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

• 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 ] [ Designated as safety issue: No ]
  The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
  
  
• 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 ] [ Designated as safety issue: No ]
  The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
  
  

• 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 ] [ Designated as safety issue: No ]
  The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia
  
  
• 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 ] [ Designated as safety issue: No ]
  Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.
  
  
• 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 ] [ Designated as safety issue: No ]
  Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)
  
  
• 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 ] [ Designated as safety issue: No ]
  General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)
  
  
• 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 ] [ Designated as safety issue: No ]
  An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
  
  
• 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 ] [ Designated as safety issue: No ]
  An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
  
  
• 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 ] [ Designated as safety issue: No ]
  The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).
  
  
• 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 ] [ Designated as safety issue: No ]
  The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.
  
  
• Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase [ Time Frame: 12-week Treatment Phase ] [ Designated as safety issue: No ]
  Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.
  
  
• Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase [ Time Frame: 12-week Treatment Phase ] [ Designated as safety issue: No ]
  Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).
  
  
• 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 ] [ Designated as safety issue: No ]
  All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.
  
  
• Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12 [ Time Frame: End of the Maintenance Phase/Week 12 ] [ Designated as safety issue: No ]
  

This was a proof-of-concept study and not powered for statistical comparisons.

The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive either lacosamide 400mg/day or placebo during the Maintenance Phase. Subjects assigned to lacosamide were titrated from 100mg/day to 400mg/day at weekly intervals of 100mg. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase. No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.