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Enzyme Inhibitor

EC5026 for Neuropathic Pain

Phase 1

Recruiting

Research Sponsored by EicOsis Human Health Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have a complete or incomplete C2-T12 SCI of at least 12 months duration, with below-level neuropathic pain identified by the International Spinal Cord Injury Pain (ISCIP) classification criteria

Subjects must have a negative urinary drug screen (UDS) for illicit drugs (marihuana/THC are allowed) and serum ethanol level <80 mg/dL

Must not have

Subjects with confirmed COVID-19, or suspected COVID-19 (e.g., developed symptoms of a respiratory infection such as cough, sore throat, shortness of breath, or fever, but did not get tested for COVID-19) within 30 days of randomization

Subjects with other chronic neuropathic pain conditions, including painful diabetic neuropathy, HIV-associated neuropathic pain, chemotherapy or ethanol-associated neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Summary

"This trial aims to test the safety and tolerability of EC5026 in male and female patients with neuropathic pain from spinal cord injury. The main focus is to determine if EC5026 is

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to EC5026 compared to those taking the placebo. Common side effects may include gastrointestinal issues or changes in vital signs as typically observed in medication trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a spinal cord injury between C2-T12 for over a year and suffer from below-level neuropathic pain.

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

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I am a man who is not vasectomized and will use contraception during and 2 months after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or am suspected to have had COVID-19 in the last 30 days.

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I have chronic nerve pain from conditions like diabetes, HIV, chemotherapy, or alcohol use.

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I have other pain conditions that could affect my ability to assess my spinal cord injury pain.

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I have active Hepatitis A, B, or C.

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I do not have any major health issues like heart, kidney, liver, lung, blood, hormone disorders, or infections including HIV.

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I have not used, and do not plan to use, strong medication that affects liver enzymes recently or during the study.

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I have not used, nor plan to use, any products like grapefruit juice that affect how drugs work.

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I have trouble swallowing pills.

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I haven't used chemotherapy or had cancer, except for non-spreading skin cancer, in the last 5 years.

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I have been vaccinated for COVID-19 recently or plan to during the study.

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I have a history of adrenal or pituitary gland disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Other outcome measures

Change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to Day 11.

Change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to Day 14.

Change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to Day 21.

+18 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EC5026Experimental Treatment1 Intervention

Multiple oral doses of EC5026

Group II: PlaceboPlacebo Group1 Intervention

Matching oral placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EC5026 oral tablet

2021

Completed Phase 1

~20

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

EicOsis Human Health Inc.Lead Sponsor

4 Previous Clinical Trials

104 Total Patients Enrolled

William K Schmidt, PhDStudy DirectorEicOsis Human Health Inc.

6 Previous Clinical Trials

447 Total Patients Enrolled

~24 spots leftby Jun 2025

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