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Sponsors and Collaborators: |
Northwestern University Rehabilitation Institute of Chicago |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00125528 |
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.
Condition | Intervention | Phase |
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Low Back Pain Pain |
Drug: D-cycloserine Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | D-Cycloserine in the Management of Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Pilot Study |
Estimated Enrollment: | 39 |
Arms | Assigned Interventions |
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1: Experimental
D-cycloserine 250 mg bid
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Drug: D-cycloserine
D-cycloserine 250 mg bid
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2: Placebo Comparator
placebo
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Drug: placebo
placebo bid
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thomas J Schnitzer, MD, PhD | 312-503-2315 | tjs@northwestern.edu |
United States, Illinois | |
Northwestern University Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 | |
Rehabilitation Institute of Chicago | |
Chicago, Illinois, United States, 60611 | |
Rehabilitation Institute of Chicago | |
Chicago, Illinois, United States, 60611 |
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 |
Responsible Party: | Northwestern University Feinberg School of Medicine ( Thomas Schnitzer ) |
Study ID Numbers: | A1159 |
Study First Received: | July 29, 2005 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00125528 History of Changes |
Health Authority: | United States: Food and Drug Administration |
neuropathic pain chronic pain low back pain D-cycloserine |
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