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

NCT04688671 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ETX-018810-202
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Diabetic Peripheral Neuropathic Pain; Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 4 in the Weekly Average of the Daily Pain Score as Derived From the Subject's Responses on the Pain Intensity Numerical Rating Scale (PI-NRS)

  Change from baseline in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS) a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).

  baseline to Week 4

Secondary Outcomes (9)

• Number of Subjects With a ≥50% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score

  Baseline to Weeks 1, 2, 3 and 4

• Number of Subjects With a ≥30% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score

  Baseline to Weeks 1, 2, 3 and 4

• Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3

  Baseline to Weeks 1, 2 and 3

• Number of Subjects With a CGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4

  Week 4

• Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4.

  Week 4

Study Arms (2)

ETX-018810

EXPERIMENTAL

1000 mg BID for 4 weeks

Drug: ETX-018810

Placebo

PLACEBO COMPARATOR

matching placebo BID for 4 weeks

Drug: Placebo

Interventions

ETX-018810 DRUG

Study Drug

ETX-018810

Placebo DRUG

Matching Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• The subject is unable to refrain from using nonsteroidal anti-inflammatory drugs (NSAIDs); antiepileptic drugs, steroids, cannabinoids, or major opioids, muscle relaxants, tramadol, or tapentadol throughout the study.
• The subject has used prohibited nonpharmacologic therapies, including acupuncture, transcutaneous electrical nerve stimulation, etc, within 30 days before baseline/Day 1 or anticipates use of such therapies during the study.

Sponsors & Collaborators

• Eliem Therapeutics (UK) Ltd.: lead

Study Sites (22)

Delta Clinical Research

Mobile, Alabama, 36609, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Neuro-Pain Medical Cneter

Fresno, California, 93710, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Diabetes Research Center

Tustin, California, 92780, United States

Location

Chase Medical Research LLC

Hamden, Connecticut, 06517, United States

Location

Charter Research

Lady Lake, Florida, 32159, United States

Location

Cordova Research Institute

Miami, Florida, 33155, United States

Location

Coral Research Clinic Corp

Miami, Florida, 33186, United States

Location

Better Health Clinical Reseach

Newnan, Georgia, 30265, United States

Location

Medisphere Medical Research Center

Evansville, Indiana, 47714, United States

Location

StudyMetrix Research LLC

City of Saint Peters, Missouri, 65810, United States

Location

Alliance for Multispeciality Research LLC

Las Vegas, Nevada, 89119, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

IMA Clinical Research

New York, New York, 10036, United States

Location

Upstate Clinical Research Associates

Williamsville, New York, 14221, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Alpine Research Organization

Clinton, Utah, 84015, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84107, United States

Location

Wasatch Clinical Research LLC

Salt Lake City, Utah, 84107, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Results Point of Contact

• Title: Clinical Operations
• Organization: Eliem Therapeutics

studyinfo@eliemtx.com

+1-888-506-2573

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-Controlled, Parallel-Group

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: December 30, 2020
• Study Start: November 9, 2020
• Primary Completion: February 9, 2022
• Study Completion: February 18, 2022
• Last Updated: November 7, 2023
• Results First Posted: May 16, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)