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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
188
Study drug is to be self-administered twice each day by the patient. Each day the first dose of study drug should be taken preferably one hour prior to, OR one hour after the first meal (breakfast) of the day. The second and final dose each day should be taken with a glass of water at least one hour after the last meal immediately before retiring to sleep.
Study drug is to be self-administered twice each day by the patient. Each day the first dose of study drug should be taken preferably one hour prior to, OR one hour after the first meal (breakfast) of the day. The second and final dose each day should be taken with a glass of water at least one hour after the last meal immediately before retiring to sleep.
Premier Research
Phoenix, Arizona, United States
Change from baseline to the last week of treatment in daily pain scores
Change from baseline to the last week of treatment in daily (24-hour recall) pain scores comparing NXN-462 with placebo
Time frame: 4 weeks
average weekly change in pain score from baseline to the end of the Treatment Period
Time frame: four weeks
Analysis of percent change from baseline in daily pain score
Time frame: four weeks
percentage of responders
subjects with a ≥30% and ≥50% reduction in pain score from baseline to the last week of treatment
Time frame: four weeks
Percentage of subjects with moderate or much improvement at the end of the Treatment Period, according to Patient Global Impression of Change
Time frame: four weeks
Change from baseline to the end of the Treatment Period in Pain Quality Assessment Scale score
Time frame: four weeks
Rescue medication consumption
Time frame: four weeks
Adverse events (AEs), vital signs, and clinical laboratory tests
Time frame: six weeks
Change from baseline to the end of the Treatment Period in Modified Brief Pain Inventory Short Form score, pain interference subscale
Time frame: four weeks
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