Effect of Milnacipran in Chronic Neuropathic Low Back Pain

NCT ID: NCT01225068

Last Updated: 2014-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-04-30

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.

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Milnacipran

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

Group Type: EXPERIMENTAL

Milnacipran

Intervention Type: 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.

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Savella

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: collaborator

Best Practice

UNKNOWN

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Thomas J. Schnitzer

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas J Schnitzer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00036897

Identifier Type: -

Identifier Source: org_study_id