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Tracking Information | |||||||||||||
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First Received Date † | July 29, 2005 | ||||||||||||
Last Updated Date | November 6, 2008 | ||||||||||||
Start Date † | |||||||||||||
Current Primary Outcome Measures † |
Determine efficacy of D-cycloserine in the treatment of chronic low back pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] | ||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT00125528 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||||||||||
Brief Title † | D-Cycloserine in the Management of Chronic Low Back Pain | ||||||||||||
Official Title † | D-Cycloserine in the Management of Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Pilot Study | ||||||||||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase II | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study | ||||||||||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status † | Not yet recruiting | ||||||||||||
Estimated Enrollment † | 39 | ||||||||||||
Completion Date | |||||||||||||
Primary Completion Date | |||||||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||
Ages | 18 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† |
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Location Countries † | United States | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00125528 | ||||||||||||
Responsible Party | Thomas Schnitzer, Northwestern University Feinberg School of Medicine | ||||||||||||
Secondary IDs †† | |||||||||||||
Study Sponsor † | Northwestern University | ||||||||||||
Collaborators †† | Rehabilitation Institute of Chicago | ||||||||||||
Investigators † |
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Information Provided By | Northwestern University | ||||||||||||
Verification Date | November 2008 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |