Actively Recruiting
Development of a Novel Soluble Epoxide Hydrolase Inhibitor as a Strategy for Treating Neuropathic Pain in Patients With SCI
Led by EicOsis Human Health Inc. · Updated on 2026-02-17
36
Participants Needed
1
Research Sites
17 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
Researchers are evaluating the safety and tolerability of multiple oral doses of EC5026 in adult patients with neuropathic pain caused by traumatic or non-traumatic (degenerative) spinal cord injury. This Phase 1 trial aims to determine whether EC5026 is safe and well tolerated in these patients and also to study its effects on pain. EC5026 has shown promise in preclinical models, and previous Phase 1 studies in healthy volunteers assessed its safety and pharmacokinetics. The study involves two consecutive treatment periods. Each period lasts 7 days, during which participants will take EC5026 orally once daily. In Treatment Period 1, a 6 mg loading dose is given on Day 1 followed by 2 mg maintenance doses from Days 2 to 7. Treatment Period 2 involves an 8 mg loading dose on Day 8 and 4 mg maintenance doses from Days 9 to 14. Participants will also receive a matching placebo in a randomized, quadruple-masked design for comparison. Participants will undergo physical exams, vital sign checks, ECGs, and blood tests throughout the study. They will complete assessments regarding their pain, sleep quality, functional status, and perception of change. The main outcome is the incidence of adverse events over 30 days to evaluate safety and tolerability. The total duration of treatment is 14 days, with ongoing monitoring to assess both safety and pain-related outcomes.
CONDITIONS
Brief 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 or female participants aged 18 years or older
- Willingness to provide written informed consent
- Ability to provide own transportation to the study site every day during the study
- Diagnosis of either traumatic or non-traumatic spinal cord injury with neuropathic pain lasting at least 12 months
- Neuropathic pain meeting International Spinal Cord Injury Pain classification criteria
- Average daily pain intensity between 4 and 9 on an 11-point numerical rating scale with stable variability
- Failure of at least two classes of medications for neuropathic pain
- Overall stable condition based on medical history, physical exam, lab tests, and ECG
- Normal or not clinically significant lab test results including coagulation panel and creatinine clearance ≥60 cm3/min
- Negative screening for HIV, Hepatitis B and C within 30 days prior to randomization
- Normal hypothalamic-pituitary-adrenal and gonadal axis function
- Negative urinary drug screen for illicit drugs (except marijuana/THC) and serum ethanol level <80 mg/dL
- Agreement to use contraception for males and females as described during and after the study period
- Female participants must be non-pregnant, non-lactating, and meet specific contraceptive or postmenopausal criteria
- Ability to speak, read, and understand English sufficiently to complete study assessments
You will not qualify if you...
- Ventilator-dependent individuals (except nocturnal use of CPAP or BiPAP)
- Pain not present daily or lacking classic neuropathic features
- Other chronic neuropathic pain conditions such as diabetic neuropathy, HIV-associated neuropathy, or chemotherapy-related neuropathy
- Other pain syndromes that could interfere with neuropathic pain assessment
- Presence of only numbness without spontaneous pain
- Use of opioid medications exceeding 60 morphine milligram equivalents per day or unstable dosing
- Active Hepatitis A, B, or C infections
- Clinically unstable or significant cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, endocrine, or infectious diseases
- Significant abnormalities in vital signs, lab tests, or ECG
- History of hypothalamic-pituitary-adrenal or gonadal disorders
- Recent use of corticosteroids, fludrocortisone, exogenous testosterone, or renin-angiotensin system drugs
- Recent chemotherapy or cancer history within 5 years (except certain skin cancers)
- Recent infections requiring treatment within 1 month prior to study
- Use of moderate to strong CYP3A4 inducers or inhibitors within 14 days prior to study
- Difficulty swallowing oral medication
- Serious psychosocial or psychiatric disorders interfering with study compliance
- Positive drug or alcohol tests above specified limits
- Use of investigational drugs within 1 month prior to enrollment
- Active gastrointestinal or coagulant disorders within 1 month prior to enrollment
- Family history of significant cardiac disease
- Recent or planned COVID-19 infection or vaccination within 30 days of randomization
- Spinal cord injury at T6 or higher with neurogenic bladder or autonomic dysreflexia history or symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive oral doses of EC5026 or matching placebo once daily for 7 consecutive days during two consecutive treatment periods with different dose regimens.
Daily visits for 14 consecutive days
Duration - 16 days
Participants are monitored for safety and adverse events after completing treatment.
Visits as scheduled over 30 days post-treatment
Trial Site Locations
Total: 1 location
1
AU Medical Center
Augusta, Georgia, United States, 30912
Actively Recruiting
Research Team
W
William K Schmidt, PhD
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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