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Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain | Clinical Trials | Clareo Health

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Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects With Diabetic Peripheral Neuropathic Pain

NCT04688671•Eliem Therapeutics (UK) Ltd.

View on ClinicalTrials.gov

Summary

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Diabetic Peripheral Neuropathic Pain.

Detailed Description

ETX-018810 is a new chemical entity that is under development as a non-opioid treatment for chronic pain syndromes. ETX-018810 is a prodrug of palmitoylethanolamide (PEA), an endogenous bioactive lipid that has shown efficacy in a broad range of nonclinical inflammatory and neuropathic pain models and in clinical trials in chronic pain indications, including diabetic peripheral neuropathic pain (DPNP).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject is ≥18 and ≤75 years of age at the time of signing ICF.
•The subject has a diagnosis of type 1 or 2 diabetes mellitus.
•The subject has diabetic neuropathy of a symmetrical nature in the lower extremities for ≥6 months to ≤10 years
•The subject reports at least moderate pain intensity
•The subject's onset of neuropathic pain is at least 3 months before the screening visit.
•The subject has used a stable regimen of antidiabetic agents for at least 1 month before the baseline visit or has achieved adequate glycemic control through diet and exercise.
•The subject has clinical laboratory values within normal limits or abnormal values that the investigator deems not clinically significant.
•Sexually active male subjects with female partners of childbearing potential and sexually active female subjects of childbearing potential must agree to practice effective contraception or to remain abstinent during the study and for 4 weeks after the last dose of investigational product
•The subject is capable of giving signed informed consent and agrees to provide authorization for use and release of health records.

Exclusion Criteria

•The subject has pain that cannot be clearly differentiated from or that could interfere with the assessment of DPNP.
•The subject has neurologic and/or circulatory disorders that are unrelated to diabetic neuropathy
•The subject has a history of hypoglycemia that disturbed consciousness or ketoacidosis that required hospitalization within the 3 months before screening.
•The subject has clinically significant and/or unstable renal, hepatic, hematologic, immunologic, inflammatory/rheumatologic, respiratory, or cardiovascular disease that would compromise participation in the study in the judgment of the investigator.
•The subject has any neurological disease that could interfere with participation in the study (eg, Huntington's disease, Parkinson's disease, Alzheimer's disease, multiple sclerosis, seizures, epilepsy, stroke).
•The subject has an amputation of a lower extremity. Toe amputation is allowed.
•The subject has clinically significant abnormal electrocardiogram (ECG) findings at screening or baseline.
•The subject is likely to require major surgery during the study.
•The subject is pregnant or lactating.
•The subject is unwilling or unable to discontinue current medications for neuropathic pain, including topical agents.
+2 more criteria

Locations (22)

Delta Clinical Research

Mobile, Alabama, United States

Arizona Research Center

Phoenix, Arizona, United States

Neuro-Pain Medical Cneter

Fresno, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Diabetes Research Center

Tustin, California, United States

Chase Medical Research LLC

Hamden, Connecticut, United States

Charter Research

Lady Lake, Florida, United States

Cordova Research Institute

Miami, Florida, United States

Coral Research Clinic Corp

Miami, Florida, United States

Better Health Clinical Reseach

Newnan, Georgia, United States

Key Dates

Start Date

November 9, 2020

Primary Completion Date

February 9, 2022

Completion Date

February 18, 2022

Last Updated

November 7, 2023

Enrollment

167

ACTUAL participants

Conditions

Diabetic Peripheral Neuropathic PainDiabetic Peripheral Neuropathy

Interventions

ETX-018810

DRUG

Placebo

DRUG

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RECRUITINGNA

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RECRUITING

Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain

Inclusion Criteria

Exclusion Criteria

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain

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Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire

Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy

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