NCT01124097

Eslicarbazepine Acetate as Therapy in Post-Herpetic Neuralgia

A Phase 3, Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Post-Herpetic Neuralgia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (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 Post-herpetic Neuralgia (PHN) over a 15 week treatment phase.

Detailed description

Post-herpetic neuralgia (PHN) is a syndrome of intractable pain following an acute infection of herpes zoster (shingles). Treatment for PHN is often suboptimal. More than 50% of the subjects fail to respond to pharmacological treatments or experience intolerable side effects. 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 post herpetic neuralgia.

Conditions

• Post Herpetic Neuralgia

Interventions

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

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-05-14
• Last updated: 2014-04-07
• Results posted: 2014-04-07

Locations

1 site across 1 country: Germany