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

Post Herpetic Neuralgia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748877
• Other study ID #: NXN-462-201
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2012
• Last updated: June 18, 2014
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: NeurAxon Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Post Herpetic Neuralgia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Kells Medical Research Group - Manna Research	Pointe-Claire	Quebec
Canada	Manna Research, Inc.	Toronto	Ontario
Canada	Manna Research Vancouver	Vancouver	British Columbia
United States	Albuquerque Clinical Trials, Inc	Albuquerque	New Mexico
United States	Michigan Head-Pain and Neurological Institute	Ann Arbor	Michigan
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Meridien Research	Brooksville	Florida
United States	Medex Healthcare Research, Inc.	Chicago	Illinois
United States	Clinical Trials of America, Inc.	Hickory	North Carolina
United States	FPA Clinical Research	Kissimmee	Florida
United States	University of Southern California	Los Angeles	California
United States	Pain Specialist of Charleston, P.A.	Mt. Pleasant	South Carolina
United States	Nashville Neuroscience Group	Nashville	Tennessee
United States	Suncoast Clinical Research	New Port Richey	Florida
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Compass Research LLC	Orlando	Florida
United States	Premier Research	Phoenix	Arizona
United States	ClinRx Research LLC	Plano	Texas
United States	Northern California Research	Sacramento	California
United States	Progressive Clinical Research	San Antonio	Texas
United States	Neurological Research Institute	Santa Monica	California
United States	Meridien Research	Tampa	Florida
United States	IRC Clinics	Towson	Maryland
United States	Trinity Clinical Research	Tullahoma	Tennessee
United States	Integrated Clinical Trial Services	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
NeurAxon Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	average weekly change in pain score from baseline to the end of the Treatment Period		four weeks	No
Secondary	Analysis of percent change from baseline in daily pain score		four weeks	No
Secondary	percentage of responders	subjects with a =30% and =50% reduction in pain score from baseline to the last week of treatment	four weeks	No
Secondary	Percentage of subjects with moderate or much improvement at the end of the Treatment Period, according to Patient Global Impression of Change		four weeks	No
Secondary	Change from baseline to the end of the Treatment Period in Pain Quality Assessment Scale score		four weeks	No
Secondary	Rescue medication consumption		four weeks	No
Secondary	Adverse events (AEs), vital signs, and clinical laboratory tests		six weeks	Yes
Secondary	Change from baseline to the end of the Treatment Period in Modified Brief Pain Inventory Short Form score, pain interference subscale		four weeks	No