Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia
NCT ID: NCT01748877
Last Updated: 2014-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
188 participants
INTERVENTIONAL
2013-01-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NXN-462
capsule, 200 mg, bi.d. 28-days
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
capsule, b.i.d. 28-days
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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NeurAxon Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Lategan, D.Phil.
Role: STUDY_DIRECTOR
NeurAxon Inc.
Locations
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Premier Research
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
Northern California Research
Sacramento, California, United States
Neurological Research Institute
Santa Monica, California, United States
Meridien Research
Brooksville, Florida, United States
FPA Clinical Research
Kissimmee, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Compass Research LLC
Orlando, Florida, United States
Meridien Research
Tampa, Florida, United States
Medex Healthcare Research, Inc.
Chicago, Illinois, United States
Integrated Clinical Trial Services
West Des Moines, Iowa, United States
IRC Clinics
Towson, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Michigan Head-Pain and Neurological Institute
Ann Arbor, Michigan, United States
Albuquerque Clinical Trials, Inc
Albuquerque, New Mexico, United States
Clinical Trials of America, Inc.
Hickory, North Carolina, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Pain Specialist of Charleston, P.A.
Mt. Pleasant, South Carolina, United States
Nashville Neuroscience Group
Nashville, Tennessee, United States
Trinity Clinical Research
Tullahoma, Tennessee, United States
ClinRx Research LLC
Plano, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Manna Research Vancouver
Vancouver, British Columbia, Canada
Manna Research, Inc.
Toronto, Ontario, Canada
Kells Medical Research Group - Manna Research
Pointe-Claire, Quebec, Canada
Countries
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Other Identifiers
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NXN-462-201
Identifier Type: -
Identifier Source: org_study_id
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