Post Herpetic Neuralgia Clinical Trial
Official title:
A Phase 3, Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Post-Herpetic Neuralgia
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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