Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia
This study is currently recruiting participants.
Verified May 2013 by NeurAxon Inc.
Sponsor:
NeurAxon Inc.
Information provided by (Responsible Party):
NeurAxon Inc.
ClinicalTrials.gov Identifier:
NCT01748877
First received: December 11, 2012
Last updated: May 21, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post Herpetic Neuralgia |
Drug: NXN-462 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by NeurAxon Inc.:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: NXN-462
capsule, 200 mg, bi.d. 28-days
|
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
|
|
Placebo Comparator: Placebo
capsule, b.i.d. 28-days
|
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748877
Contacts
| Contact: Trisha Mortier, CCRA | 760 268 8233 | tmortier@synteract.com |
| Contact: Kyle Iwasaki | 760 476 8867 | kiwasaki@synteract.com |
Locations
| United States, California | |
| Neurovations | Recruiting |
| Napa, California, United States, 94558 | |
| Contact: Whitney Michiels 707-252-9606 whitney@napapaininstitute.com | |
| Principal Investigator: Eric Grigsby, MD, MBA | |
| Northern California Research | Recruiting |
| Sacramento, California, United States, 95821 | |
| Contact: Douglas Young, MD 3840.md@norcare.net | |
| Principal Investigator: Douglas Young, MD | |
| Neurological Research Institute | Recruiting |
| Santa Monica, California, United States | |
| Contact: Jaime Latorre 310-315-1456 | |
| Principal Investigator: David B Kudrow, MD | |
| United States, Florida | |
| Suncoast Clinical Research | Recruiting |
| New Port Richey, Florida, United States | |
| Contact: Krystal Smith 727-849-4131 | |
| Principal Investigator: Lisa M Cohen, DO | |
| Sarasota Pain Medicine Research | Recruiting |
| Sarasota, Florida, United States | |
| Contact: Patricia Dyches 941-917-4536 | |
| Principal Investigator: Donald L Erb, DO | |
| United States, Georgia | |
| Dekalb Neurology Associates | Withdrawn |
| Decatur, Georgia, United States | |
| United States, Iowa | |
| Integrated Clinical Trial Services | Recruiting |
| West Des Moines, Iowa, United States | |
| Contact: Kristine Majors 515-327-4782 | |
| Principal Investigator: Kenneth Pollack, MD | |
| United States, Maryland | |
| IRC Clinics | Recruiting |
| Towson, Maryland, United States, 21204 | |
| Contact: Kendra Barton 443-275-1599 kendra.barton@ircclinical.net | |
| Principal Investigator: Alberto Yataco, MD | |
| United States, Michigan | |
| Michigan Head-Pain and Neurological Institute | Recruiting |
| Ann Arbor, Michigan, United States | |
| Contact: Shawn Szalay 734-677-6000 ext 128 | |
| Principal Investigator: James R Weintraub, DO | |
| United States, North Carolina | |
| Clinical Trials of America, Inc. | Recruiting |
| Hickory, North Carolina, United States, 01845 | |
| Contact: Carol Moore 828-322-3222 | |
| Principal Investigator: Michael DeSantis, MD | |
| Wake Research Associates | Withdrawn |
| Raleigh, North Carolina, United States | |
| United States, South Carolina | |
| Pain Specialist of Charleston, P.A. | Recruiting |
| Mt. Pleasant, South Carolina, United States | |
| Contact: Nathan Morton 843-856-3784 | |
| Principal Investigator: Edward M Tavel, Jr., MD | |
| United States, Texas | |
| Progressive Clinical Research | Recruiting |
| San Antonio, Texas, United States | |
| Contact: Cynthia Clethen 210-614-5557 | |
| Principal Investigator: Theresia L Lee, MD | |
| Canada, British Columbia | |
| Ronald Collette MD, Inc. | Recruiting |
| Burnaby, British Columbia, Canada, V5G 1T4 | |
| Contact: Olga Racanelli 604-434-2270 olgaracanelli@shawcable.com | |
| Principal Investigator: Ronald Collette, MD | |
| Canada, Ontario | |
| Schacter Medicine Professional Corporation | Withdrawn |
| London, Ontario, Canada, N5Y 5K7 | |
| London Road Diagnostic Clinic and Medical Centre | Withdrawn |
| Sarnia, Ontario, Canada | |
| Manna Research, Inc. | Recruiting |
| Toronto, Ontario, Canada, M9W 4L6 | |
| Contact: Kristine Van Sickle 416-740-2895 info@mannaresearch.com | |
| Principal Investigator: Ben Lasko, MD | |
Sponsors and Collaborators
NeurAxon Inc.
Investigators
| Study Director: | Thomas Lategan, D.Phil. | NeurAxon Inc. |
More Information
No publications provided
| Responsible Party: | NeurAxon Inc. |
| ClinicalTrials.gov Identifier: | NCT01748877 History of Changes |
| Other Study ID Numbers: | NXN-462-201 |
| Study First Received: | December 11, 2012 |
| Last Updated: | May 21, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by NeurAxon Inc.:
|
shingles, neuropathic pain post herpetic neuralgia sleep |
Additional relevant MeSH terms:
|
Neuralgia Neuralgia, Postherpetic Pain Neurologic Manifestations |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013