Phase 2
Completed N=40
Effect of Milnacipran in Chronic Neuropathic Low Back Pain
Source: ClinicalTrials.gov NCT01225068 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Sep 2013
Primary outcomePrimary: Effect Size of VAS Pain — 24.8; 31.3 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect Size of VAS Pain |
24.8; 31.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01225068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.