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COMPLETEDPHASE2

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

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia (PHN)

NCT01748877•NeurAxon Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+3 more criteria

Locations (25)

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

Key Dates

Start Date

January 1, 2013

Primary Completion Date

June 1, 2014

Completion Date

June 1, 2014

Last Updated

June 19, 2014

Enrollment

188

ACTUAL participants

Conditions

Post Herpetic Neuralgia

Interventions

NXN-462

DRUG

Placebo

DRUG

Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain

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Spinal Cord InjuriesNerve Injury+7 more

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RECRUITINGPHASE1

A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients.

NCT06218784

Post Herpetic NeuralgiaPain+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 19, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain

A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients.

Predictive Models for the Treatment of Recurrent Herpes Zoster Neuralgia Following Spinal Cord Electrical Stimulation.

Acupuncture as Treatment of Post-herpetic Neuralgia: A RCT A Double-blinded Randomized Clinical Trial.

Eslicarbazepine Acetate as Therapy in Post-Herpetic Neuralgia