Effect of Milnacipran in Chronic Neuropathic Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Exploratory Randomized Placebo Controlled Trial of Milnacipran in Patients With Chronic Neuropathic Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Milnacipran
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milnacipran<br>milnacipran 50 mg bid; can be increased to 100 mg bid | Drug: Milnacipran<br>* Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.<br>* Other names: Savella;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* 2 matching pills per day for 6 weeks. Option to increase dose after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect Size of VAS Pain | Effect size (ES) calculation for VAS pain between milnacipran and placebo groups' ES is dimensionless; Visual analogue scale (VAS) measured pain in integral units from 0 (low end) to 100 (high end); ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (determined at baseline and 6 weeks here) divided by the pooled standard deviation. This is the primary outcome measure. | 6 weeks from baseline |