Clinical trial NCT01225068: Effect of Milnacipran in Chronic Neuropathic Low Back Pain
Official title: An Exploratory Randomized Placebo Controlled Trial of Milnacipran in Patients With Chronic Neuropathic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
name: Shirley Ryan AbilityLab
name: Best Practice
First posted: 2010-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 treating chronic low back pain.

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, 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Low back pain associated with systemic signs or symptoms (e.g. fever or chills)
2. Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of surgery or tumor in the back
3. 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.
4. Neurological disorder including history of seizures
5. Major psychiatric disorder during the past six months
6. Active suicidal ideation or recent suicidal behavior
7. Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease or malignancy
8. Significant renal disease or severe renal insufficiency
9. History of, or current, substance abuse/dependence
10. Significantly abnormal laboratory values
11. Pregnant or lactating any time during the course of the study
12. Known sensitivity to Savella or other SNRI
13. Glaucoma
14. Taking any MAOI, sibutramine, digoxin, tricyclic antidepressants, other SNRI, Opioids.
15. Beck Depression Inventory Score \>30
16. Current Sleep Disorder

Primary outcomes:
measure: Effect Size of VAS Pain
timeFrame: 6 weeks from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Thomas J Schnitzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: