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Clinical Trial Name - D-Cycloserine in the Management of Chronic Low Back Pain

 
Original Study ID : A1159
NCT ID : NCT00125528
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.

Source : Northwestern University
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.

Overall Status : Not yet recruiting
Official Title : Phase 2
Phase : Interventional
Study Design : Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Enrollment : 39
Verification Date : November 2008
First Received Date : July 29, 2005
Trial Eligibility
Criteria :
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.
Gender : Both
Minimum Age : 18 Years
Maximum Age : N/A
Healthy Volunteers : No
Facilities
Facility Name : Northwestern University Feinberg School of Medicine
City : Chicago
State : Illinois
Zip Code : 60611
Country : United States
Facility Name : Rehabilitation Institute of Chicago
City : Chicago
State : Illinois
Zip Code : 60611
Country : United States
Facility Name : Rehabilitation Institute of Chicago
City : Chicago
State : Illinois
Zip Code : 60611
Country : United States
OutComes
Primary OutComes
Measure : Determine efficacy of D-cycloserine in the treatment of chronic low back pain
Time Frame : 4 weeks
Safety issue : No
Secondary OutComes
Measure : Determine safety profile of D-cycloserine in the treatment of neuropathic chronic low back pain
Time Frame : 8 weeks
Safety issue : No
Measure : Evaluate response characteristics of various outcome measures to D-cycloserine treatment in these subjects
Time Frame : 8 weeks
Safety issue : No
Interventions
Type : Drug
Name : D-cycloserine
Description : D-cycloserine 250 mg bid
Type : Drug
Name : placebo
Description : placebo bid
 
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