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)

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.

Study Overview

• Status: Completed
• Conditions: Post Herpetic Neuralgia
• Intervention / Treatment: Drug: NXN-462; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6J 1S3
      • Manna Research Vancouver
  • Ontario
    • Toronto, Ontario, Canada, M9W 4L6
      • Manna Research, Inc.
  • Quebec
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Kells Medical Research Group - Manna Research
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85027
      • Premier Research
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Sacramento, California, United States, 95821
      • Northern California Research
    • Santa Monica, California, United States
      • Neurological Research Institute
  • Florida
    • Brooksville, Florida, United States, 34601
      • Meridien Research
    • Kissimmee, Florida, United States, 34741
      • FPA Clinical Research
    • New Port Richey, Florida, United States
      • Suncoast Clinical Research
    • Orlando, Florida, United States, 32806
      • Compass Research LLC
    • Tampa, Florida, United States, 33606
      • Meridien Research
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Medex Healthcare Research, Inc.
  • Iowa
    • West Des Moines, Iowa, United States
      • Integrated Clinical Trial Services
  • Maryland
    • Towson, Maryland, United States, 21204
      • IRC Clinics
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
  • Michigan
    • Ann Arbor, Michigan, United States
      • Michigan Head-Pain and Neurological Institute
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc
  • North Carolina
    • Hickory, North Carolina, United States, 01845
      • Clinical Trials of America, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • South Carolina
    • Mt. Pleasant, South Carolina, United States
      • Pain Specialist of Charleston, P.A.
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Nashville Neuroscience Group
    • Tullahoma, Tennessee, United States, 37388
      • Trinity Clinical Research
  • Texas
    • Plano, Texas, United States, 75080
      • ClinRx Research LLC
    • San Antonio, Texas, United States
      • Progressive Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NXN-462; capsule, 200 mg, bi.d. 28-days	Drug: NXN-462; Study drug is to be self-administered twice each day by the patient. Each day the first dose of study drug should be taken preferably one hour prior to, OR one hour after the first meal (breakfast) of the day. The second and final dose each day should be taken with a glass of water at least one hour after the last meal immediately before retiring to sleep.; Other Names: NXN-462 dihydrochloride
Placebo Comparator: Placebo; capsule, b.i.d. 28-days	Drug: Placebo; Study drug is to be self-administered twice each day by the patient. Each day the first dose of study drug should be taken preferably one hour prior to, OR one hour after the first meal (breakfast) of the day. The second and final dose each day should be taken with a glass of water at least one hour after the last meal immediately before retiring to sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to the last week of treatment in daily pain scores	Change from baseline to the last week of treatment in daily (24-hour recall) pain scores comparing NXN-462 with placebo	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
average weekly change in pain score from baseline to the end of the Treatment Period		four weeks
Analysis of percent change from baseline in daily pain score		four weeks
percentage of responders	subjects with a ≥30% and ≥50% reduction in pain score from baseline to the last week of treatment	four weeks
Percentage of subjects with moderate or much improvement at the end of the Treatment Period, according to Patient Global Impression of Change		four weeks
Change from baseline to the end of the Treatment Period in Pain Quality Assessment Scale score		four weeks
Rescue medication consumption		four weeks
Adverse events (AEs), vital signs, and clinical laboratory tests		six weeks
Change from baseline to the end of the Treatment Period in Modified Brief Pain Inventory Short Form score, pain interference subscale		four weeks

Collaborators and Investigators

• Sponsor: NeurAxon Inc.
• Investigators: Study Director: Thomas Lategan, D.Phil., NeurAxon Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 11, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 13, 2012

Study Record Updates

• Last Update Posted (Estimate): June 19, 2014
• Last Update Submitted That Met QC Criteria: June 18, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: sleep; neuropathic pain; post herpetic neuralgia; shingles,
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic
• Other Study ID Numbers: NXN-462-201