Effect of Milnacipran in Chronic Neuropathic Low Back Pain

This exploratory study aims to evaluate Milnacipran in individuals with chronic neuropathic low back pain. A sample of 40 individuals with chronic low back pain will be enrolled in a double-blind, randomized, parallel group study comparing twice daily administration of milnacipran with placebo (total 100 mg bid-or equivalent placebo dosing). The study will last 6 weeks with subjects being evaluated at the start of the study, at the end of a one-week drug-free period, and at 1, 2 and 6 weeks of treatment. Additionally, subjects will evaluated after treatment has ended. Both standard endpoint outcome measures as well as validated daily self-report measures of pain and activity/disability will be utilized.

Inclusion criteria

• History of low back pain for a minimum of 6 months with radiation to leg or buttocks
• Over 18 years of age and under 70
• Must have a visual analogue scale (VAS) pain score >50mm
• Must be in generally stable health
• Must be willing to abstain from alcohol during the course of the study
• If female, must be post-menopausal, or practicing a highly effective method of contraception or abstinence during the course of the study
• Must be able to read and understand instructions and the questionnaires
• Must be willing to participate in daily data collection requirements via telephone (IVRS)
• Must understand all aspects of the study, and willing to sign an informed consent form in that regard.

Exclusion criteria

• Low back pain associated with systemic signs or symptoms (e.g. fever or chills)
• Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of surgery or tumor in the back
• Involvement in litigation regarding back pain or other disability claim, or receiving workmen's compensation, or seeking either as a result of low back pain.
• Neurological disorder including history of seizures
• Major psychiatric disorder during the past six months
• Active suicidal ideation or recent suicidal behavior
• Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease or malignancy
• Significant renal disease or severe renal insufficiency
• History of, or current, substance abuse/dependence
• Significantly abnormal laboratory values
• Pregnant or lactating any time during the course of the study
• Known sensitivity to Savella or other SNRI
• Glaucoma
• Taking any MAOI, sibutramine, digoxin, tricyclic antidepressants, other SNRI, Opioids.
• Beck Depression Inventory Score >30
• Current Sleep Disorder