Effect of Milnacipran in Chronic Neuropathic Low Back Pain

• ClinicalTrials.gov Identifier: NCT01225068
• Recruitment Status: Completed
• First Posted: October 20, 2010
• Results First Posted: September 25, 2013
• Last Update Posted: January 17, 2014
• Sponsor: Northwestern University
• Collaborators: Forest Laboratories; Shirley Ryan AbilityLab; Best Practice
• Information provided by (Responsible Party): Thomas J. Schnitzer, Northwestern University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Drug: Milnacipran; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: An Exploratory Randomized Placebo Controlled Trial of Milnacipran in Patients With Chronic Neuropathic Low Back Pain
• Study Start Date: October 2010
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: April 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Milnacipran; milnacipran 50 mg bid; can be increased to 100 mg bid	Drug: Milnacipran; 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.; Other Name: Savella
Placebo Comparator: Placebo; Placebo	Drug: Placebo; 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.

Outcome Measures

Primary Outcome Measures :

1. Effect Size of VAS Pain [ Time Frame: 6 weeks from baseline ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Illinois

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Forest Laboratories

Shirley Ryan AbilityLab

Best Practice

Investigators

• Principal Investigator: Thomas J Schnitzer, MD, PhD; Northwestern University

More Information

• Responsible Party: Thomas J. Schnitzer, professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT01225068
• Other Study ID Numbers: STU00036897
• First Posted: October 20, 2010
• Results First Posted: September 25, 2013
• Last Update Posted: January 17, 2014
• Last Verified: December 2013

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations; Milnacipran; Levomilnacipran; Serotonin and Noradrenaline Reuptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Physiological Effects of Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Antidepressive Agents; Psychotropic Drugs