Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 in Lumbar Radiculopathy (Sciatica)

Inclusion Criteria

• •1. Subjects must have a history of persistent pain secondary to unilateral monoradiculopathy present for a minimum of 3 months prior to the study, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.
• •2. Males or females between 18 and 70 years of age, inclusive. Females who are pregnant or breastfeeding will be excluded from the trial.
• •3. Subjects must be in generally good health, either using no medication or using a stabilized medication regimen for chronic and well-controlled conditions such as hypertension, allergies, stable endocrinopathies (e.g. hypothyroidism), etc. Subjects with other active diseases will be reviewed on a case-by-case basis by the principal investigator.
• •4. No concomitant therapy with any medication that is a known significant inhibitor or inducer of CYP450 2D6 and CYP3A4, at the discretion of the PI.
• •5. Normal or clinically insignificant screening laboratory tests:
• •* Serum BUN, creatinine, bicarbonate, calcium, chloride, potassium, sodium, lactate dehydrogenase, inorganic phosphate, total protein, glucose, albumin, and uric acid. WBC, absolute neutrophil count, hemoglobin, hematocrit, and platelets. SGOT (AST), SGPT (ALT), total bilirubin, alkaline phosphatase, TSH/T4, urinalysis, and urine toxicology screen.
• •* Electrocardiogram (12-lead). Any significant laboratory abnormalities will be reviewed by the principal investigator prior to inclusion of the subject in the study.
• •6. Willingness to restrict analgesic therapy during inpatient admission days to the allowed rescue analgesic agent permitted by the study (acetaminophen).
• •7. Subjects must have normal cognitive function and communicative ability in the English language.
• •8. Subjects must be able to provide meaningful written informed consent.
• •9. Subjects must be able to maintain complete required questionnaires, and must be able to fulfill all other conditions of the protocol.