Study of EC5026, a New Oral Drug for Neuropathic Pain in Adults with Spinal Cord Injury

What this Trial Is About

Researchers are evaluating the safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain caused by traumatic or non-traumatic spinal cord injury SCI. This Phase 1 clinical trial aims to determine if EC5026 is safe and well tolerated in SCI patients experiencing neuropathic pain and to study its effects on pain. The study compares EC5026 to a placebo to better understand its impact in this patient population. Participants will receive EC5026 or a matching placebo orally once daily for 14 consecutive days, divided into two treatment periods. In the first period, participants take a 6 mg loading dose on Day 1 followed by 2 mg maintenance doses on Days 2 to 7. In the second period, the dose increases to an 8 mg loading dose on Day 8 and 4 mg maintenance doses on Days 9 to 14. All participants will receive both dose regimens consecutively. The study is randomized and quadruple-masked to ensure unbiased results. During the trial, participants will undergo physical examinations, vital sign assessments, ECGs, and blood draws. They will also complete evaluations related to pain, sleep quality, functional status, and perception of change. Researchers will monitor adverse events and serious adverse events over 30 days to assess safety and tolerability. The total participation includes daily dosing for 14 days with ongoing assessments throughout the study period.

Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury