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

NCT03535688 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: STU00205398A-20364
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Pain

Keywords

Chronic Pain; Low Back Pain; D-cycloserine

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Rating Scale (NRS) Pain Score 0-10; Higher Worse

  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.

  12 weeks

Secondary Outcomes (14)

• Effect of Gender on Magnitude of Pain Response.

  12 weeks

• Brain Biomarkers (MRI)

  12 weeks

• Patient Global Assessment

  12 weeks

• Patient Global Impression of Change

  12 weeks

• McGill Pain Questionnaire (MPQ)

  12 weeks

Study Arms (2)

D-cycloserine

EXPERIMENTAL

D-cycloserine 200 mg twice daily

Drug: D-cycloserine

Placebo

PLACEBO COMPARATOR

Placebo twice daily

Drug: Placebo

Interventions

Placebo DRUG

twice daily

Placebo

D-cycloserine DRUG

200 mg twice daily

D-cycloserine

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 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.

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, 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.

Sponsors & Collaborators

• Northwestern University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Pinto CB, Bielefeld J, Barroso J, Yip B, Huang L, Schnitzer T, Apkarian AV. Chronic pain domains and their relationship to personality, abilities, and brain networks. Pain. 2023 Jan 1;164(1):59-71. doi: 10.1097/j.pain.0000000000002657. Epub 2022 Apr 20. No abstract available.

  PMID: 35612403 DERIVED

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

Results Point of Contact

• Title: Dr. Santiago Espinosa Salas
• Organization: Northwestern University Feinberg School of Medicine

santiagoespinosa@northwestern.edu

312 503 3283

Study Officials

• Thomas J. Schnitzer, MD, PhD

  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
• Masking Details: Triple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: May 24, 2018
• Study Start: March 30, 2018
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: May 4, 2026
• Results First Posted: May 4, 2026

Record last verified: 2026-04

Locations

US (1)