.4  (10.2)  
Gender  
[units: participants]
     
Female     50     47     97  
Male     74     76     150  
Region of Enrollment  
[units: participants]
     
China     124     123     247  
Weight  
[units: kilograms]
Mean (Standard Deviation)
  63.2  (10.5)     64.0  (9.9)     63.6  (10.2)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in the Sum of the Score From the Activities of Daily Living (ADL) Scale and Motor Examination in the Unified Parkinson's Disease Rating Scale (UPDRS) (Parts II+III, a UPDRS Subtotal) From Baseline to the End of Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24) ]

2.  Secondary:   Response to Therapy, Defined as ≥20 % Decrease in the Sum of Scores From Activities of Daily Living (ADL) & Motor Examination in Unified Parkinson's Disease Rating Scale (UPDRS Parts II+III, a UPDRS Subtotal) From Baseline to End of Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24) ]

3.  Secondary:   Change in Unified Parkinson's Disease Rating Scale [UPDRS Part II (ADL)] From Baseline to the End of the Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24) ]

4.  Secondary:   Change in Unified Parkinson’s Disease Rating Scale [UPDRS Part III (Motor Examination)] From Baseline to the End of the Double-blind Maintenance Period   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24) ]


  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 Clinical Trial Call Center
phone: +1 844-599-2279



Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01646268     History of Changes
Other Study ID Numbers: SP0914
Study First Received: July 18, 2012
Results First Received: May 20, 2015
Last Updated: July 14, 2015
Health Authority: China: Food and Drug Administration