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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
North Myrtle Beach, South Carolina 29582
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials