Civamide Nasal Solution for Postherpetic Neuralgia of the Trigeminal Nerve

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Winston Laboratories
Sponsor:
Information provided by (Responsible Party):
Winston Laboratories
ClinicalTrials.gov Identifier:
NCT01886313
First received: June 20, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Postherpetic Neuralgia
Drug: Civamide Nasal Spray
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Winston Laboratories:

Primary Outcome Measures:
  • Average Daily Pain Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change in Average Daily Pain Score (11-point Numeric Rating Scale [NRS]) from the Baseline Period to the Average Daily Pain Score of the last week (Week 6) of the Treatment Period.


Secondary Outcome Measures:
  • Average Daily Pain Score [ Time Frame: Weeks 1 to 5 ] [ Designated as safety issue: No ]
    Change in Average Daily Pain Score from the Baseline Period to the Average Daily Pain Score of each of weeks 1 - 5 of the study.


Other Outcome Measures:
  • Average Daily Sleep Score [ Time Frame: Weeks 1 to 6 ] [ Designated as safety issue: No ]
    Changes in the secondary efficacy variables from the Baseline Period to the last week of the Treatment Period and other weeks in the study in Average Daily Sleep Score (11-point NRS)

  • Skin Sensitivity [ Time Frame: Weeks 1 to 6 ] [ Designated as safety issue: No ]
    Changes in the secondary efficacy variables from the Baseline Period to the last week of the Treatment Period and other weeks in the study for Skin Sensitivity Assessment (11-point NRS)

  • Subject Global Impression of Change [ Time Frame: Weeks 1 to 6 ] [ Designated as safety issue: No ]
    Changes in the secondary efficacy variables from the Baseline Period to the last week of the Treatment Period and other weeks in the study in Subject Global Impression of Change (7-point Likert scale)

  • Investigator Global Impression of Change [ Time Frame: Weeks 1 to 6 ] [ Designated as safety issue: No ]
    Changes in the secondary efficacy variables from the Baseline Period to the last week of the Treatment Period and other weeks in the study in Investigator Global Impression of Change (7-point Likert scale)

  • Requirement for Acute Medication [ Time Frame: Weeks 1 to 6 ] [ Designated as safety issue: No ]
    Changes in the secondary efficacy variables from the Baseline Period to the last week of the Treatment Period and other weeks in the study in Requirement for Acute Medication


Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Civamide Nasal Spray
Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks
Drug: Civamide Nasal Spray
Placebo Comparator: Placebo Nasal Spray
Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks
Drug: Placebo

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures.
  2. 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.
  3. 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.
  4. Subject has Average Daily Pain Score of 4 or higher on the 11-point numeric rating scale during the 7-Day Baseline Period.
  5. Males or females between 21 to 80 years of age, inclusive.
  6. 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.
  7. The subject agrees not to begin any new concomitant medications during their participation in study.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Presence of a significant nasal disorder.
  4. Subject is immunocompromised (e.g. AIDS, significant oncologic disease, immunocompromising medications, etc.).
  5. Subject received neurolytic or neurosurgical therapy for this or previous episodes of postherpetic neuralgia.
  6. Use of any restricted medication within the given time period prior to the Baseline Period and throughout the study (see Table 1).
  7. Subject has a history of alcohol and/or drug abuse within the past year.
  8. Subject has previously participated in a Civamide study.
  9. Subject has participated in another investigational study or taken another investigational drug within the past 30 days.
  10. Subject has difficulty distinguishing his/her PHN head pain from other types of head pain, such as tension-type headaches.
  11. 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.
  12. 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.)
  13. If, for any other reason, the subject is not deemed to be suitable by the Investigator, they should not be enrolled.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886313

Contacts
Contact: David Kudrow, MD 3102899440

Locations
United States, California
California Medical Clinic for Headache Recruiting
Santa Monica, California, United States, 90404
Contact: David Kudrow, MD    310-289-9440      
Principal Investigator: David Kudrow, MD         
Principal Investigator: Alan Rapoport, MD         
United States, Florida
Sun Rise Medical Recruiting
Lauderdale Lakes, Florida, United States, 33319
Contact: David B Ross, MD    954-915-9991      
Principal Investigator: David B. Ross, MD         
Meridien Research Recruiting
Tampa, Florida, United States, 33606
Contact: Cynthia Huffman, MD    813-873-2303      
Principal Investigator: Cynthia Huffman, MD         
United States, Michigan
Michigan Head Pain and Neurological Institute Recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Joel R. Saper, MD    734-677-6000 ext 140      
Principal Investigator: Joel R. Saper, MD         
Sponsors and Collaborators
Winston Laboratories
  More Information

No publications provided

Responsible Party: Winston Laboratories
ClinicalTrials.gov Identifier: NCT01886313     History of Changes
Other Study ID Numbers: WL-1001-07-01
Study First Received: June 20, 2013
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Winston Laboratories:
Herpes Zoster
Postherpetic Neuralgia
Shingles
Civamide
Zucapsaicin
Neuropeptides
TRPV-1

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 September 18, 2014