Conditions: Painful Diabetic Neuropathy
Keywords: Diabetic Neuropathic Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 332
Healthy volunteers: no

Brief summary:
The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate (ESL) as therapy in subjects with Diabetic Neuropathic Pain (DNP) over a 15 week treatment phase.

Detailed description:
Diabetic neuropathic pain (DNP) is one of the most common complications of diabetes mellitus. It currently affects about 1% of the population but its prevalence is expected to increase in coming years (European Medicines Agency 2007) in step with the increase in diabetes mellitus prevalence, which is expected to affect 220 million people by 2010

The clinical development of ESL to treat neuropathic pain is based on its chemical and pharmacodynamic relationship to sodium channel blockers, including carbamazepine, which is effective for treating some neuropathic pain conditions. Preclinical data supports the theoretical background.

This study will examine the efficacy, safety, tolerability and pharmacokinetics of Eslicarbazepine acetate for the treatment of diabetic neuropathic pain.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Eslicarbazepine acetate (BIA 2-093) intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets will be used. intervention 2: Tablets will be used.

Protocol document: