Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia
Status: | Completed |
---|---|
Conditions: | Postherpatic Neuralgia |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/3/2014 |
Start Date: | January 2013 |
End Date: | December 2013 |
Contact: | Trisha Mortier, CCRA |
Email: | tmortier@synteract.com |
Phone: | 760 268 8233 |
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)
The purpose of this study is to investigate whether NXN-462, a selective nNOS inhibitor, is
effective in reducing pain levels in patients with post-herpetic neuralgia.
effective in reducing pain levels in patients with post-herpetic neuralgia.
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.
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.
Inclusion 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
Exclusion Criteria:
- 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
We found this trial at
26
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