Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia
- Registration Number
- NCT01748877
- Lead Sponsor
- NeurAxon Inc.
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NXN-462 NXN-462 capsule, 200 mg, bi.d. 28-days Placebo Placebo capsule, b.i.d. 28-days
- Primary Outcome Measures
Name Time Method Change from baseline to the last week of treatment in daily pain scores 4 weeks Change from baseline to the last week of treatment in daily (24-hour recall) pain scores comparing NXN-462 with placebo
- Secondary Outcome Measures
Name Time Method Analysis of percent change from baseline in daily pain score four weeks percentage of responders four weeks subjects with a ≥30% and ≥50% reduction in pain score from baseline to the last week of treatment
Percentage of subjects with moderate or much improvement at the end of the Treatment Period, according to Patient Global Impression of Change four weeks average weekly change in pain score from baseline to the end of the Treatment Period four weeks Adverse events (AEs), vital signs, and clinical laboratory tests six weeks Change from baseline to the end of the Treatment Period in Pain Quality Assessment Scale score four weeks Rescue medication consumption four weeks Change from baseline to the end of the Treatment Period in Modified Brief Pain Inventory Short Form score, pain interference subscale four weeks
Trial Locations
- Locations (24)
Neurological Research Institute
🇺🇸Santa Monica, California, United States
FPA Clinical Research
🇺🇸Kissimmee, Florida, United States
Manna Research, Inc.
🇨🇦Toronto, Ontario, Canada
Albuquerque Clinical Trials, Inc
🇺🇸Albuquerque, New Mexico, United States
Manna Research Vancouver
🇨🇦Vancouver, British Columbia, Canada
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Pain Specialist of Charleston, P.A.
🇺🇸Mt. Pleasant, South Carolina, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Medex Healthcare Research, Inc.
🇺🇸Chicago, Illinois, United States
Clinical Trials of America, Inc.
🇺🇸Hickory, North Carolina, United States
Integrated Clinical Trial Services
🇺🇸West Des Moines, Iowa, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
ClinRx Research LLC
🇺🇸Plano, Texas, United States
IRC Clinics
🇺🇸Towson, Maryland, United States
Northern California Research
🇺🇸Sacramento, California, United States
Premier Research
🇺🇸Phoenix, Arizona, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Compass Research LLC
🇺🇸Orlando, Florida, United States
Michigan Head-Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Kells Medical Research Group - Manna Research
🇨🇦Pointe-Claire, Quebec, Canada
Trinity Clinical Research
🇺🇸Tullahoma, Tennessee, United States
Nashville Neuroscience Group
🇺🇸Nashville, Tennessee, United States