Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Intervention: Eslicarbazepine acetate; Placebo
Intervention description: Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.; oral route
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 557.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pain diabetes neuropathy

Summary:

      The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL)
      as therapy for patients with painful diabetic neuropathy.
    

Eligibility criteria:

        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