Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy

Exclusion Criteria

• •Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
• •Significant or unstable medical or psychiatric disorders
• •Drug or alcohol abuse in the preceding 2 years
• •Peripheral vascular disease with a history of amputation, except amputation of toes
• •Severe renal function impairment, as shown by calculated creatinine clearance values \< 30 mL/min at screening
• •Relevant clinical laboratory abnormalities (e.g., Na+ \<130 mmol/L, alanine (ALT) or aspartate (AST) transaminases \>2.0 times the upper limit of normal, white blood cell count (WBC) \<2,500 cells/mm3)
• •Previous participation in any study with eslicarbazepine acetate
• •Pregnancy or breast feeding
• •History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
• •History of non-compliance
• •Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.
• •Participation in a clinical study within 3 months prior to screening
• •Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial