Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00401830
First received: November 9, 2006
Last updated: September 19, 2014
Last verified: December 2009
Results First Received: September 22, 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: Lacosamide
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Matching placebo tablet (administered twice daily)
Lacosamide Lacosamide Tablet 400mg daily (administered twice daily)

Participant Flow:   Overall Study
    Placebo     Lacosamide  
STARTED     81     78  
COMPLETED     50     46  
NOT COMPLETED     31     32  
Adverse Event                 10                 18  
Lack of Efficacy                 11                 5  
Withdrawal by Subject                 4                 3  
Protocol Violation                 3                 3  
Non-compliance with drug study                 1                 0  
Lost to Follow-up                 1                 3  
Other: Personal / Family problems                 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.
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Reporting Groups
  Description
Placebo Matching placebo tablet (administered twice daily)
Lacosamide Lacosamide Tablet 400mg daily (administered twice daily)
Total Total of all reporting groups

Baseline Measures
    Placebo     Lacosamide     Total  
Number of Participants  
[units: participants]
  81     78     159  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     79     76     155  
>=65 years     2     2     4  
Age  
[units: years]
Mean ± Standard Deviation
  50.4  ± 10.5     48.9  ± 11.1     49.7  ± 10.8  
Gender  
[units: participants]
     
Female     77     71     148  
Male     4     7     11  
Region of Enrollment  
[units: participants]
     
United States     81     78     159  



  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:   Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase   [ Time Frame: Baseline, Last 2 weeks of the 12 week Treatment Phase ]

8.  Secondary:   Change From Baseline in Evening Pain Score 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:   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 ]

10.  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 ]

11.  Secondary:   Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase   [ Time Frame: 12-week Treatment Phase ]

12.  Secondary:   Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase   [ Time Frame: 12-week Treatment Phase ]

13.  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 ]

14.  Secondary:   Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12   [ Time Frame: End of the Maintenance Phase/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 Clinical Trial Call Center
phone: +1 877 822 9493


No publications provided


Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00401830     History of Changes
Other Study ID Numbers: SP0887
Study First Received: November 9, 2006
Results First Received: September 22, 2009
Last Updated: September 19, 2014
Health Authority: United States: Food and Drug Administration