Status:
COMPLETED
Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Postherpetic Neuralgia
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 titra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00612105
Start Date
October 1 2007
End Date
December 1 2009
Last Update
May 8 2018
Active Locations (45)
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1
Birmingham, Alabama, United States, 35215
2
Mesa, Arizona, United States, 85210
3
Tucson, Arizona, United States, 85741
4
Little Rock, Arkansas, United States, 72205