RN624 For Pain Of Post-Herpetic Neuralgia

A PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP, PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF RN624 IN ADULT PATIENTS WITH POST-HERPETIC NEURALGIA

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).

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.