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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeurAxon Inc.

Criteria

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