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Completed

NCT Number: NCT01748877

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

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.

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Key information

Conditions

Post Herpetic Neuralgia DNA Virus Infections Herpes Zoster Herpesviridae Infections Infections Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Varicella Zoster Virus Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Manna Research Vancouver, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NXN-462

Drug

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 names: NXN-462 dihydrochloride

Placebo

Drug

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 outcomes

  1. Change from baseline to the last week of treatment in daily pain scores

    Time frame: 4 weeks

    Change from baseline to the last week of treatment in daily (24-hour recall) pain scores comparing NXN-462 with placebo

Secondary outcomes

  1. average weekly change in pain score from baseline to the end of the Treatment Period

    Time frame: four weeks

  2. Analysis of percent change from baseline in daily pain score

    Time frame: four weeks

  3. percentage of responders

    Time frame: four weeks

    subjects with a ≥30% and ≥50% reduction in pain score from baseline to the last week of treatment

  4. 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

  5. Change from baseline to the end of the Treatment Period in Pain Quality Assessment Scale score

    Time frame: four weeks

  6. Rescue medication consumption

    Time frame: four weeks

  7. Adverse events (AEs), vital signs, and clinical laboratory tests

    Time frame: six weeks

  8. 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

Sponsors and collaborators

Lead sponsor

NeurAxon Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2012
Registry last updated
Jun 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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