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

December 11, 2012
June 18, 2014
January 2013
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01748877 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Post Herpetic Neuralgia
  • 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
  • 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
  • Experimental: NXN-462
    capsule, 200 mg, bi.d. 28-days
    Intervention: Drug: NXN-462
  • Placebo Comparator: Placebo
    capsule, b.i.d. 28-days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
188
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01748877
NXN-462-201
No
NeurAxon Inc.
NeurAxon Inc.
Not Provided
Study Director: Thomas Lategan, D.Phil. NeurAxon Inc.
NeurAxon Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP