Civamide Nasal Solution for Postherpetic Neuralgia of the Trigeminal Nerve
Status:
Terminated
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
Herpes zoster (commonly referred to as "shingles") results from the reactivation of the
varicella-zoster virus acquired during a primary infection, usually chickenpox. The virus
lays dormant in the cells of the nerves until activated. Once activated, patients develop a
characteristic red blistering rash which crusts and heals in 2 - 4 weeks. Postherpetic
neuralgia (PHN), the term for pain persisting after the herpes zoster (HZ) eruption heals, is
the most common and most feared complication of herpes zoster infection. The drug, Civamide
is thought to desensitize the nerves and decrease the pain of PHN. This is the pharmacologic
rationale for its use in the nose in postherpetic neuralgia of the trigeminal nerve, a nerve
that is in the nose and transmits pain from the face. The objective of this study is to
evaluate the safety and efficacy of intranasally administered Civamide (0.01%) for the
treatment of moderate to severe daily pain associated with postherpetic neuralgia of the
trigeminal nerve. Neuropathic pain must have persisted for ≥ 12 months.