Study to Evaluate the Safety and Analgesic Activity of ATx08-001 in Subjects With Postherpetic Neuralgia
Condition: Postherpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Aestus has identified a novel selective peroxisome proliferator-activated receptor modulator
      (SPPARM), with promising potential for the treatment of neuropathic pain. PPARs are nuclear
      receptors that control many cellular and metabolic processes and are readily modulated by a
      variety of different drugs. Drugs modulating this target have been shown to improve blood
      glucose levels and levels of blood lipids, and may reduce the risk of atherosclerosis.

      The primary objective of the study is to evaluate the safety and analgesic efficacy of
      ATx08-001 at doses of 2.5 mg bid and 7.5 mg bid compared to placebo for the control of
      moderate-to-severe postherpetic neuralgia (PHN) pain.

      The secondary objectives are:

        -  To determine the approximate time to onset of analgesia following administration of
           study drug

        -  To determine the approximate duration of analgesia following study drug administration

        -  To determine the percentage of treatment responders among subjects receiving ATx08-001

      Subjects will be given a diary and instructed to record their postherpetic neuralgia pain
      severity on a Numerical Pain Rating Scale (NPRS - 12) "over the past 12 hours" on a 0 - 10
      scale with "0" being no pain and "10" being the most severe pain the subject could imagine,
      each morning and night for three consecutive days prior to returning for the Treatment Visit.

      The Treatment Visit will consist of an in-clinic 6-hour observation period. To be eligible
      for dosing, immediately before dosing subjects must report a baseline score of 4 or greater
      on the following Numerical Pain Rating Scale (NPRS-NOW) question: "How would you rate your
      pain RIGHT NOW using a zero to ten scale, where zero equals no pain and ten is the worst pain
      you can imagine." Qualified subjects will be administered study drug followed by a 6-hour
      observation in-clinic period. In addition to the Baseline pain intensity assessment conducted
      just prior to drug administration (Time 0), pain intensity scores (pain right now) will be
      assessed using the NPRS-NOW at 30 minutes, 1, 2, 3, 4, and 6 hours following study drug
      administration. Pain relief compared with Baseline will be assessed at those same time points
      using a 5-point numerical pain relief (NPR) scale, where 0 = no relief, 1 = a little relief,
      2 = some relief, 3 = a lot of relief, and 4 = complete relief.

      Subjects will be discharged from the clinic at the end of the 6-hour observation period and
      will be instructed to record postherpetic neuralgia pain severity (NPRS-NOW scores) and pain
      relief (PAR scores) at 8, 10 and 12 hours following dosing in a diary.
    

Intervention name(s): ATx08-001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ATx08-001 will be administered as a 6mm white film coated tablet of 2.5 mg strength, to be taken orally at a dose of 2.5 mg or 7.5 mg, twice a day approximately every 12 hours over an 8 day period.; Placebo will be administered as a 6mm white film coated tablet, twice a day approximately every 12 hours over an 8 day period. Placebo is identical in appearance to the ATx 08-001 tablet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postherpetic neuralgia; shingles; analgesia; neuropathic pain