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 trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.

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.

• Drug: Lacosamide
  Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg
  Other Names:

  • Vimpat
  • Harkoseride
• Other: Placebo
  Matching placebo tablet administered twice daily

• Placebo Comparator: Placebo
  Intervention: Other: Placebo
• Experimental: Lacosamide
  Lacosamide Tablet 400mg daily
  Intervention: Drug: Lacosamide

Inclusion Criteria:

• Males or females, 18 to 65 years old
• Fulfills all 3 points of American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia
• At least moderate pain (pain intensity ≥ 5 on Likert pain scale (0-10) during the 7 days prior to Baseline)
• Fibromyalgia Impact Questionnaire (FIQ) total score ≥ 50
• Completed an adequate washout period for excluded medications prior to beginning the Baseline Diary Phase

Exclusion Criteria:

• Symptomatic regional or structural rheumatic disease
• Diagnosed neuropathic pain syndrome
• Receiving treatment with neurostimulating devices
• Significant psychopathology
• History of chronic alcohol or drug abuse within 6 months prior to Screening
• Been hospitalized for psychiatric or behavioral reasons within 6 months prior to Screening
• Clinically significant abnormal vitals, cardiac dysfunction and /or arrhythmias
• Taken neuroleptics, serotonin and norepinephrine reuptake inhibitors (SNRIs) or tricyclic antidepressants (TCAs)
• Other medical conditions that could compromise the subject's ability to participate in the study