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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Eslicarbazepine acetate

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