Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-04-08 @ 10:43 PM
Study NCT ID:
NCT00612105
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2008-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)
Sponsor:
Bausch Health Americas, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: