EC5026 for Neuropathic Pain

Overseen By William K Schmidt, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: EicOsis Human Health Inc.

Must not be taking: Opioids, Corticosteroids, RAS-acting drugs, others

Disqualifiers: Ventilator-dependence, Chronic pain, Cardiovascular, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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 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

Research Team

William K Schmidt, PhD

Principal Investigator

EicOsis Human Health Inc.

Eligibility Criteria

This trial is for U.S. Veterans aged 18+ with spinal cord injury (SCI) and neuropathic pain lasting over a year. Participants must be in stable health, have no major psychiatric disorders, not use opioids regularly, and agree to contraception if applicable. They should not have significant medical conditions or recent infections, cancer history within 5 years (except nonmetastatic skin cancer), or plans to receive a COVID-19 vaccine during the study.

Inclusion Criteria

I am a US Veteran aged 18 or older.

I have passed a drug test, except for marijuana, and my alcohol level is low.

Subjects must be willing to provide written informed consent to participate in the study

Exclusion Criteria

My pain is not daily or typically nerve-related.

Subjects with clinically significant abnormalities on screening vital signs, laboratory tests, and/or ECG. Subjects with poor venous access will also be excluded

I only experience numbness without any spontaneous pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take EC5026 or placebo in a masked fashion, once daily, for 14 consecutive days. They undergo physical exams, vital signs assessments, ECGs, and blood draws, and complete assessments of pain, sleep, functional status, and perception of change.

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including adverse events and changes in pain scores.

4 weeks

Treatment Details

Interventions

• EC5026

Trial Overview The trial tests EC5026 against a placebo to see if it's safe and can help manage neuropathic pain from SCI. Patients will take the oral tablet daily for two weeks while undergoing physical exams, ECGs, blood tests, and assessments of their pain levels and overall well-being.

Participant Groups

Group I: EC5026 Experimental Treatment 1 Intervention

Multiple oral doses of EC5026

Group II: Placebo Placebo Group 1 Intervention

Matching oral placebo

Who Is Running the Clinical Trial?

EicOsis Human Health Inc.

Lead Sponsor

Trials

5

Recruited

140+