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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, Inc.
ClinicalTrials.gov Identifier:
NCT00464737
First received: April 23, 2007
Last updated: May 25, 2012
Last verified: September 2010
History of Changes
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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  Baseline Characteristics
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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 ]
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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 ]
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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 ]
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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 ]
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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 ]
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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 ]
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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 ]
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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 ]
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9.  Secondary:   Number of Subjects Using Rescue Medication and Alcohol During the 12-week Treatment Phase   [ Time Frame: 12-week Treatment Phase ]
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10.  Secondary:   Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12   [ Time Frame: End of the Maintenance Phase/Week 12 ]
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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 ]
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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 ]
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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 ]
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14.  Secondary:   Number of Subjects With Presence of Impulse Control Disorders   [ Time Frame: 12-week Treatment Phase ]
  Show Outcome Measure 14


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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.  


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: 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