Effect of Milnacipran in Chronic Neuropathic Low Back Pain

This study has been completed.
Sponsor:
Collaborators:
Forest Laboratories
Rehabilitation Institute of Chicago
Best Practice
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier:
NCT01225068
First received: October 13, 2010
Last updated: December 5, 2013
Last verified: December 2013

October 13, 2010
December 5, 2013
October 2010
January 2012   (final data collection date for primary outcome measure)
Effect Size of VAS Pain [ Time Frame: 6 weeks from baseline ] [ Designated as safety issue: No ]

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.

Effect size of pain outcome measures [ Time Frame: 0, 1, 2, 6, and 8 weeks ] [ Designated as safety issue: No ]
Several pain outcome measures in the form of surveys will be used
Complete list of historical versions of study NCT01225068 on ClinicalTrials.gov Archive Site
Not Provided
  • Visual Analog Pain Scale [ Time Frame: 0, 1, 2, 6, and 8 weeks ] [ Designated as safety issue: No ]
  • Brief Pain Index [ Time Frame: 0, 1, 2, 6, and 8 weeks ] [ Designated as safety issue: No ]
  • McGill Pain Questionnaire [ Time Frame: 0, 1, 2, 6, and 8 weeks ] [ Designated as safety issue: No ]
  • Physical Activity measurement [ Time Frame: 0, 1, 2, and 5 weeks ] [ Designated as safety issue: No ]
    Accelerometer data
  • Adverse events [ Time Frame: 0, 1, 2, 6, and 8 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effect of Milnacipran in Chronic Neuropathic Low Back Pain
An Exploratory Randomized Placebo Controlled Trial of Milnacipran in Patients With Chronic Neuropathic Low Back Pain

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Low Back Pain
  • 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
  • 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.
  • Experimental: Milnacipran
    milnacipran 50 mg bid; can be increased to 100 mg bid
    Intervention: Drug: Milnacipran
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01225068
STU00036897
No
Thomas J. Schnitzer, Northwestern University
Northwestern University
  • Forest Laboratories
  • Rehabilitation Institute of Chicago
  • Best Practice
Principal Investigator: Thomas J Schnitzer, MD, PhD Northwestern University
Northwestern University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP