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)
1 other identifier
interventional
188
2 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2013
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2012
CompletedFirst Posted
Study publicly available on registry
December 13, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJune 19, 2014
June 1, 2014
1.4 years
December 11, 2012
June 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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
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
- +3 more secondary outcomes
Study Arms (2)
NXN-462
EXPERIMENTALcapsule, 200 mg, bi.d. 28-days
Placebo
PLACEBO COMPARATORcapsule, b.i.d. 28-days
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NeurAxon Inc.lead
Study Sites (25)
Premier Research
Phoenix, Arizona, 85027, United States
University of Southern California
Los Angeles, California, 90033, United States
Northern California Research
Sacramento, California, 95821, United States
Neurological Research Institute
Santa Monica, California, United States
Meridien Research
Brooksville, Florida, 34601, United States
FPA Clinical Research
Kissimmee, Florida, 34741, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Compass Research LLC
Orlando, Florida, 32806, United States
Meridien Research
Tampa, Florida, 33606, United States
Medex Healthcare Research, Inc.
Chicago, Illinois, 60602, United States
Integrated Clinical Trial Services
West Des Moines, Iowa, United States
IRC Clinics
Towson, Maryland, 21204, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Michigan Head-Pain and Neurological Institute
Ann Arbor, Michigan, United States
Albuquerque Clinical Trials, Inc
Albuquerque, New Mexico, 87102, United States
Clinical Trials of America, Inc.
Hickory, North Carolina, 01845, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Pain Specialist of Charleston, P.A.
Mt. Pleasant, South Carolina, United States
Nashville Neuroscience Group
Nashville, Tennessee, 37203, United States
Trinity Clinical Research
Tullahoma, Tennessee, 37388, United States
ClinRx Research LLC
Plano, Texas, 75080, United States
Progressive Clinical Research
San Antonio, Texas, United States
Manna Research Vancouver
Vancouver, British Columbia, V6J 1S3, Canada
Manna Research, Inc.
Toronto, Ontario, M9W 4L6, Canada
Kells Medical Research Group - Manna Research
Pointe-Claire, Quebec, H9R 4S3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thomas Lategan, D.Phil.
NeurAxon Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2012
First Posted
December 13, 2012
Study Start
January 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
June 19, 2014
Record last verified: 2014-06