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

Primary Purpose

Post Herpetic Neuralgia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NXN-462
Placebo
Sponsored by
NeurAxon Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Herpetic Neuralgia focused on measuring shingles,, neuropathic pain, post herpetic neuralgia, sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Premier Research
  • University of Southern California
  • Northern California Research
  • Neurological Research Institute
  • Meridien Research
  • FPA Clinical Research
  • Suncoast Clinical Research
  • Compass Research LLC
  • Meridien Research
  • Medex Healthcare Research, Inc.
  • Integrated Clinical Trial Services
  • IRC Clinics
  • Boston Clinical Trials
  • Michigan Head-Pain and Neurological Institute
  • Albuquerque Clinical Trials, Inc
  • Clinical Trials of America, Inc.
  • Lynn Health Science Institute
  • Pain Specialist of Charleston, P.A.
  • Nashville Neuroscience Group
  • Trinity Clinical Research
  • ClinRx Research LLC
  • Progressive Clinical Research
  • Manna Research Vancouver
  • Manna Research, Inc.
  • Kells Medical Research Group - Manna Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NXN-462

Placebo

Arm Description

capsule, 200 mg, bi.d. 28-days

capsule, b.i.d. 28-days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

average weekly change in pain score from baseline to the end of the Treatment Period
Analysis of percent change from baseline in daily pain score
percentage of responders
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
Change from baseline to the end of the Treatment Period in Pain Quality Assessment Scale score
Rescue medication consumption
Adverse events (AEs), vital signs, and clinical laboratory tests
Change from baseline to the end of the Treatment Period in Modified Brief Pain Inventory Short Form score, pain interference subscale

Full Information

First Posted
December 11, 2012
Last Updated
June 18, 2014
Sponsor
NeurAxon Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01748877
Brief Title
Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeurAxon Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Herpetic Neuralgia
Keywords
shingles,, neuropathic pain, post herpetic neuralgia, sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NXN-462
Arm Type
Experimental
Arm Description
capsule, 200 mg, bi.d. 28-days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
capsule, b.i.d. 28-days
Intervention Type
Drug
Intervention Name(s)
NXN-462
Other Intervention Name(s)
NXN-462 dihydrochloride
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline to the last week of treatment in daily pain scores
Description
Change from baseline to the last week of treatment in daily (24-hour recall) pain scores comparing NXN-462 with placebo
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
average weekly change in pain score from baseline to the end of the Treatment Period
Time Frame
four weeks
Title
Analysis of percent change from baseline in daily pain score
Time Frame
four weeks
Title
percentage of responders
Description
subjects with a ≥30% and ≥50% reduction in pain score from baseline to the last week of treatment
Time Frame
four weeks
Title
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
Title
Change from baseline to the end of the Treatment Period in Pain Quality Assessment Scale score
Time Frame
four weeks
Title
Rescue medication consumption
Time Frame
four weeks
Title
Adverse events (AEs), vital signs, and clinical laboratory tests
Time Frame
six weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Lategan, D.Phil.
Organizational Affiliation
NeurAxon Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Premier Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Neurological Research Institute
City
Santa Monica
State/Province
California
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
FPA Clinical Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Compass Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Integrated Clinical Trial Services
City
West Des Moines
State/Province
Iowa
Country
United States
Facility Name
IRC Clinics
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Michigan Head-Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
01845
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Pain Specialist of Charleston, P.A.
City
Mt. Pleasant
State/Province
South Carolina
Country
United States
Facility Name
Nashville Neuroscience Group
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Trinity Clinical Research
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Facility Name
ClinRx Research LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Manna Research Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6J 1S3
Country
Canada
Facility Name
Manna Research, Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Kells Medical Research Group - Manna Research
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada

12. IPD Sharing Statement

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

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