Effect of Milnacipran in Chronic Neuropathic Low Back Pain
This study has been completed.
Sponsor:
Northwestern University
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: July 26, 2012
Last verified: July 2012
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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 |
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 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
Secondary Outcome Measures:
- 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 ]
| 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 |
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 |
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
|
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:
- 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
Contacts and Locations
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 |
| Last Updated: | July 26, 2012 |
| 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 June 18, 2013