Post Herpetic NeuralgiaPhase 2NCT01748877
Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia
A Phase 2 study testing NXN-462 in people with Post Herpetic Neuralgia, run by NeurAxon Inc. at 25 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Herpetic Neuralgia
- What is being tested?
- NXN-462
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Jan 2013to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States22 sites
Albuquerque Clinical Trials, Inc
Albuquerque, New Mexico, 87102
Michigan Head-Pain and Neurological Institute
Ann Arbor, Michigan
Boston Clinical Trials
Boston, Massachusetts, 02131
Meridien Research
Brooksville, Florida, 34601
Medex Healthcare Research, Inc.
Chicago, Illinois, 60602
Clinical Trials of America, Inc.
Hickory, North Carolina, 01845
FPA Clinical Research
Kissimmee, Florida, 34741
University of Southern California
Los Angeles, California, 90033
Pain Specialist of Charleston, P.A.
Mt. Pleasant, South Carolina
Nashville Neuroscience Group
Nashville, Tennessee, 37203
Suncoast Clinical Research
New Port Richey, Florida
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Compass Research LLC
Orlando, Florida, 32806
Premier Research
Phoenix, Arizona, 85027
ClinRx Research LLC
Plano, Texas, 75080
Northern California Research
Sacramento, California, 95821
Progressive Clinical Research
San Antonio, Texas
Neurological Research Institute
Santa Monica, California
Meridien Research
Tampa, Florida, 33606
IRC Clinics
Towson, Maryland, 21204
Trinity Clinical Research
Tullahoma, Tennessee, 37388
Integrated Clinical Trial Services
West Des Moines, Iowa
Canada3 sites
Kells Medical Research Group - Manna Research
Pointe-Claire, Quebec, H9R 4S3
Manna Research, Inc.
Toronto, Ontario, M9W 4L6
Manna Research Vancouver
Vancouver, British Columbia, V6J 1S3
About this study
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)
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.
Read the 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.
- Conditions
- Post Herpetic Neuralgia
- Being tested
- NXN-462, Placebo
- Keywords
- shingles,, neuropathic pain, post herpetic neuralgia, sleep
- Medical subject headings
- Neuralgia, Postherpetic, Herpes Zoster, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NXN-462Drug
Also called NXN-462 dihydrochloride
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| NXN-462 | Experimental | capsule, 200 mg, bi.d. 28-days Receives: Drug: NXN-462 |
| Placebo | Placebo comparator | capsule, b.i.d. 28-days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (8)
average weekly change in pain score from baseline to the end of the Treatment Period
Measured: four weeks
Analysis of percent change from baseline in daily pain score
Measured: four weeks
percentage of responders
subjects with a ≥30% and ≥50% reduction in pain score from baseline to the last week of treatment
Measured: four weeks
Percentage of subjects with moderate or much improvement at the end of the Treatment Period, according to Patient Global Impression of Change
Measured: four weeks
Change from baseline to the end of the Treatment Period in Pain Quality Assessment Scale score
Measured: four weeks
Rescue medication consumption
Measured: four weeks
Adverse events (AEs), vital signs, and clinical laboratory tests
Measured: six weeks
Change from baseline to the end of the Treatment Period in Modified Brief Pain Inventory Short Form score, pain interference subscale
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Herpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeurAxon Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Lategan, D.Phil., Study director, NeurAxon Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748877
- Sponsor's protocol ID
- NXN-462-201
- Status last verified
- Jun 2014
- First submitted
- 11 Dec 2012
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01748877
- Acronym / sponsor ID
- NXN-462-201
- Conditions
- Post Herpetic Neuralgia
- Keywords
- shingles,, neuropathic pain, post herpetic neuralgia, sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- NeurAxon Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NXN-462 | Experimental | Drug: NXN-462capsule, 200 mg, bi.d. 28-days |
| Placebo | Placebo comparator | Drug: Placebocapsule, b.i.d. 28-days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NXN-462Also: NXN-462 dihydrochlorideStudy 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. | Drug | NXN-462 |
| PlaceboStudy 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. | Drug | Placebo |
Primary outcome
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
8 secondary outcomes
average weekly change in pain score from baseline to the end of the Treatment Period
Time frame: four weeks
Analysis of percent change from baseline in daily pain score
Time frame: four weeks
percentage of responders
Time frame: four weeks
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
Change from baseline to the end of the Treatment Period in Pain Quality Assessment Scale score
Time frame: four weeks
Rescue medication consumption
Time frame: four weeks
Adverse events (AEs), vital signs, and clinical laboratory tests
Time frame: six weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Lategan, D.Phil. study director
NeurAxon Inc.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NXN-462 in people with Post Herpetic Neuralgia, run by NeurAxon Inc. at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to the last week of treatment in daily pain scores (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2014.