Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia

Completed · Phase 2 · Has a placebo group

Conditions studied: Post Herpetic Neuralgia

In brief

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.

Key facts

Study ID

NCT01748877

Run by

NeurAxon Inc.

People needed

188

Starts

2013-01-01

Expected to finish

2014-06-01

Last updated by the study team

2014-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Premier Research — Phoenix, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• Northern California Research — Sacramento, California, United States
• Neurological Research Institute — Santa Monica, California, United States
• Meridien Research — Brooksville, Florida, United States
• FPA Clinical Research — Kissimmee, Florida, United States
• Suncoast Clinical Research — New Port Richey, Florida, United States
• Compass Research LLC — Orlando, Florida, United States
• Meridien Research — Tampa, Florida, United States
• Medex Healthcare Research, Inc. — Chicago, Illinois, United States
• Integrated Clinical Trial Services — West Des Moines, Iowa, United States
• IRC Clinics — Towson, Maryland, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• Michigan Head-Pain and Neurological Institute — Ann Arbor, Michigan, United States
• Albuquerque Clinical Trials, Inc — Albuquerque, New Mexico, United States
• Clinical Trials of America, Inc. — Hickory, North Carolina, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Pain Specialist of Charleston, P.A. — Mt. Pleasant, South Carolina, United States
• Nashville Neuroscience Group — Nashville, Tennessee, United States
• Trinity Clinical Research — Tullahoma, Tennessee, United States
• ClinRx Research LLC — Plano, Texas, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• Manna Research Vancouver — Vancouver, British Columbia, Canada
• Manna Research, Inc. — Toronto, Ontario, Canada
• Kells Medical Research Group - Manna Research — Pointe-Claire, Quebec, Canada

Full record on ClinicalTrials.gov

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