Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy of retigabine vs. placebo in reducing pain associated with post-herpetic neuralgia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Ezogabine

Criteria

Inclusion Criteria:

• Ability to provide informed consent

• Male or female subjects

• 18-85 years of age

• PHN for more than 6 months after the healing of herpes zoster skin rash

• Has a pain score at screening and randomization that qualifies

Exclusion Criteria:

• Other significant pain that may potentially confound PHN pain assessment

• Previous neurolytic or neurosurgical therapy for PHN

• Subject has evidence of a progressive central nervous system (CNS) disease (e.g. CNS lupus, tumors, multiple sclerosis, Alzheimer's), lesion, or encephalopathy

• Significant psychiatric or neuropsychiatric disorders including but not limited to severe depression, bipolar disorder or schizophrenia spectrum disorder, history of suicide attempt, or recent history of suicidal ideation

• Has clinically significant abnormalities on physical examination, vital signs, ECG, or laboratory tests at the screening visit