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

TerminatedPhase 2NCT03535688
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain
Sponsor
Northwestern University
Collaborators
United States Department of Defense
Start date
2018-03-30
Primary completion
2024-02-07
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 patient reported outcomes (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 over the counter (OTC) medications * NSAIDS including OTC medications * Coxibs * Opioids * Muscle relaxants * Gabapentins 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…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03535688