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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NXN-462 | Experimental | capsule, 200 mg, bi.d. 28-days |
|
| Placebo | Placebo Comparator | capsule, b.i.d. 28-days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NXN-462 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| average weekly change in pain score from baseline to the end of the Treatment Period | four weeks | |
| Analysis of percent change from baseline in daily pain score | four weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Lategan, D.Phil. | NeurAxon Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Research | Phoenix | Arizona | 85027 | United States | ||
| University of Southern California |
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|
| Placebo | Drug | 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. |
|
| percentage of responders |
subjects with a ≥30% and ≥50% reduction in pain score from baseline to the last week of treatment |
| four weeks |
| Percentage of subjects with moderate or much improvement at the end of the Treatment Period, according to Patient Global Impression of Change | four weeks |
| Change from baseline to the end of the Treatment Period in Pain Quality Assessment Scale score | four weeks |
| Rescue medication consumption | four weeks |
| Adverse events (AEs), vital signs, and clinical laboratory tests | six weeks |
| Change from baseline to the end of the Treatment Period in Modified Brief Pain Inventory Short Form score, pain interference subscale | four weeks |
| Los Angeles |
| California |
| 90033 |
| United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| Neurological Research Institute | Santa Monica | California | United States |
| Meridien Research | Brooksville | Florida | 34601 | United States |
| FPA Clinical Research | Kissimmee | Florida | 34741 | United States |
| Suncoast Clinical Research | New Port Richey | Florida | United States |
| Compass Research LLC | Orlando | Florida | 32806 | United States |
| Meridien Research | Tampa | Florida | 33606 | United States |
| Medex Healthcare Research, Inc. | Chicago | Illinois | 60602 | United States |
| Integrated Clinical Trial Services | West Des Moines | Iowa | United States |
| IRC Clinics | Towson | Maryland | 21204 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Michigan Head-Pain and Neurological Institute | Ann Arbor | Michigan | United States |
| Albuquerque Clinical Trials, Inc | Albuquerque | New Mexico | 87102 | United States |
| Clinical Trials of America, Inc. | Hickory | North Carolina | 01845 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Pain Specialist of Charleston, P.A. | Mt. Pleasant | South Carolina | United States |
| Nashville Neuroscience Group | Nashville | Tennessee | 37203 | United States |
| Trinity Clinical Research | Tullahoma | Tennessee | 37388 | United States |
| ClinRx Research LLC | Plano | Texas | 75080 | United States |
| Progressive Clinical Research | San Antonio | Texas | United States |
| Manna Research Vancouver | Vancouver | British Columbia | V6J 1S3 | Canada |
| Manna Research, Inc. | Toronto | Ontario | M9W 4L6 | Canada |
| Kells Medical Research Group - Manna Research | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D006562 | Herpes Zoster |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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