Back to resultsEffect of Milnacipran in Chronic Neuropathic Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Milnacipran
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Current Sleep Disorder
Sites / Locations
- Northwestern University Feinberg School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Milnacipran
Placebo
Arm Description
milnacipran 50 mg bid; can be increased to 100 mg bid
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01225068
First Posted
October 13, 2010
Last Updated
December 5, 2013
Sponsor
Northwestern University
Collaborators
Forest Laboratories, Shirley Ryan AbilityLab, Best Practice
1. Study Identification
Unique Protocol Identification Number
NCT01225068
Brief Title
Effect of Milnacipran in Chronic Neuropathic Low Back Pain
Official Title
An Exploratory Randomized Placebo Controlled Trial of Milnacipran in Patients With Chronic Neuropathic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Forest Laboratories, Shirley Ryan AbilityLab, Best Practice
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Milnacipran
Arm Type
Experimental
Arm Description
milnacipran 50 mg bid; can be increased to 100 mg bid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Other Intervention Name(s)
Savella
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect Size of VAS Pain
Description
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.
Time Frame
6 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Current Sleep Disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Schnitzer, MD, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Milnacipran in Chronic Neuropathic Low Back Pain
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