Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)
Status: | Completed |
---|---|
Conditions: | Postherpatic Neuralgia |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 5/10/2018 |
Start Date: | October 2007 |
End Date: | December 2009 |
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
The purpose of the study is to evaluate the efficacy of retigabine vs. placebo in reducing
pain associated with post-herpetic neuralgia.
pain associated with post-herpetic neuralgia.
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.
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.
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
We found this trial at
40
sites
North Myrtle Beach, South Carolina 29582
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