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

Part of paid clinical trials in Augusta, Georgia.

Sponsor
EicOsis Human Health Inc.
Study ID
NCT06438471
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EC5026 oral tablet — DRUG
    There will be two ascending dose regimens of EC5026, which will be administered over two consecutive Treatment Periods. During each Treatment Period, EC5026 will be administered orally once daily for 7 consecutive days, with a loading dose on Day 1 and a maintenance dose on Days 2-7 of each treatment period. All study subjects will be enrolled in both Treatment Periods and will receive both dose regimens consecutively, for a total duration of 14 days. Oral doses of EC5026 tested in each Treatment Period: Treatment Period 1: 6 mg loading dose on Day 1 / 2 mg Maintenance dose on Days 2-7 Treatment Period 2: 8 mg loading dose on Day 8 / 4 mg Maintenance dose on Days 9-14
  • Placebo oral tablet — DRUG
    Participants will be administered a matching oral placebo for 14 consecutive days.

Study Details

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

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EC5026
    Multiple oral doses of EC5026
  • Placebo Comparator: Placebo
    Matching oral placebo

Primary Outcome Measure

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability] [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AU Medical CenterAugustaGeorgia30912
Martha Farrough
[email protected]

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By research site
AU Medical Center· Augusta, GA

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