Dose-Finding Study of REN-1654 in Patients With Post-Herpetic Neuralgia

Exclusion Criteria

• •1. History of peripheral neuropathy or any chronic pain condition other than PHN.
• •2. History of hepatic, cardiovascular, renal, gastrointestinal, hematological, neurological, endocrine (including diabetes), metabolic, pulmonary, immunologic (including HIV) or psychiatric disease that in the opinion of the Investigator would pose a significant safety risk for a subject exposed to an investigational compound such as REN-1654, or could significantly diminish the quality of the efficacy data to be collected in the study.
• •3. History of the following ophthalmic disorders based upon medical review at the screening visit. Subjects will further undergo a screening ophthalmologic assessment. Should any of the following be identified at the screening ophthalmologic examination, the subject will be excluded from the study.
• •* Symptomatic cataract, resulting in any visual impairment (if a subject has been diagnosed with cataract to a degree that the cataract interferes with daily living and/or regarding which an ophthalmologist has recommended cataract surgery);
• •* Other vision-impairing disorders (if a subject is aware of any eye disorder that has impaired vision, such as age-related macular degeneration, lazy eye (amblyopia), double vision or any optic nerve inflammation); presbyopia and other non-pathological visual acuity deficits are not exclusionary;
• •* Herpes zoster ophthalmicus involving the eyeball (if a subject has a history of herpes zoster ophthalmicus causing inflammation of any part of the eye \[conjunctiva, cornea, iris, retina, optic nerve\]; subjects who only had cutaneous herpes zoster involvement of the eyelid without involvement of the eye may be eligible for the study).
• •* Glaucoma or history of ocular hypertension (intraocular pressures greater than 21 mm Hg).
• •4. Cognitive or psychiatric disorders that may diminish compliance with study procedures, including maintenance of a daily pain diary and accurate dosing of study medication.
• •5. Screening liver enzyme results greater than the upper limit of the normal range (a value less than one multiple above the upper limit of normal may be acceptable, if approved by the Sponsor before enrollment of the subject).
• •6. Serum creatinine ≥ 2 mg/dL at screening
• •7. Use of chemotherapy agents or history of cancer, other than non-metastatic skin cancer that has been completely excised, within five years prior to the screening visit.
• •8. History of drug or alcohol abuse within one year prior to screening.
• •9. Use within 2 weeks before start of study investigational compound dosing at baseline and through the end of the study of any investigational compound, any epidural or intrathecal agent, corticosteroid, antiretroviral, etanercept or other anti-TNF-α agent, topical anesthetics, or topical analgesics.