Effect of Milnacipran in Chronic Neuropathic Low Back Pain
CompletedPhase 2NCT01225068
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- An Exploratory Randomized Placebo Controlled Trial of Milnacipran in Patients With Chronic Neuropathic Low Back Pain
- Conditions
- Interventions
- Sponsor
- Northwestern University
- Collaborators
- Forest Laboratories; Shirley Ryan AbilityLab; Best Practice
- Start date
- 2010-10
- Primary completion
- 2012-01
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01225068