Status:
COMPLETED
Effect of Milnacipran in Chronic Neuropathic Low Back Pain
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Forest Laboratories
Shirley Ryan AbilityLab
Conditions:
Low Back Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 treati...
Detailed Description
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, ran...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01225068
Start Date
October 1 2010
End Date
April 1 2012
Last Update
January 17 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611