Study to Evaluate the Safety and Analgesic Activity of ATx08-001 in Subjects With Postherpetic Neuralgia
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
This is a Phase 2 randomized, double-blind, placebo-controlled, multiple-dose, multicenter,
parallel-group study to evaluate the analgesic activity of ATx08-001, a novel selective
peroxisome proliferator-activated receptor modulator (SPPARM), in subjects with
moderate-to-severe postherpetic neuralgia pain. Eligible subjects will be randomized to
receive either placebo or Atx08-001. Study drug will be administered orally twice a day for 7
days. Subjects will be evaluated for neuropathic pain intensity at regular intervals over a 6
hour period on Day 1 following the first dose of study drug. They will then be discharged
from the clinic and will complete diary assessments of pain severity twice a day at home.
Subjects will be asked to return to the clinic on Day 8 to complete their last set of pain
evaluations.
Phase:
Phase 2
Details
Lead Sponsor:
Aestus Therapeutics
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS) Parallax Clinical Research, LLC Symbiance, Inc