Clinical trial NCT01748877: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Herpetic Neuralgia
Keywords: shingles,
neuropathic pain
post herpetic neuralgia
sleep
Lead sponsor: NeurAxon Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-13
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline to the last week of treatment in daily pain scores
timeFrame: 4 weeks
Secondary outcomes:
measure: average weekly change in pain score from baseline to the end of the Treatment Period
timeFrame: four weeks
measure: Analysis of percent change from baseline in daily pain score
timeFrame: four weeks
measure: percentage of responders
timeFrame: four weeks
measure: Percentage of subjects with moderate or much improvement at the end of the Treatment Period, according to Patient Global Impression of Change
timeFrame: four weeks
measure: Change from baseline to the end of the Treatment Period in Pain Quality Assessment Scale score
timeFrame: four weeks
measure: Rescue medication consumption
timeFrame: four weeks
measure: Adverse events (AEs), vital signs, and clinical laboratory tests
timeFrame: six weeks
measure: Change from baseline to the end of the Treatment Period in Modified Brief Pain Inventory Short Form score, pain interference subscale
timeFrame: four weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Premier Research
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Kissimmee
country: United States
facility: FPA Clinical Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research LLC
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Chicago
country: United States
facility: Medex Healthcare Research, Inc.
state: Illinois
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services
state: Iowa
city: Towson
country: United States
facility: IRC Clinics
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head-Pain and Neurological Institute
state: Michigan
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc
state: New Mexico
city: Hickory
country: United States
facility: Clinical Trials of America, Inc.
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Mt. Pleasant
country: United States
facility: Pain Specialist of Charleston, P.A.
state: South Carolina
city: Nashville
country: United States
facility: Nashville Neuroscience Group
state: Tennessee
city: Tullahoma
country: United States
facility: Trinity Clinical Research
state: Tennessee
city: Plano
country: United States
facility: ClinRx Research LLC
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Vancouver
country: Canada
facility: Manna Research Vancouver
state: British Columbia
city: Toronto
country: Canada
facility: Manna Research, Inc.
state: Ontario
city: Pointe-Claire
country: Canada
facility: Kells Medical Research Group - Manna Research
state: Quebec
Study officials:
affiliation: NeurAxon Inc.
name: Thomas Lategan, D.Phil.
role: STUDY_DIRECTOR
References: