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D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain

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ClinicalTrials.gov Identifier: NCT03535688
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University

Tracking Information
First Submitted Date  ICMJE April 3, 2018
First Posted Date  ICMJE May 24, 2018
Last Update Posted Date January 7, 2019
Actual Study Start Date  ICMJE March 30, 2018
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
Change in Numeric Rating Scale (NRS) pain score [ Time Frame: 12 weeks ]
Mean pain levels will be assessed at study baseline and compared to mean pain levels at Week 12 (study efficacy endpoint). Pain will be assessed using an 11-point NRS scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03535688 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • Gender (male/female) [ Time Frame: 12 weeks ]
    Assess the effect of gender on magnitude of pain response
  • Brain biomarkers (MRI) [ Time Frame: 12 weeks ]
    Evaluate interaction between the primary endpoint and specified brain biomarkers, with particular attention to corticostriatal connectivity. Whole-brain exploratory analyses will also be used to identify both brain predictors or treatment response and brain reorganization in response to treatment.
  • McGill Pain Questionnaire (MPQ) [ Time Frame: 12 weeks ]
    A 17-item self-reported measure assessing both the quality and intensity of subjective pain.
  • painDETECT Questionnaire (PDQ) [ Time Frame: 12 weeks ]
    A 14-item self-reported measure assessing qualities for pain of neuropathic origin to distinguish pain severity.
  • Beck Depression Inventory (BDI) [ Time Frame: 12 week ]
    A 21-item self-report rating inventory that measures characteristic attitudes and symptoms of depression.
  • Positive and Negative Affect Schedule (PANAS) [ Time Frame: 12 weeks ]
    A self-report questionnaire consisting of two 10-item (5-point) scales to measure both positive and negative affects of pain.
  • Pain Catastrophizing Scale (PCS) [ Time Frame: 12 weeks ]
    A 13-item scale assessing the degree of catastrophic cognitions in the sensation of pain. The scale ranges from 1 (not at all) to 4 (always).
  • Multidimensional Assessment of Interoceptive Awareness (MAIA) [ Time Frame: 12 weeks ]
    A 32-item self-reported measure delineating between beneficial versus maladaptive interoceptive attention.
  • Oswestry Disability Index (ODI) [ Time Frame: 12 weeks ]
    A 10-item self-reported measure quantifying a subjective percentage score of level of function (disability) in activities of daily living in those with chronic low back pain.
  • SF-12 Health Survey [ Time Frame: 12 weeks ]
    A 12-item self-report questionnaire measuring functional health and well-being from the patient's point of view.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain
Official Title  ICMJE D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain
Brief Summary The purpose of this study is to evaluate the efficacy and safety of D-cycloserine versus placebo in relieving the signs and symptoms of patients with chronic lower back pain.
Detailed Description This is a 26-week, double-blind, randomized, placebo-controlled two-arm parallel-group trial of d-cycloserine, a pharmacological treatment selected based on positive results from previous preclinical and clinical studies, for the treatment of chronic, refractory low back pain (CBP). After a 2-week screening period, individuals will be randomized to receive either 12 weeks of d-cycloserine or placebo and then followed for an additional 12 weeks to evaluate persistence of benefit at study endpoint, 24 weeks after randomization. During the 12-week treatment period, participants will undergo evaluation at baseline and at clinic visits on weeks 2, 6 and 12 after randomization to assess pain, proper treatment use and side effects. During the subsequent 12-week follow-up period, pain and safety will continue to be assessed monthly by phone calls. All patients will also be assessed daily using an electronic diary (eDiary) to record pain and mood. T1-MRI, resting state fMRI DTI-MRI, and ASL will be performed at baseline and at the end of 12 weeks for individuals completing MRI.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Triple
Primary Purpose: Treatment
Condition  ICMJE
  • Low Back Pain
  • Pain
Intervention  ICMJE
  • Drug: D-cycloserine
    200 mg BID (twice daily)
  • Drug: Placebo
    BID (twice daily)
Study Arms  ICMJE
  • Experimental: D-cycloserine
    D-cycloserine 200 mg BID (twice daily)
    Intervention: Drug: D-cycloserine
  • Placebo Comparator: Placebo
    Placebo BID (twice daily)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2018)
244
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have a history of low back pain for a minimum of 6 months with or without signs and symptoms of radiculopathy
  • Male or female, age 18 years or older, (no racial/ethnic restrictions)
  • Must have an average pain score of ≥ 4 (on a 0-10 NRS) over a 5-7 day period (minimum of daily eDiary entries for at least 5 of 7 days) immediately preceding the baseline visit (visit 2)
  • Must be willing to read and able to understand instructions as well as PROs
  • Must be in generally stable health
  • 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
  • Must be willing to discontinue all pain medications for chronic back pain (listed below) except the study medication and rescue medication provided and not use the following prohibited pain medications throughout the duration of the treatment period

    • analgesics including OTC medications
    • NSAIDS including OTC medications
    • Coxibs
    • Opioids
    • Muscle relaxants
    • Gabapentinoids including pregabalin and gabapentin
  • Must be willing to comply with recording pain, mood, and study treatment adherence twice daily using study eDiary
  • 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 during the course of the study.

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, or history of surgery or tumor in the back within the past 6 months
  • Involvement in litigation regarding their back pain or has a disability claim or is receiving workman's compensation or is seeking either as a result of their low back pain
  • Epidural steroid injection within the past 3 months
  • History of seizures
  • Major psychiatric disorder during the past 6 months
  • Beck Depression Inventory II score of >28
  • Significant renal disease or severe renal insufficiency
  • Substance abuse/dependence including alcohol within the past 6 months
  • Significantly abnormal laboratory values
  • Pregnant or lactating at the time of randomization
  • Known sensitivity to D-cycloserine
  • Currently taking any of the following medications: ethionamide, dilantin, isoniazid (INH)
  • In the judgment of the investigator, unable or unwilling to follow the protocol and instructions
  • Any change in medication or physical therapy regime for back pain in the last 30 days.
  • Chronic progressive neurologic conditions, including Parkinson's disease, Alzheimer's disease, and other conditions associated with dementia
  • Significant other medical disease such as congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy
  • Presence of undiagnosed skin lesions or history of melanoma
  • Current use of recreational drugs
  • Current use of medical marijuana
  • High dose opioid prophylaxis, defined as > 50mg morphine equivalent/day
  • Intra-axial implants (e.g. spinal cord stimulators or pumps)
  • Pregnancy or inability to use an effective method of birth control in sexually active men and women while taking the study drug and for one week thereafter. Barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (IUD's), hormonal contraceptives, oral contraceptive pills, surgical sterilization, and complete abstinence are examples of effective methods of contraception.
  • Following laboratory abnormalities: liver function tests (SGOT/SGPT) greater than 2.5 times the upper limit of normal; unexplained anemia; evidence of renal insufficiency (creatinine > upper limit of normal) or any other abnormality that the principal investigator feels puts the participant at risk during the study.
  • Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk
  • Lactose allergy
  • Ongoing participation in another clinical research study involving an investigational product or having received another investigational product within the last 90 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Byron Yip, MSc 312-503-4856 b-yip@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03535688
Other Study ID Numbers  ICMJE STU00205398
A-20364 ( Other Grant/Funding Number: Department of Defense )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas J. Schnitzer, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Thomas J. Schnitzer, MD, PhD Northwestern University
PRS Account Northwestern University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP