Postherpetic NeuralgiaPhase 2NCT01886313
Civamide Nasal Solution for Postherpetic Neuralgia of the Trigeminal Nerve
A Phase 2 study testing Civamide Nasal Spray in people with Postherpetic Neuralgia, run by Winston Laboratories at 5 sites in United States.
Trial summary
Herpes zoster (commonly referred to as "shingles") results from the reactivation of the varicella-zoster virus acquired during a primary infection, usually chickenpox. The virus lays dormant in the cells of the nerves until activated. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- Civamide Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2014to Apr 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures.
- Subject is in generally good health other than a history of postherpetic neuralgia, determined by pre-study medical evaluation (medical history, physical examination including examination of the treatment area, and vital signs) and without evidence of underlying unstable acute or chronic systemic disease, e.g. diabetes.
- Subject has experienced on average, moderate to severe chronic postherpetic neuralgia restricted to the distribution of the affected trigeminal nerve or its divisions for at least 12 months after healing of a herpes zoster skin rash.
- Subject has Average Daily Pain Score of 4 or higher on the 11-point numeric rating scale during the 7-Day Baseline Period.
- Males or females between 21 to 80 years of age, inclusive.
- Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, or intrauterine device) throughout the study or females of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year). A negative urine pregnancy test must be confirmed at screening for all female subjects who are not surgically sterile.
- The subject agrees not to begin any new concomitant medications during their participation in study.
Who cannot join
- Subject has a history of frequent headache or other painful conditions, other than that associated with PHN, within the past 30 days that has required or is expected to require the additional use (beyond stable daily doses) of prescription or over the counter pain relief medication, such as non-steroidal anti-inflammatory agents, including COX-2 inhibitors, systemic opiates or derivatives, or acetaminophen more than 2 times per week during the study. Concurrent medications and stable dose requirements are listed in Table 3.
- Clinical, historical or previous laboratory evidence of significant cardiovascular, renal, gastrointestinal, pulmonary, hepatic, endocrine, neurological, psychological, or other systemic disease that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk to the subject.
- Presence of a significant nasal disorder.
- Subject is immunocompromised (e.g. AIDS, significant oncologic disease, immunocompromising medications, etc.).
- Subject received neurolytic or neurosurgical therapy for this or previous episodes of postherpetic neuralgia.
- Use of any restricted medication within the given time period prior to the Baseline Period and throughout the study (see Table 1).
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- Subject has a history of alcohol and/or drug abuse within the past year.
- Subject has previously participated in a Civamide study.
- Subject has participated in another investigational study or taken another investigational drug within the past 30 days.
- Subject has difficulty distinguishing his/her PHN head pain from other types of head pain, such as tension-type headaches.
- Known hypersensitivity to or contraindication to the use of Civamide (zucapsaicin), capsaicin (Zuacta®, Zostrix®, Zostrix-HP®, Axsain®, or related products) or to any excipient of the clinical formulation.
- Initiation of a medication, discontinuation of a medication or change in regimen of existing medication(s) or therapies less than the required period of stable dosing prior to entering the Baseline Period. (See table 2.)
- If, for any other reason, the subject is not deemed to be suitable by the Investigator, they should not be enrolled.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104
Furture Search Trials of Neurology, LP
Austin, Texas, 78731
Sun Rise Medical
Lauderdale Lakes, Florida, 33319
California Medical Clinic for Headache
Santa Monica, California, 90404
Meridien Research
Tampa, Florida, 33606
About this study
Official title: A DOUBLE BLIND, RANDOMIZED, VEHICLE-CONTROLLED, PARALLEL-GROUP EVALUATION OF CIVAMIDE (ZUCAPSAICIN) 0.01% AND VEHICLE NASAL SPRAYS IN THE TREATMENT OF POSTHERPETIC NEURALGIA OF THE TRIGEMINAL NERVE
Herpes zoster (commonly referred to as "shingles") results from the reactivation of the varicella-zoster virus acquired during a primary infection, usually chickenpox. The virus lays dormant in the cells of the nerves until activated. Once activated, patients develop a characteristic red blistering rash which crusts and heals in 2 - 4 weeks. Postherpetic neuralgia (PHN), the term for pain persisting after the herpes zoster (HZ) eruption heals, is the most common and most feared complication of herpes zoster infection. The drug, Civamide is thought to desensitize the nerves and decrease the pain of PHN. This is the pharmacologic rationale for its use in the nose in postherpetic neuralgia of the trigeminal nerve, a nerve that is in the nose and transmits pain from the face. The objective of this study is to evaluate the safety and efficacy of intranasally administered Civamide (0.01%) for the treatment of moderate to severe daily pain associated with postherpetic neuralgia of the trigeminal nerve. Neuropathic pain must have persisted for ≥ 12 months.
- Conditions
- Postherpetic Neuralgia
- Being tested
- Civamide Nasal Spray, Placebo
- Keywords
- Herpes Zoster, Postherpetic Neuralgia, Shingles, Civamide, Zucapsaicin, Neuropeptides, TRPV-1
- Medical subject headings
- Neuralgia, Postherpetic, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Civamide Nasal SprayDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Civamide Nasal Spray | Active comparator | Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks Receives: Drug: Civamide Nasal Spray |
| Placebo Nasal Spray | Placebo comparator | Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Pain Score
The change in the Average Daily Pain Score (11-point Numeric Rating Scale (NRS)) from the Baseline Period to the Average Daily Pain Score of the last week of the Treatment Period. The minimum score is 0 and the maximum score is 10. A score of 0 indicates no pain while a score of 10 indicates worst possible pain.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postherpetic 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winston Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886313
- Sponsor's protocol ID
- WL-1001-07-01
- Status last verified
- Jan 2017
- First submitted
- 20 Jun 2013
- Last updated
- 1 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A DOUBLE BLIND, RANDOMIZED, VEHICLE-CONTROLLED, PARALLEL-GROUP EVALUATION OF CIVAMIDE (ZUCAPSAICIN) 0.01% AND VEHICLE NASAL SPRAYS IN THE TREATMENT OF POSTHERPETIC NEURALGIA OF THE TRIGEMINAL NERVE
- ClinicalTrials.gov ID
- NCT01886313
- Acronym / sponsor ID
- WL-1001-07-01
- Conditions
- Postherpetic Neuralgia
- Keywords
- Herpes Zoster, Postherpetic Neuralgia, Shingles, Civamide, Zucapsaicin, Neuropeptides, TRPV-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Winston LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Posted 1 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Herpes zoster (commonly referred to as "shingles") results from the reactivation of the varicella-zoster virus acquired during a primary infection, usually chickenpox. The virus lays dormant in the cells of the nerves until activated. Once activated, patients develop a characteristic red blistering rash which crusts and heals in 2 - 4 weeks. Postherpetic neuralgia (PHN), the term for pain persisting after the herpes zoster (HZ) eruption heals, is the most common and most feared complication of herpes zoster infection. The drug, Civamide is thought to desensitize the nerves and decrease the pain of PHN. This is the pharmacologic rationale for its use in the nose in postherpetic neuralgia of the trigeminal nerve, a nerve that is in the nose and transmits pain from the face. The objective of this study is to evaluate the safety and efficacy of intranasally administered Civamide (0.01%) for the treatment of moderate to severe daily pain associated with postherpetic neuralgia of the trigeminal nerve. Neuropathic pain must have persisted for ≥ 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Civamide Nasal Spray | Active comparator | Drug: Civamide Nasal SprayCivamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks |
| Placebo Nasal Spray | Placebo comparator | Drug: PlaceboPlacebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures.
- Subject is in generally good health other than a history of postherpetic neuralgia, determined by pre-study medical evaluation (medical history, physical examination including examination of the treatment area, and vital signs) and without evidence of underlying unstable acute or chronic systemic disease, e.g. diabetes.
- Subject has experienced on average, moderate to severe chronic postherpetic neuralgia restricted to the distribution of the affected trigeminal nerve or its divisions for at least 12 months after healing of a herpes zoster skin rash.
- Subject has Average Daily Pain Score of 4 or higher on the 11-point numeric rating scale during the 7-Day Baseline Period.
- Males or females between 21 to 80 years of age, inclusive.
Key exclusion criteria (13 listed)
- Subject has a history of frequent headache or other painful conditions, other than that associated with PHN, within the past 30 days that has required or is expected to require the additional use (beyond stable daily doses) of prescription or over the counter pain relief medication, such as non-steroidal anti-inflammatory agents, including COX-2 inhibitors, systemic opiates or derivatives, or acetaminophen more than 2 times per week during the study. Concurrent medications and stable dose requirements are listed in Table 3.
- Clinical, historical or previous laboratory evidence of significant cardiovascular, renal, gastrointestinal, pulmonary, hepatic, endocrine, neurological, psychological, or other systemic disease that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk to the subject.
- Presence of a significant nasal disorder.
- Subject is immunocompromised (e.g. AIDS, significant oncologic disease, immunocompromising medications, etc.).
- Subject received neurolytic or neurosurgical therapy for this or previous episodes of postherpetic neuralgia.
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 |
|---|---|---|
| Civamide Nasal Spray | Drug | Civamide Nasal Spray |
| Placebo | Drug | Placebo Nasal Spray |
Primary outcome
Average Daily Pain Score
Time frame: 6 weeks
The change in the Average Daily Pain Score (11-point Numeric Rating Scale (NRS)) from the Baseline Period to the Average Daily Pain Score of the last week of the Treatment Period. The minimum score is 0 and the maximum score is 10. A score of 0 indicates no pain while a score of 10 indicates worst possible pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Civamide Nasal Spray in people with Postherpetic Neuralgia, run by Winston Laboratories at 5 sites in United States.
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 7 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: stopped early, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Yes. Results are posted in the registry (first posted 1 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Daily Pain Score (time frame: 6 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 1 Mar 2017.