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

NeurAxon

Status and phase

Completed

Phase 2

Conditions

Post Herpetic Neuralgia

Treatments

Drug: Placebo

Drug: NXN-462

Study type

Interventional

Funder types

Industry

Identifiers

NCT01748877

NXN-462-201

Details and patient eligibility

About

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.

Full 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.

Enrollment

188 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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