Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury
This study tests a new medication called EC5026 to see if it is safe and well-tolerated in people with nerve pain caused by spinal cord injury. Researchers will give participants multiple doses of the drug by mouth and carefully monitor them for any side effects.
Key Objective: EC5026 may help reduce neuropathic pain in patients with spinal cord injuries by targeting a specific enzyme involved in pain signaling.
Who to Consider: People with traumatic or non-traumatic spinal cord injury who experience chronic neuropathic pain may want to consider enrolling in this trial.
Trial Parameters
Brief Summary
The goal of this clinical trial is to evaluate safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain due to traumatic or non-traumatic (degenerative) spinal cord injury. The main question it aims to answer is whether EC5026 is safe and well tolerated in SCI patients with neuropathic pain. In addition, this trial will also study the effects of EC5026 on pain. Researchers will compare EC5026 to placebo. Participants will be asked to: * Take EC5026 or placebo in a masked fashion, once daily, for 14 consecutive days. * Undergo physical exams, vital signs assessments, ECGs, and blood draws * Complete assessments of pain, sleep, functional status, and perception of change
Eligibility Criteria
Inclusion Criteria: Each subject must meet all of the following criteria to be enrolled in this study: 1. Male and female subjects must be 18 and older. 2. Subjects must be willing to provide written informed consent to participate in the study. 3. Subjects must be able to provide own transportation to study site every day for the duration of the study. 4. Subjects with either a traumatic or a non-traumatic SCI may be eligible to enroll in this study. For subjects with complete or incomplete traumatic spinal cord injuries (tSCI), or complete non-traumatic spinal cord injury: Subjects must have a complete or incomplete T6 or below tSCI, or complete non-traumatic SCI of at least 12 months duration, with below-level neuropathic pain identified by the International Spinal Cord Injury Pain (ISCIP) classification criteria. Importantly, subjects must not be ventilator-dependent as detailed in Exclusion Criteria 1. For subjects with degenerative partial spinal cord injuries (pSCI): Subjects mu