Effect of Milnacipran in Chronic Neuropathic Low Back Pain

NCT01225068 | Completed Phase 2 Results

• 1 other identifier: STU00036897
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Milnacipran

EXPERIMENTAL

milnacipran 50 mg bid; can be increased to 100 mg bid

Drug: Milnacipran

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Milnacipran DRUG

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.

Also known as: Savella

Milnacipran

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Forest Laboratories: collaborator
• Shirley Ryan AbilityLab: collaborator
• Best Practice: collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Thomas J Schnitzer
• Organization: Northwestern University Feinberg School of Medicine

tjs@northwestern.edu

3125032315

Study Officials

• Thomas J Schnitzer, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 20, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 17, 2014
• Results First Posted: September 25, 2013

Record last verified: 2013-12

Locations

US (1)