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

Sponsor

Eliem Therapeutics (UK) Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04688671

Collaborator

(none)

167

Enrollment

Location

Arms

15.3

Actual Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Peripheral Neuropathic Pain Diabetic Peripheral Neuropathy	Drug: ETX-018810 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

167 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Placebo-Controlled, Parallel-GroupPlacebo-Controlled, Parallel-Group

Masking:

Double (Participant, Investigator)

Masking Description:

Double-Blind

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 9, 2020

Actual Primary Completion Date :

Feb 9, 2022

Actual Study Completion Date :

Feb 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ETX-018810	Drug: ETX-018810 Study Drug
Placebo Comparator: Placebo	Drug: Placebo Matching Placebo

Arm

Intervention/Treatment

Experimental: ETX-018810

Drug: ETX-018810

Study Drug

Placebo Comparator: Placebo

Drug: Placebo

Matching Placebo

Outcome Measures

Primary Outcome Measures

To evaluate the efficacy of ETX 018810 on neuropathic pain via daily pain measurements in subjects with diabetic peripheral neuropathic pain (DPNP) [baseline to Week 4]
Change from 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMR of Greater New Haven	Hamden	Connecticut	United States	06517

Sponsors and Collaborators

Eliem Therapeutics (UK) Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eliem Therapeutics (UK) Ltd.

ClinicalTrials.gov Identifier:

NCT04688671

Other Study ID Numbers:

ETX-018810-202

First Posted:

Dec 30, 2020

Last Update Posted:

Mar 25, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neuralgia

Peripheral Nervous System Diseases

Diabetic Neuropathies

Study Results

No Results Posted as of Mar 25, 2022