D-cycloserine in the Management of Chronic Low Back Pain

NCT00125528 | Completed Phase 2 Results

• 1 other identifier: A1159
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Pain

Keywords

chronic pain; low back pain; D-cycloserine

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Rating Scale (NRS-11)

  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.

  6 weeks

Secondary Outcomes (1)

• McGill Pain Questionnaire (MPQ)

  6 weeks

Study Arms (2)

1

EXPERIMENTAL

D-cycloserine 50mg bid/100mg bid/200 mg bid

Drug: D-cycloserine

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

D-cycloserine DRUG

D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid

1

placebo DRUG

placebo bid

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas J. Schnitzer: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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;12:1744806916678627. doi: 10.1177/1744806916678627. Print 2016.

  PMID: 27852965 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Low Back Pain; Pain; Chronic Pain

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

It is not clear whether observed effects are due to escalating dose or duration of D-cycloserine use. A larger population and longer duration of treatment would be needed to determine this.

Results Point of Contact

• Title: Dr. Thomas Schnitzer
• Organization: Northwestern Universiyt

tjs@northwestern.edu

312-503-2315

Study Officials

• Thomas J Schnitzer, M.D., Ph.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Vania Apkarian, Ph.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 29, 2005
• First Posted: August 1, 2005
• Study Start: July 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 9, 2017
• Results First Posted: February 23, 2015

Record last verified: 2016-12

Locations

US (1)