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

Pain Clinical Trial

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

Status Terminated

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. Magnetic resonance imaging (MRI), anatomical MRI, resting state functional MRI (fMRI), diffusion-tensor imaging (DTI) MRI, and arterial spin labeling (ASL) will be performed at baseline and at the end of 12 weeks for individuals completing MRI. ;

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pain

• NCT number: NCT03535688
• Study type: Interventional
• Source: Northwestern University
• Status: Terminated
• Phase: Phase 2
• Start date: March 30, 2018
• Completion date: June 6, 2023