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
  Purpose

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 Intervention Phase
Low Back Pain
Drug: Milnacipran
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory Randomized Placebo Controlled Trial of Milnacipran in Patients With Chronic Neuropathic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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.



Enrollment: 40
Study Start Date: October 2010
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225068

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Forest Laboratories
Rehabilitation Institute of Chicago
Best Practice
Investigators
Principal Investigator: Thomas J Schnitzer, MD, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Thomas J. Schnitzer, professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01225068     History of Changes
Other Study ID Numbers: STU00036897
Study First Received: October 13, 2010
Results First Received: April 17, 2013
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on July 28, 2014