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

NCT06438471 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: EC5026-1-04CDMRP-SC200001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Cord Injuries; Neuropathic Pain; Degenerative Disc Disease; Spinal Stenosis; Spondylosis

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability]

  All AEs reported or observed during the study will be recorded on the electronic case report forms (eCRF). Information to be collected includes drug treatment, type of event, time of onset, dosage, investigator-specified assessment of severity and relationship to study drug, time of resolution of the event, seriousness, any required treatment or evaluations, and outcome. Any AEs resulting from concurrent illnesses, reactions to concurrent illnesses, reactions to concurrent medications, or progression of disease states must also be reported. All AEs will be followed until they are resolved, stable, or judged by the investigator to be not clinically significant. The Medical Dictionary for Regulatory Activities will be used to code all AEs.

  30 days

Other Outcomes (24)

• Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on plasma levels of EC5026

  30 days

• Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on oxylipin biomarkers.

  30 days

• Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on target engagement biomarkers.

  30 days

Study Arms (2)

EC5026

EXPERIMENTAL

Multiple oral doses of EC5026

Drug: EC5026 oral tablet

Placebo

PLACEBO COMPARATOR

Matching oral placebo

Drug: Placebo oral tablet

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

EC5026

Placebo oral tablet DRUG

Participants will be administered a matching oral placebo for 14 consecutive days.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each subject must meet all of the following criteria to be enrolled in this study:
• Male and female subjects must be 18 and older.
• Subjects must be willing to provide written informed consent to participate in the study.
• Subjects must be able to provide own transportation to study site every day for the duration of the study.

You may not qualify if:

• Subjects must have completed a minimum of 6 of the 7 daily assessments for average and worst daily pain prior to final screening, using an 11-point numerical rating scale (NRS) for average daily pain intensity, and the arithmetic average daily SCI neuropathic pain score must be ≥4 and ≤9, with a standard deviation less than or equal to 1.2. Daily pain assessment screenings will be done over the phone with the study coordinator after informed consent is obtained.
• Subjects must have failed at least 2 classes of medications for their neuropathic pain due to SCI (classes may include antidepressants, antiepileptics, opioids, anti-inflammatories, topical treatments, etc.).
• Subjects must be in overall stable condition, as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12 lead ECG measurements
• Subjects must have a negative screening for HIV, Hepatitis C, and Hepatitis B within 30 days of randomization.
• Subjects must have a normal hypothalamic-pituitary-adrenal and hypothalamic-pituitary-gonadal axes screening study.
• Subjects must have a negative urinary drug screen (UDS) for illicit drugs (marihuana/THC are allowed) and serum ethanol level \<80 mg/dL.
• Male subjects who are not surgically sterile (vasectomized) and their female sexual partners must agree to use contraception during the study period and for 2 months afterward.
• Male subjects must not donate sperm during the study and for 12 months after receiving the last dose of study drug.
• Female subjects must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile (bilateral tubal ligation ('clipping or tying tubes' or hysterectomy) for at least 3 months, or they must agree to use two forms of highly effective contraception method (less than 1 pregnancy per 100 people using the method for one year), from 28 days and/or their last confirmed menstrual period prior to study enrollment (whichever is longer) until 2 months after clinic discharge. Postmenopausal status will be defined as follow: minimum 1 year; amenorrhea duration of 12 consecutive months and a serum FSH value \>40 IU/L; postmenopausal status must be confirmed by an FSH test at Screening). Highly effective contraception methods include: Intra-uterine device (IUD) containing either copper or levonorgestrel (e.g., Mirena®), and/or barrier methods of contraception, including condoms (external or internal) and diaphragm ('cap'). Hormonal methods of contraception (with the exception of hormonal IUD) are not permitted within this study. Female participants will refrain from using hormonal contraceptives for at least 28 days prior to study entry until the end of the study period. Participants/Participant's partner(s) must also use a barrier form of contraception, from the first dose of study drug through until 2 months after the last dose. For all females of childbearing potential, the pregnancy test result must be negative at Screening and Pre-Study Baseline (Day -1).
• Subjects must be able to speak, read, and understand English sufficiently to allow comprehension and completion of all study assessments.
• Subjects meeting any of the following criteria will be excluded from the study:
• Ventilator-dependent subjects, with the exception of nocturnal use of CPAP or BiPAP.
• Subjects with pain that is not present every day (chronic) or where the pain description does not have a classic neuropathic phenotype.
• Subjects with other chronic neuropathic pain conditions, including painful diabetic neuropathy, HIV-associated neuropathic pain, chemotherapy or ethanol-associated neuropathy.
• Subjects with other pain syndromes that may confound assessment or self-evaluation of the SCI neuropathic pain.

Sponsors & Collaborators

• EicOsis Human Health Inc.: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

AU Medical Center

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylosis

Interventions

EC5026

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• William K Schmidt, PhD

  EicOsis Human Health Inc.

  STUDY DIRECTOR

Central Study Contacts

William K Schmidt, PhD

CONTACT

650-438-3018; wkschmidt@eicosis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 3, 2024
• Study Start: February 28, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)