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

This study is currently recruiting participants.
Verified December 2013 by NeurAxon Inc.
Sponsor:
Information provided by (Responsible Party):
NeurAxon Inc.
ClinicalTrials.gov Identifier:
NCT01748877
First received: December 11, 2012
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Post Herpetic Neuralgia
Drug: NXN-462
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by NeurAxon Inc.:

Primary Outcome Measures:
  • Change from baseline to the last week of treatment in daily pain scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline to the last week of treatment in daily (24-hour recall) pain scores comparing NXN-462 with placebo


Secondary Outcome Measures:
  • average weekly change in pain score from baseline to the end of the Treatment Period [ Time Frame: four weeks ] [ Designated as safety issue: No ]
  • Analysis of percent change from baseline in daily pain score [ Time Frame: four weeks ] [ Designated as safety issue: No ]
  • percentage of responders [ Time Frame: four weeks ] [ Designated as safety issue: No ]
    subjects with a ≥30% and ≥50% reduction in pain score from baseline to the last week of treatment

  • Percentage of subjects with moderate or much improvement at the end of the Treatment Period, according to Patient Global Impression of Change [ Time Frame: four weeks ] [ Designated as safety issue: No ]
  • Change from baseline to the end of the Treatment Period in Pain Quality Assessment Scale score [ Time Frame: four weeks ] [ Designated as safety issue: No ]
  • Rescue medication consumption [ Time Frame: four weeks ] [ Designated as safety issue: No ]
  • Adverse events (AEs), vital signs, and clinical laboratory tests [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to the end of the Treatment Period in Modified Brief Pain Inventory Short Form score, pain interference subscale [ Time Frame: four weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748877

Contacts
Contact: Trisha Mortier, CCRA 760 268 8233 tmortier@synteract.com
Contact: Kyle Iwasaki 760 476 8867 kiwasaki@synteract.com

  Hide Study Locations
Locations
United States, Arizona
Premier Research Recruiting
Phoenix, Arizona, United States, 85027
Contact: Jan Blackman       jan.blackman@premier-research.com   
Principal Investigator: Kyle Patrick, MD         
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Salma Akhter    323-442-6221    salma.akhter@med.usc.edu   
Principal Investigator: Said Beydoun, MD         
Neurovations Withdrawn
Napa, California, United States, 94558
Northern California Research Recruiting
Sacramento, California, United States, 95821
Contact: Stacy Woodward       swoodward@norcare.net   
Principal Investigator: Douglas Young, MD         
Neurological Research Institute Recruiting
Santa Monica, California, United States
Contact: Jaime Latorre    310-315-1456    jlatorre@drkudrow.com   
Principal Investigator: David B Kudrow, MD         
United States, Florida
Meridien Research Recruiting
Brooksville, Florida, United States, 34601
Contact: Katie Leonard, RN    352-597-8839    kleonard@meridienresearch.net   
Principal Investigator: Kelli Maw, MD         
FPA Clinical Research Recruiting
Kissimmee, Florida, United States, 34741
Contact: Esther Santiago    407-846-6625    esther.santiago@chappelhealthandwellness.com   
Principal Investigator: Christopher Chappel, MD         
Suncoast Clinical Research Recruiting
New Port Richey, Florida, United States
Contact: Krystal Smith    727-849-4131    ksmith@suncoastclinicalresearch.com   
Principal Investigator: Lisa M Cohen, DO         
Compass Research LLC Recruiting
Orlando, Florida, United States, 32806
Contact: Kyle Smith    407-426-9299    kylesmith@compassresearch.com   
Principal Investigator: Kevin Radbill, MD         
Sarasota Pain Medicine Research Withdrawn
Sarasota, Florida, United States
Meridien Research Recruiting
Tampa, Florida, United States, 33606
Contact: Collette Armbruster    813-877-8839    carmbruster@meridienresearch.net   
Principal Investigator: Cynthia Huffman, MD         
United States, Georgia
Dekalb Neurology Associates Withdrawn
Decatur, Georgia, United States
United States, Illinois
Medex Healthcare Research, Inc. Recruiting
Chicago, Illinois, United States, 60602
Contact: Sudha Lukka    312-348-7248    sudha.lukka@medexhealth.net   
Principal Investigator: Stephen Blatt, MD         
United States, Iowa
Integrated Clinical Trial Services Recruiting
West Des Moines, Iowa, United States
Contact: Kristine Majors    515-327-4782    kmajors@ictsiowa.com   
Principal Investigator: Kenneth Pollack, MD         
United States, Maryland
IRC Clinics Recruiting
Towson, Maryland, United States, 21204
Contact: Kendra Barton    443-275-1599    kendra.barton@ircclinical.net   
Principal Investigator: Alberto Yataco, MD         
United States, Massachusetts
Boston Clinical Trials Recruiting
Boston, Massachusetts, United States, 02131
Contact: Alexandra Griffith    617-477-4868    Alexandra@bostontrials.com   
Principal Investigator: Robert Bargar, MD         
United States, Michigan
Michigan Head-Pain and Neurological Institute Recruiting
Ann Arbor, Michigan, United States
Contact: Shawn Szalay    734-677-6000 ext 128    sszalay@mhni.com   
Principal Investigator: James R Weintraub, DO         
United States, New Mexico
Albuquerque Clinical Trials, Inc Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Beth Corbin       bcorbin@abct.com   
Principal Investigator: Elizabeth M Bretton, MD, CPI         
United States, North Carolina
Clinical Trials of America, Inc. Recruiting
Hickory, North Carolina, United States, 01845
Contact: Carol Moore    828-322-3222    cmoore@ctamerica.net   
Principal Investigator: Michael DeSantis, MD         
Wake Research Associates Withdrawn
Raleigh, North Carolina, United States
United States, Oklahoma
Lynn Health Science Institute Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Lin Dee Howarth    405-602-1394    lhoworth@lhsi.net   
Principal Investigator: Mark Fisher, MD         
United States, South Carolina
Pain Specialist of Charleston, P.A. Recruiting
Mt. Pleasant, South Carolina, United States
Contact: Alice Buice    843-856-3784    abuice@painchas.com   
Principal Investigator: Edward M Tavel, Jr., MD         
United States, Tennessee
Nashville Neuroscience Group Recruiting
Nashville, Tennessee, United States, 37203
Contact: Teddi Dial    615-284-4680    dialnow@aol.com   
Principal Investigator: Jan Brandes, MD         
Trinity Clinical Research Recruiting
Tullahoma, Tennessee, United States, 37388
Contact: Roberta Adams       Radams.trinityclinicalresearch@gmail.com   
Principal Investigator: Raymond Capps, MD         
United States, Texas
ClinRx Research LLC Recruiting
Plano, Texas, United States, 75080
Contact: Ravi Panchal    214-680-3381    ravi@clinrxresearch.com   
Principal Investigator: Bobby Huynh, MD         
Progressive Clinical Research Recruiting
San Antonio, Texas, United States
Contact: Cynthia Clethen    210-614-5557    cclethen@progclin.com   
Principal Investigator: Theresia L Lee, MD         
Canada, British Columbia
Ronald Collette MD, Inc. Withdrawn
Burnaby, British Columbia, Canada, V5G 1T4
Manna Research Vancouver Recruiting
Vancouver, British Columbia, Canada, V6J 1S3
Contact: Andrea Magwood       andrea.magwood@mannaresearch.com   
Principal Investigator: Melanie Mason, MD         
Canada, Ontario
Schacter Medicine Professional Corporation Withdrawn
London, Ontario, Canada, N5Y 5K7
London Road Diagnostic Clinic and Medical Centre Withdrawn
Sarnia, Ontario, Canada
Manna Research, Inc. Recruiting
Toronto, Ontario, Canada, M9W 4L6
Contact: Kristine Van Sickle    416-740-2895    info@mannaresearch.com   
Principal Investigator: Ben Lasko, MD         
Canada, Quebec
Kells Medical Research Group - Manna Research Recruiting
Pointe-Claire, Quebec, Canada, H9R 4S3
Contact: Dieudonné (Dee) Assimé, D.E.S.S    514-694-9940 ext 164    dassime@kellsmrg.com   
Principal Investigator: Jeannette Janzen, MD         
Sponsors and Collaborators
NeurAxon Inc.
Investigators
Study Director: Thomas Lategan, D.Phil. NeurAxon Inc.
  More Information

No publications provided

Responsible Party: NeurAxon Inc.
ClinicalTrials.gov Identifier: NCT01748877     History of Changes
Other Study ID Numbers: NXN-462-201
Study First Received: December 11, 2012
Last Updated: December 31, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by NeurAxon Inc.:
shingles,
neuropathic pain
post herpetic neuralgia
sleep

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014