RN624 For Pain Of Post-Herpetic Neuralgia
Condition: Neuralgia, Postherpetic
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: RN624; RN624; Placebo
Intervention description: 50 mcg/kg; 200 mcg/kg; placebo
Intervention MeSH terms: Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: monoclonal antibody

Summary:

      This study will test the efficacy and safety of two doses levels of RN624 versus placebo for
      the relief of pain caused by post-herpetic neuralgia (PHN).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of any race, at least 18 years of age.

          -  Patients must have pain present for more than 3 months after healing of the herpes
             zoster skin rash.

          -  Has a pain score at screening that qualifies.

          -  Completes at least 3 average daily pain diaries during the 3 days prior to
             randomization and has an average pain level that qualifies.

          -  Body Mass Index less than or equal to 39 kg/m2.

          -  If female, is post-menopausal, surgically sterile, or uses adequate contraception
             consisting of 2 forms of birth control, one of which must be barrier method, is not
             lactating, and is not breastfeeding.

          -  Male patients must agree that female spouses/partners will use contraception as
             defined above or be of nonchildbearing potential (post-menopausal or surgically
             sterile).

          -  Patients must be willing and able to comply with scheduled visits, treatment plan,
             laboratory tests, and other study procedures.

          -  Patients must consent in writing to participate in the study.

        Exclusion Criteria:

          -  Patients who cannot discontinue the use of other pain medications during the screening
             period and during the study.

          -  Disqualifying scores on questionnaires.

          -  Other moderate to severe pain from other conditions.

          -  History of allergic or anaphylactic reaction to antibodies.

          -  Use of biologics, including any live vaccines within 3 months of the week prior to the
             baseline visit.

          -  Unable to use acetaminophen.

          -  Disqualify laboratory values, Hepatitis B or C or HIV.

          -  Patients that have had a stroke or TIAs, dementia, epilepsy or seizures, or peripheral
             neuropathy from other conditions.

          -  Significant cardiac disease within 3 months of the study such as angina, heart attack,
             congestive heart failure, and other cardiac problems.

          -  Cancer other than basal cell or squamous cell carcinoma.

          -  Fails a urine test for illegal drugs including prescription drugs without a
             prescription.

          -  Plans for surgery during the study.

          -  History of alcoholism or drug abuse in the past two years.

          -  Surgery for post-herpetic neuralgia.

          -  Any condition that the investigator feels would put the safety of the patient at risk.