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D-cycloserine in the Management of Chronic Low Back Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00125528
First Posted: August 1, 2005
Last Update Posted: February 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
July 29, 2005
August 1, 2005
February 3, 2015
February 23, 2015
February 9, 2017
July 2012
April 2014   (Final data collection date for primary outcome measure)
Change in Numeric Rating Scale (NRS-11) [ Time Frame: 6 weeks ]
Change in NRS score after 6 weeks of treatment as compared to baseline. The numeric rating scale is an 11-point rating scale wherein participants rated their current lower back pain intensity on a scale from 0 to 10, with 0 meaning no pain and 10 being the worst pain possible. Thus, a larger negative number indicates positive change and a higher efficacy.
Determine efficacy of D-cycloserine in the treatment of chronic low back pain.
Complete list of historical versions of study NCT00125528 on ClinicalTrials.gov Archive Site
McGill Pain Questionnaire (MPQ) [ Time Frame: 6 weeks ]
Change in MPQ score after 6 weeks of treatment as compared to baseline. The MPQ score uses a Pain Rating Index from 0 to 20 where 0 is evidence of no pain and 20 indicates the highest pain possible. A lower score is also indicative of a lower quality of pain. Thus, a larger negative number indicates positive change and therefore higher efficacy.
  • 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.
Not Provided
Not Provided
 
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 (DCS) 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 chronic low back pain. Other aims of this study are to determine the safety of D-cycloserine in the treatment of 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 escalating dose study comparing D-cycloserine twice a day (bid) with placebo bid in patients with chronic low back pain. Subjects meeting inclusion criteria will continue baseline medications and be treated for 12 weeks with study drug: 50 mg bid DCS or matching placebo for the first 4 weeks, then 100mg bid DCS or matching placebo for 4 weeks and finally 200mg bid DCS or matching placebo for 4 weeks. 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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Low Back Pain
  • Pain
  • Drug: D-cycloserine
    D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
  • Drug: placebo
    placebo bid
  • Experimental: 1
    D-cycloserine 50mg bid/100mg bid/200 mg bid
    Intervention: Drug: D-cycloserine
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: placebo
Schnitzer TJ, Torbey S, Herrmann K, Kaushal G, Yeasted R, Vania Apkarian A. A randomized placebo-controlled pilot study of the efficacy and safety of D-cycloserine in people with chronic back pain. Mol Pain. 2016 Nov 15;12. pii: 1744806916678627. Print 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
November 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have a history of low back pain for a minimum of 6 months with or without 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00125528
A1159
No
Not Provided
Not Provided
Thomas J. Schnitzer, Northwestern University
Thomas J. Schnitzer
Not Provided
Principal Investigator: Thomas J Schnitzer, M.D., Ph.D. Northwestern University
Principal Investigator: Vania Apkarian, Ph.D. Northwestern University
Northwestern University
December 2016

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