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

Inclusion Criteria: * Written informed consent to participate in the study * Men and women aged 18 years or older * Diagnosis of diabetes mellitus Type 1 or 2 * Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment * Stable glycemic control: (total glycated haemoglobin \[HbA1c\] level ≤ 11% at screening) * Cooperation and willingness to complete all aspects of the study * Completion of at least 4 daily diaries during the week preceding randomisation * A minimum average daily pain score of 4 on the Numeric rating pain scale (NRPS) in the last 4 diary entries before randomisation. 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