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

Bausch Health

Status and phase

Completed

Phase 2

Conditions

Postherpetic Neuralgia

Treatments

Drug: Placebo

Drug: Retigabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00612105

VRX-RET-E22-NP201

Details and patient eligibility

About

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

Full 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.

Enrollment

187 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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