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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeurAxon Inc.
ClinicalTrials.gov Identifier:
NCT01748877
First received: December 11, 2012
Last updated: June 18, 2014
Last verified: June 2014
  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 ]

Enrollment: 188
Study Start Date: January 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748877

  Hide Study Locations
Locations
United States, Arizona
Premier Research
Phoenix, Arizona, United States, 85027
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Northern California Research
Sacramento, California, United States, 95821
Neurological Research Institute
Santa Monica, California, United States
United States, Florida
Meridien Research
Brooksville, Florida, United States, 34601
FPA Clinical Research
Kissimmee, Florida, United States, 34741
Suncoast Clinical Research
New Port Richey, Florida, United States
Compass Research LLC
Orlando, Florida, United States, 32806
Meridien Research
Tampa, Florida, United States, 33606
United States, Illinois
Medex Healthcare Research, Inc.
Chicago, Illinois, United States, 60602
United States, Iowa
Integrated Clinical Trial Services
West Des Moines, Iowa, United States
United States, Maryland
IRC Clinics
Towson, Maryland, United States, 21204
United States, Massachusetts
Boston Clinical Trials
Boston, Massachusetts, United States, 02131
United States, Michigan
Michigan Head-Pain and Neurological Institute
Ann Arbor, Michigan, United States
United States, New Mexico
Albuquerque Clinical Trials, Inc
Albuquerque, New Mexico, United States, 87102
United States, North Carolina
Clinical Trials of America, Inc.
Hickory, North Carolina, United States, 01845
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
Pain Specialist of Charleston, P.A.
Mt. Pleasant, South Carolina, United States
United States, Tennessee
Nashville Neuroscience Group
Nashville, Tennessee, United States, 37203
Trinity Clinical Research
Tullahoma, Tennessee, United States, 37388
United States, Texas
ClinRx Research LLC
Plano, Texas, United States, 75080
Progressive Clinical Research
San Antonio, Texas, United States
Canada, British Columbia
Manna Research Vancouver
Vancouver, British Columbia, Canada, V6J 1S3
Canada, Ontario
Manna Research, Inc.
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
Kells Medical Research Group - Manna Research
Pointe-Claire, Quebec, Canada, H9R 4S3
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: June 18, 2014
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 August 28, 2014