Efficacy and safety of eslicarbazepine acetate as therapy in patients with fibromyalgia: a double-blind, randomized, placebo-controlled, parallel-group, multicentre clinical trial.

Main Inclusion Criteria at V1:

1. Patient is male or female, aged 18 or older;

2. Patient meets the ACR 1990 diagnostic criteria for FMS (widespread pain for at least 3 months and pain in at least 11 of 18 tender points);

3. Patient use of allowable nonpharmacological therapies must have been stable for at least 4 weeks prior to V1 (Screening Visit) and must be maintained at the stable regimen throughout the study.

Main Exclusion Criteria:

1. Patient has any of the following: an inflammatory muscle or rheumatologic disease other than FMS; multiple sclerosis; active infections; untreated endocrine disorders; uncontrolled hypo or hyper thyroidism of any type;

2. Patients whose pain is not due primarily to FMS;

3. Patient underwent tender point injection within 30 days before V1 (Screening Visit) and/or patient is unwilling to refrain from tender point injection throughout the study;

4. Patient has abnormal values for antinuclear antibody (ANA > 1/160) or rheumatoid factor (RF > 15 IU/mL) at V1 (Screening Visit);

5. Patient has abnormal Westergren erythrocyte sedimentation rate (ESR) at V1 (Screening Visit) (ESR > 40 mm/h);

6. Patient has creatinine clearance lower than 60 mL/min at Screening;

7. Patient has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥ 35 or a score of 4 to 6 on question 10 of the MADRS at V1 (Screening Visit);

8. Patient used prohibited concomitant medications during the 2 week Baseline Period or used fluoxetine during the 30 days before V1 (Screening Visit);

9. Patient used opiates every day for the 30 days before V1 (Screening Visit) for the control of pain related to FMS.