NCT01129960

Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain

A Phase 3, Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Diabetic Neuropathic Pain

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	Eslicarbazepine acetate (BIA 2-093)	Tablets will be used.
DRUG	Placebo	Tablets will be used.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-05-25
• Last updated: 2014-07-18
• Results posted: 2014-07-18

Locations

1 site across 1 country: Portugal