NCT00612105

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Proof-of-Concept Study to Evaluate the Efficacy of Maximally Tolerated Doses of Retigabine vs. Placebo in Reducing the Pain Associated With Post-Herpetic Neuralgia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a Phase 2a proof of concept study evaluating the safety/efficacy of retigabine vs. placebo in patients with post-herpetic neuralgia. After screening, patients will enter a maximum 6 week titration period followed by a 4 week maintenance period and a 3 week taper phase.

Conditions

• Postherpetic Neuralgia

Interventions

Type	Name	Description
DRUG	Retigabine	150mg/day up to 900mg/day
DRUG	Placebo	daily

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-05-01
• Completion: 2009-12-01
• First posted: 2008-02-11
• Last updated: 2018-05-08
• Results posted: 2012-01-11

Locations

45 sites across 2 countries: United States, South Africa