Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing 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.

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