Effect of Milnacipran in Chronic Neuropathic Low Back Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Low Back Pain

In brief

Low back pain is a public health problem affecting between 70-85% of adults at some time in their life. This study is being done to study the safety and effectiveness of the drug Milnacipran in treating chronic low back pain.

Key facts

Study ID

NCT01225068

Run by

Northwestern University

People needed

40

Starts

2010-10-01

Expected to finish

2012-04-01

Last updated by the study team

2014-01-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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