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D-Cycloserine in the Management of Chronic Low Back Pain
This study is not yet open for participant recruitment.
Study NCT00125528   Information provided by Northwestern University
First Received: July 29, 2005   Last Updated: November 6, 2008   History of Changes
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July 29, 2005
November 6, 2008
 
Determine efficacy of D-cycloserine in the treatment of chronic low back pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00125528 on ClinicalTrials.gov Archive Site
  • Determine safety profile of D-cycloserine in the treatment of neuropathic chronic low back pain [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Evaluate response characteristics of various outcome measures to D-cycloserine treatment in these subjects [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Determine safety profile of D-cycloserine in the treatment of neuropathic chronic low back pain.
  • Evaluate response characteristics of various outcome measures to D-cycloserine treatment in these subjects.
 
D-Cycloserine in the Management of Chronic Low Back Pain
D-Cycloserine in the Management of Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

Pre-clinical studies in rats suggest that D-cycloserine is effective in the management of chronic neuropathic pain. This pilot study will attempt to determine the effect of D-cycloserine in the treatment of neuropathic chronic low back pain. Other aims of this study are to determine the safety of D-cycloserine in the treatment of neuropathic chronic low back pain and to determine which pain measurement scales are best at measuring the efficacy of treatment.

Human brain imaging studies indicate that the medial prefrontal cortex activity can predict more than 80% of the variance of chronic back pain intensity.

Therefore, the investigators have hypothesized that modulation of brain activity at this site should result in analgesia. D-cycloserine has been shown to potentiate conditioned fear extinction. Based on this the investigators hypothesize that chronic neuropathic pain (back pain with radiculopathy) is partially mediated or potentiated by decreased ability to extinguish the pain memory, which the investigators hypothesize to be mediated through reward/aversion brain circuitry, and specifically through medial prefrontal cortex. They have tested this idea in pre-clinical studies and demonstrated that rats with neuropathic pain show analgesia over the long-term when treated with D-cycloserine. In humans with chronic back pain, the investigators hypothesize that D-cycloserine will enhance extinction of back pain which in turn should result in reduced emotional relevance of the pain, that is reduced suffering. It is quite possible that the overall intensity of the back pain will be unaffected, however, the associated suffering will be significantly attenuated.

This will be a double-blind, randomized, parallel group study comparing D-cycloserine at 250mg twice a day (bid) with placebo bid in patients with neuropathic chronic low back pain. Subjects meeting inclusion criteria will continue baseline medications and be treated for 4 weeks with study drug, followed by a 2 week blinded placebo treatment period and a subsequent 4 weeks of treatment with the same study drug as the initial treatment period.

Assessments of efficacy and safety will be undertaken every 2 weeks using standard, validated instruments to evaluate change in pain, function, quality of life and adverse events.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
  • Low Back Pain
  • Pain
  • Drug: D-cycloserine
  • Drug: placebo
  • Experimental: D-cycloserine 250 mg bid
  • Placebo Comparator: placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
39
 
 

Inclusion Criteria:

  • Must have a history of low back pain for a minimum of 6 months with radiation of pain to leg or buttocks.
  • Must be 18 years of age.
  • Must have a visual analogue scale (VAS) pain score >50 mm
  • Must be in generally stable health
  • Must be willing to abstain from drinking alcohol during the course of the study.
  • If female, must be post-menopausal for at least one year or practicing an accepted, highly effective method of contraception or abstinence and plan to continue either during the course of the study.
  • Must be able and willing to read and understand instructions as well as questionnaires
  • Must sign an informed consent document after complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate.

Exclusion Criteria:

  • Low back pain associated with any systemic signs or symptoms, e.g., fever, chills.
  • Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of surgery or tumor in the back.
  • Involvement in litigation regarding their back pain or have a disability claim or are receiving workman's compensation or seeking either as a result of their low back pain
  • Neurologic disorder, including history of seizures
  • Major psychiatric disorder during the past 6 months
  • Moderate or severe depression as determined by the Beck Depression Inventory or any active suicidal ideation
  • 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 including alcohol
  • Significantly abnormal laboratory values
  • Pregnant or lactating at any time during the course of the study
  • Known sensitivity to D-cycloserine
  • Currently taking any of the following medications: ethionamide, dilantin, isoniazid (INH), pyridoxine (vitamin B6)
  • In the judgment of the investigator, unable or unwilling to follow the protocol and instructions
  • Any change in medication for back pain in the last 30 days.
Both
18 Years and older
No
Contact: Thomas J Schnitzer, MD, PhD 312-503-2315 tjs@northwestern.edu
United States
 
 
NCT00125528
Thomas Schnitzer, Northwestern University Feinberg School of Medicine
 
Northwestern University
Rehabilitation Institute of Chicago
Principal Investigator: Thomas J Schnitzer, M.D., Ph.D. Northwestern University
Principal Investigator: Vania Apkarian, Ph.D. Northwestern University
Principal Investigator: Norman Harden, M.D. Rehabilitation Institute of Chicago
Northwestern University
November 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.