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
Detailed 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
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Arizona
- Premier Research, Phoenix, Arizona, 85027
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California
- Northern California Research, Sacramento, California, 95821
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New Mexico
- Albuquerque Clinical Trials, Inc, Albuquerque, New Mexico, 87102
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Oklahoma
- Lynn Health Science Institute, Oklahoma City, Oklahoma, 73112
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Texas
- ClinRx Research LLC, Plano, Texas, 75080
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Illinois
- Medex Healthcare Research, Inc., Chicago, Illinois, 60602
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Tennessee
- Nashville Neuroscience Group, Nashville, Tennessee, 37203
- Trinity Clinical Research, Tullahoma, Tennessee, 37388