Actively Recruiting
Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury
Led by EicOsis Human Health Inc. · Updated on 2026-02-17
36
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
E
EicOsis Human Health Inc.
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects must be 18 years old or older
- Willing to provide written informed consent
- Able to provide own transportation to study site every day during the study
- Have either traumatic or non-traumatic spinal cord injury with neuropathic pain lasting at least 12 months
- For traumatic SCI: complete or incomplete injury at T6 or below; for non-traumatic SCI: incomplete injury due to degenerative disorders
- Neuropathic pain must meet International Spinal Cord Injury Pain classification criteria
- Completed at least 6 of 7 daily pain assessments with average daily pain score between 4 and 9
- Have failed at least 2 classes of medications for neuropathic pain
- In stable overall condition based on medical history, physical exam, lab tests, and ECG
- Normal or clinically insignificant lab test results including coagulation, blood counts, metabolic panel, and creatinine clearance (≥60 cm3/min)
- Negative screening for HIV, Hepatitis B and C within 30 days before randomization
- Normal hypothalamic-pituitary-adrenal and hypothalamic-pituitary-gonadal axis screening
- Negative urinary drug screen for illicit drugs (except marijuana/THC) and serum ethanol level below 80 mg/dL
- Male subjects not surgically sterile and their female partners must agree to use contraception during and 2 months after study
- Male subjects must not donate sperm during study and for 12 months after last dose
- Female subjects must be non-pregnant, non-lactating, postmenopausal for at least 1 year, surgically sterile, or agree to use two highly effective contraception methods from 28 days before enrollment until 2 months after study
- Able to speak, read, and understand English to complete study assessments
You will not qualify if you...
- Ventilator-dependent subjects (except nocturnal CPAP or BiPAP use)
- Pain not present daily or without classic neuropathic phenotype
- Other chronic neuropathic pain conditions like diabetic neuropathy, HIV neuropathy, chemotherapy or ethanol-associated neuropathy
- Other pain syndromes that could confound neuropathic pain assessment
- Only numbness without spontaneous pain
- Use of opioid medications over 60 morphine milligram equivalents per day or unstable dose
- Active Hepatitis A, B, or C infection
- Clinically unstable or significant cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, endocrine, or infectious diseases
- Significant abnormalities on screening vital signs, labs, or ECG
- History of hypothalamic-pituitary-adrenal or gonadal axis disorders
- Use of corticosteroids, fludrocortisone, exogenous testosterone, RAS-acting drugs, or mineralocorticoid receptor antagonists recently or planned during study
- History of cancer (except excised nonmetastatic skin cancer) within 5 years
- Recent infections requiring treatment within 1 month
- Use of CYP3A4 moderate-strong inducers or inhibitors or dietary inhibitors within 14 days before randomization or during study
- Difficulty swallowing oral medications
- Serious psychosocial, cognitive, or major psychiatric disorders
- Positive drug or alcohol test or recent binge drinking
- Use of investigational drugs within 1 month before enrollment
- History or presence of active gastrointestinal, renal, hepatic, or coagulant disorders within 1 month
- Family history of significant cardiac disease
- Confirmed or suspected COVID-19 within 30 days before randomization
- Receipt of COVID-19 vaccine within 30 days before randomization or planned during study
- Spinal cord injury at T6 or higher with history of neurogenic bladder
- Documented autonomic dysreflexia or history of undiagnosed episodes consistent with it
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
AU Medical Center
Augusta, Georgia, United States, 30912
Actively Recruiting
Research Team
W
William K Schmidt, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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