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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03535688
Study type Interventional
Source Northwestern University
Contact Byron Yip, MSc
Phone 312-503-4856
Email b-yip@northwestern.edu
Status Recruiting
Phase Phase 3
Start date March 30, 2018
Completion date March 2022

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