The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults. (SP888)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00464737
First received: April 23, 2007
Last updated: May 25, 2012
Last verified: September 2010
Results First Received: November 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Fibromyalgia Syndrome
Interventions: Drug: Rotigotine
Other: 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 Full Analysis Set (FAS) contains all randomized subjects who received at least 1 dose of trial medication, and had at least 1 post-Baseline Likert pain score. The Per Protocol Set contains all subjects in the FAS who completed at least 2 weeks of the Maintenance Phase and had no major protocol deviations.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant flow is based on the 230 randomized subjects however 1 subject randomized to Rotigotine 4 mg/24 hrs did not receive study medication and was excluded from the Safety Set. Thus 229 subjects are included in summaries of baseline characteristics and adverse events. The excluded subject was a 47-year old female enrolled in the United States

Reporting Groups
  Description
Placebo Placebo
Rotigotine 4 mg Rotigotine 4 mg/24 hrs
Rotigotine 8 mg Rotigotine 8 mg/24 hrs

Participant Flow:   Overall Study
    Placebo     Rotigotine 4 mg     Rotigotine 8 mg  
STARTED     82     74     74  
COMPLETED     50     42     19  
NOT COMPLETED     32     32     55  
Adverse Event                 12                 17                 33  
Lack of Efficacy                 7                 7                 4  
Withdrawal by Subject                 5                 3                 5  
Protocol Violation                 1                 1                 5  
Non-compliance                 0                 1                 1  
Lost to Follow-up                 5                 2                 5  
Other: Subject's schedule doesn't permit                 1                 0                 0  
Other: Subject left town; family illness                 1                 0                 0  
Other: Study demands too great                 0                 1                 0  
Other: Personal family reasons                 0                 0                 1  
Other: Subject's disability per sponsor                 0                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Placebo Placebo
Rotigotine 4 mg Rotigotine 4 mg/24 hrs
Rotigotine 8 mg Rotigotine 8 mg/24 hrs
Total Total of all reporting groups

Baseline Measures
    Placebo     Rotigotine 4 mg     Rotigotine 8 mg     Total  
Number of Participants  
[units: participants]
  82     73     74     229  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     81     73     73     227  
>=65 years     1     0     1     2  
Age  
[units: years]
Mean ± Standard Deviation
  46.4  ± 10.7     47.5  ± 10.3     47.0  ± 11.6     47.0  ± 10.8  
Gender  
[units: participants]
       
Female     76     65     68     209  
Male     6     8     6     20  
Region of Enrollment  
[units: participants]
       
United States     82     73     74     229  



  Outcome Measures
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1.  Primary:   Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)   [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]

2.  Primary:   Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)   [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]

3.  Secondary:   Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase   [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]

4.  Secondary:   Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase   [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]

5.  Secondary:   Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase   [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]

6.  Secondary:   Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase   [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]

7.  Secondary:   Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase   [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]

8.  Secondary:   Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase   [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]

9.  Secondary:   Number of Subjects Using Rescue Medication and Alcohol During the 12-week Treatment Phase   [ Time Frame: 12-week Treatment Phase ]

10.  Secondary:   Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12   [ Time Frame: End of the Maintenance Phase/Week 12 ]

11.  Secondary:   Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase   [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]

12.  Secondary:   Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase   [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]

13.  Secondary:   Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the Last Assessment in the 12-week Treatment Phase   [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]

14.  Secondary:   Number of Subjects With Presence of Impulse Control Disorders   [ Time Frame: 12-week Treatment Phase ]


  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: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493


No publications provided


Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00464737     History of Changes
Other Study ID Numbers: SP888
Study First Received: April 23, 2007
Results First Received: November 23, 2009
Last Updated: May 25, 2012
Health Authority: United States: Food and Drug Administration