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

  • STATUS
    Recruiting
  • End date
    Dec 23, 2023
  • participants needed
    244
  • sponsor
    Northwestern University
Updated on 23 March 2022
analgesics
opioid
chronic pain
back pain
gabapentin
NSAID
pregabalin
muscle relaxants
low back pain
radiculopathy

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.

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.

Details
Condition Low Back Pain, Pain
Treatment Placebo, D-cycloserine
Clinical Study IdentifierNCT03535688
SponsorNorthwestern University
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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 new or untreated psychiatric disorder during the past 6 months and/or ongoing treatment with buproprion or fluphenazine
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
Other medical disease such as clinically significant 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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