D-cycloserine in the Management of Chronic Low Back Pain - Full Text View

Sponsor:	Thomas J. Schnitzer
Information provided by (Responsible Party):	Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier:	NCT00125528

Purpose

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
Low Back Pain Pain	Drug: D-cycloserine Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	D-Cycloserine in the Management of Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Cycloserine

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Determine efficacy of D-cycloserine in the treatment of chronic low back pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine safety profile of D-cycloserine in the treatment of neuropathic chronic low back pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Evaluate response characteristics of various outcome measures to D-cycloserine treatment in these subjects [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	39
Study Start Date:	March 2012
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 D-cycloserine 50mg bid/100mg bid/200 mg bid	Drug: D-cycloserine D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
Placebo Comparator: 2 placebo	Drug: placebo placebo bid

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125528

Contacts

Contact: Thomas J Schnitzer, MD, PhD

312-503-2315

tjs@northwestern.edu

Locations

United States, Illinois
Northwestern University Feinberg School of Medicine	Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Thomas J Schnitzer, M.D., Ph.D 312-503-2315 tjs@northwestern.edu
Principal Investigator: Thomas J Schnitzer, M.D., Ph.D

Sponsors and Collaborators

Thomas J. Schnitzer

Investigators

Principal Investigator:	Thomas J Schnitzer, M.D., Ph.D.	Northwestern University
Principal Investigator:	Vania Apkarian, Ph.D.	Northwestern University

More Information

No publications provided

Responsible Party:	Thomas J. Schnitzer, professor, Northwestern University
ClinicalTrials.gov Identifier:	NCT00125528 History of Changes
Other Study ID Numbers:	A1159
Study First Received:	July 29, 2005
Last Updated:	January 4, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Northwestern University:

neuropathic pain
chronic pain
low back pain
D-cycloserine

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012