Trial record 1 of 1 for:    sp1055
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Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction (ROADMAP)

This study has been terminated.
(The study was stopped due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01536015
First received: February 15, 2012
Last updated: July 7, 2014
Last verified: July 2014
Results First Received: July 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Advanced Parkinson's Disease
Interventions: Drug: Rotigotine
Drug: Placebo

  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 total duration of the study was to be a maximum of 19 weeks for each subject, including the Screening Period (within 50 days prior to Day 1), the Titration Period (up to 3 weeks), the Maintenance Period (up to 7 weeks), and a Safety Follow-Up Visit. The Participant Flow refers to the Randomized Set which includes all randomized subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of approximately 150 subjects were planned to be randomized in a 1:1 ratio to either Rotigotine or Placebo.

Reporting Groups
  Description
Placebo

Placebo patch

Placebo: Frequency: One patch applied every 24 hours

Duration: 10 weeks

Rotigotine

Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.

Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours

Dosage and Frequency: One patch every 24 hours

Duration: 10 weeks


Participant Flow:   Overall Study
    Placebo     Rotigotine  
STARTED     12     13  
COMPLETED     4     3  
NOT COMPLETED     8     10  
Adverse Event                 1                 4  
Lost to Follow-up                 0                 1  
Inclusion Criterion not met                 2                 0  
Study closure                 5                 5  



  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.
The Analysis Population Description refers to the Safety Set (SS) which consists of all randomized subjects who received at least one dose of study medication.

Reporting Groups
  Description
Placebo

Placebo patch

Placebo: Frequency: One patch applied every 24 hours

Duration: 10 weeks

Rotigotine

Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.

Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours

Dosage and Frequency: One patch every 24 hours

Duration: 10 weeks

Total Total of all reporting groups

Baseline Measures
    Placebo     Rotigotine     Total  
Number of Participants  
[units: participants]
  12     13     25  
Age  
[units: years]
Mean ± Standard Deviation
  66.1  ± 8.2     66.7  ± 9.6     66.4  ± 8.8  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     6     11  
>=65 years     7     7     14  
Gender  
[units: participants]
     
Female     4     3     7  
Male     8     10     18  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     4     4  
White     11     8     19  
More than one race     1     1     2  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     12     13     25  
Weight  
[units: kilogram]
Mean ± Standard Deviation
  84.64  ± 14.93     76.67  ± 19.53     80.50  ± 17.58  
Height  
[units: centimeter]
Mean ± Standard Deviation
  171.79  ± 13.65     173.86  ± 10.61     172.87  ± 11.95  
Body Mass Index (BMI)  
[units: kilogram/m^2]
Mean ± Standard Deviation
  28.714  ± 4.167     25.113  ± 4.809     26.842  ± 4.785  



  Outcome Measures
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1.  Primary:   Change in Rotigotine Versus Placebo in the Absolute Time Spent "Off" From Baseline to the End of the 7-week Maintenance Period   [ Time Frame: Baseline to 10 weeks ]

2.  Secondary:   Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III (Motor Examination) in the "on" State From Baseline to the End of the 7-week Maintenance Period   [ Time Frame: Baseline to 10 weeks ]

3.  Secondary:   Change in Predictability of "Off" Time (Using MDS UPDRS Part IV Item 4.5) From Baseline to End of the 7-week Maintenance Period   [ Time Frame: Baseline to 10 weeks ]

4.  Secondary:   Change in Score on Gastrointestinal Neurodegenerative Scale (GIND) From Baseline to the End of the of the 7-week Maintenance Period   [ Time Frame: Baseline to 10 weeks ]

5.  Secondary:   Change in Score on Fatigue Severity Scale (FSS) From Baseline to the End of 7-week Maintenance Period   [ Time Frame: Baseline to 10 weeks ]

6.  Secondary:   Change in Score on Parkinson’s Disease Questionnaire (PDQ8) From Baseline to the End of 7-week Maintenance Period   [ Time Frame: Baseline to 10 weeks ]


  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
No text entered.


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01536015     History of Changes
Other Study ID Numbers: SP1055
Study First Received: February 15, 2012
Results First Received: July 7, 2014
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration