Development of a Novel Soluble Epoxide Hydrolase Inhibitor as a Strategy for Treating Neuropathic Pain in Patients with Spinal Cord Injury
Abstract
Persons in the military are at increased risk for serious injuries such as a spinal cord injury (SCI). In addition, accidents and diseases can also lead to an SCI. Unfortunately, chronic pain, in some cases severe chronic pain, is present in a substantial number of persons with SCI. Treatment options are limited for the chronic neuropathic pain related to SCI, and many patients continue to suffer. In addition, some patients become addicted to opioid pain killers and have serious problems from this addiction, including both physical and socioeconomic consequences. Safe, effective, non-addictive medications to treat pain in persons with an SCI are urgently needed. The human body has natural cell signaling mediators called epoxy-fatty acids, which play a key role in improving inflammation and pain. However, these epoxy-fatty acids are broken down in the body by an enzyme called soluble epoxide hydrolase. Recent work has demonstrated that inhibition of enzymatic breakdown can maintain stable levels of these epoxy-fatty acids so that they can do their work in the body and block pain. This proposal will utilize a newly developed soluble epoxide inhibitor available to take by mouth (oral), which has safely and effectively been used in animal studies and has completed safety studies in normal human volunteers (phase 1 studies) with no problems identified. In this study, we will include 36 men and women with an SCI of at least 12 months duration who suffer from neuropathic pain below the level of their injury. The primary purpose of this study is to determine the safety of this novel new soluble epoxide inhibitor for treatment of chronic pain. The second purpose is to see if we can use blood tests to identify those patients who might best benefit from treatment with this drug for future trials. This study has the potential to provide clinical benefits for patients living with chronic pain who have an SCI. If the study results are positive and there is a demonstration of safety, it will provide the foundation for future large randomized clinical trials, including sufficient numbers of patients to see if this drug can substantially help patients with an SCI living with chronic neuropathic pain.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110288
Entities
People
- Laura D Carbone
Organizations
- Augusta University
- United States Army