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A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia (PHN)

Description

NXN-462 is designed to target the nitric oxide synthase system (NOS), specifically the neuronal NOS (nNOS) isoform. By design, NXN-462 is a potent inhibitor of nNOS with good affinity, and has little or no affinity for a range of G protein-coupled receptors, ion channels, and enzymes. NXN-462 is being developed as an oral therapy for the treatment of neuropathic pain syndromes, including PHN. This drug design strategy provides a new therapeutic paradigm for the treatment of chronic neuropathic pain.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion Criteria

  • Male, or a non-pregnant, non-lactating female 18 years or older
  • Have voluntarily provided written informed consent
  • able to speak, read, write, and understand English
  • clinical diagnosis of PHN for a minimum of 6 months
  • pain intensity score of ≥3 on a 0-10 Numerical Rating Scale (NRS) at the Screening Visit
  • generally in good health (other than PHN) at Screening

  • Are pregnant and/or lactating
  • Diagnosis of any chronic pain syndrome that would interfere with the assessment of PHN
  • evidence of multiple causes of neuropathic pain,e.g.lumbar radiculopathy in the lumbosacral area
  • Have had neuroablation or neurosurgical intervention for PHN
  • Have been taking opioid analgesics for >5 days/week
  • Have received nerve block or intrathecal analgesia within 6 weeks of the study
  • History of significant gastrointestinal disease, liver disease, renal disease, endocrine disease, or cardiovascular disease
  • clinically significant abnormal clinical laboratory test results or vital signs
  • Are immunocompromised or immunosuppressed for any reason
  • History of alcohol or other substance abuse (not including nicotine or tobacco) within 5 years
  • Significant psychiatric disorder which requires drug treatment (except depression or anxiety treated with Selective Serotonin Re-uptake Inhibitors)
  • Have received an investigational drug or have used an investigational device within 30 days of Screening.
  • Have previously been randomized to this study

Sites

  • Arizona

    • Premier Research, Phoenix, Arizona, 85027
  • California

    • Northern California Research, Sacramento, California, 95821
  • New Mexico

    • Albuquerque Clinical Trials, Inc, Albuquerque, New Mexico, 87102
  • Oklahoma

    • Lynn Health Science Institute, Oklahoma City, Oklahoma, 73112
  • Texas

    • ClinRx Research LLC, Plano, Texas, 75080
  • Illinois

    • Medex Healthcare Research, Inc., Chicago, Illinois, 60602
  • Tennessee

    • Nashville Neuroscience Group, Nashville, Tennessee, 37203
    • Trinity Clinical Research, Tullahoma, Tennessee, 37388
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