Effect of Milnacipran in Chronic Neuropathic Low Back Pain

Low Back Pain Clinical Trial

Official title:

An Exploratory Randomized Placebo Controlled Trial of Milnacipran in Patients With Chronic Neuropathic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225068
• Other study ID #: STU00036897
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2010
• Last updated: December 5, 2013
• Start date: October 2010
• Est. completion date: April 2012

Study information

• Verified date: December 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	Best Practice, Forest Laboratories, Rehabilitation Institute of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No