Diabetic Peripheral Neuropathic PainPhase 2NCT04688671

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

A Phase 2 study testing ETX-018810 in people with Diabetic Peripheral Neuropathic Pain and Diabetic Peripheral Neuropathy, run by Eliem Therapeutics (UK) Ltd. at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetic Peripheral Neuropathic Pain, Diabetic Peripheral Neuropathy
What is being tested?: ETX-018810
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 167 participants
Where: 22 sitesUnited States
Study dates: 9 Nov 2020to 18 Feb 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

FutureSearch Trials of Neurology
Austin, Texas, 78731
Northwest Clinical Research Center
Bellevue, Washington, 98007
Hassman Research Institute
Berlin, New Jersey, 08009
StudyMetrix Research LLC
City of Saint Peters, Missouri, 65810
Alpine Research Organization
Clinton, Utah, 84015
Midwest Clinical Research Center
Dayton, Ohio, 45417
Medisphere Medical Research Center
Evansville, Indiana, 47714
Neuro-Pain Medical Cneter
Fresno, California, 93710
Chase Medical Research LLC
Hamden, Connecticut, 06517
Charter Research
Lady Lake, Florida, 32159
Alliance for Multispeciality Research LLC
Las Vegas, Nevada, 89119
Cordova Research Institute
Miami, Florida, 33155
Coral Research Clinic Corp
Miami, Florida, 33186
Delta Clinical Research
Mobile, Alabama, 36609
IMA Clinical Research
New York, New York, 10036
Better Health Clinical Reseach
Newnan, Georgia, 30265
Arizona Research Center
Phoenix, Arizona, 85053
Jean Brown Research
Salt Lake City, Utah, 84107
Wasatch Clinical Research LLC
Salt Lake City, Utah, 84107
Encompass Clinical Research
Spring Valley, California, 91978
Diabetes Research Center
Tustin, California, 92780
Upstate Clinical Research Associates
Williamsville, New York, 14221

Other trials in United States

About this study

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

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.

Read the 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).

Conditions: Diabetic Peripheral Neuropathic Pain, Diabetic Peripheral Neuropathy
Being tested: ETX-018810, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ETX-018810Drug
Study Drug
PlaceboDrug
Matching Placebo

Study groups in NCT04688671
Study group	Role	What they receive
ETX-018810	Experimental	1000 mg BID for 4 weeks Receives: Drug: ETX-018810
Placebo	Placebo comparator	matching placebo BID for 4 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
Change 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).
Measured: 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
Change 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).
Measured: 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
Change 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).
Measured: 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
The Clinical Global Impression - Change (CGI-C) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to the baseline state at the beginning of the intervention. The rater selects one response based on the following question, "Compared to your patient's condition at the beginning of treatment, how much has your patient changed?" Scores are as follows: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.
Measured: Week 4
Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4.
The Patient Global Impression - Change (PGI-C) is the patient-reported counterpoint to the CGI C (Guy, 1976). The qualitative assessment of meaningful change is determined by the patient in response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" Scores are as follows: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.
Measured: Week 4
Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4
The Daily Sleep Interference Scale (DSIS) is an 11-point response scale that quantifies sleep interference due to pain. It is a single-item measure that is completed once daily, upon awakening, to accurately capture variability in sleep interference due to pain on a daily basis, thus minimizing recall bias. Patients are asked to select the number that best describes how much their pain has interfered with their sleep during the last 24 hours on a scale from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep).
Measured: Baseline to Weeks 1, 2, 3 and 4
Change in the BPI - Interference Scale From Baseline to Week 4
The BPI Interference scale measures how much pain has interfered with seven daily activities scored on a scale from 0 (does not interfere) to 10 (completely interferes). It is scored as the mean of the seven interference items.
Measured: Baseline to Week 4
Change in the BPI-Pain Scale From Baseline to Week 4
The BPI pain scale is a composite of 4 items assessing pain severity (worst, least, average, and right now). Subjects rate their pain in last 24 hours on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). It is scored as the mean of the four pain items.
Measured: Baseline to Week 4
Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4
The daily amount of acetaminophen (rescue medication) that was used (mg per day).
Measured: Baseline to week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 202018 Feb 2022

First posted30 Dec 2020
Study start9 Nov 2020
Primary completion9 Feb 2022
Study completion18 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Placebo-Controlled, Parallel-Group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04688671
Sponsor's protocol ID: ETX-018810-202
Status last verified: Nov 2023
First submitted: 25 Dec 2020
Last updated: 7 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy

All Diabetic Peripheral Neuropathic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04688671
Acronym / sponsor ID: ETX-018810-202
Conditions: Diabetic Peripheral Neuropathic Pain, Diabetic Peripheral Neuropathy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 167 participants (actual)
Lead sponsor: Eliem Therapeutics (UK) Ltd.Industry (pharma, biotech, devices)
Study start: 9 Nov 2020 (actual)
Primary completion: 9 Feb 2022 (actual)
Study completion: 18 Feb 2022 (actual)
First posted: 30 Dec 2020 (actual)
Results: Posted 16 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Placebo-Controlled, Parallel-Group

Arm	Type	Receives
ETX-018810	Experimental	Drug: ETX-0188101000 mg BID for 4 weeks
Placebo	Placebo comparator	Drug: Placebomatching placebo BID for 4 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (12 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ETX-018810Study Drug	Drug	ETX-018810
PlaceboMatching Placebo	Drug	Placebo

Primary outcome

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)
Time frame: baseline to Week 4
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).

9 secondary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 4
Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4.
Time frame: Week 4
Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4
Time frame: Baseline to Weeks 1, 2, 3 and 4
Change in the BPI - Interference Scale From Baseline to Week 4
Time frame: Baseline to Week 4
Change in the BPI-Pain Scale From Baseline to Week 4
Time frame: Baseline to Week 4
Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4
Time frame: Baseline to week 4

Results and safety

Results posted to the registry on 16 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ETX-018810	83	75
Placebo	84	80

Primary outcome: 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)

Time frame: baseline to Week 4. Mean (Standard Deviation). Unit: score on a scale

Measure	ETX-018810 n = 74	Placebo n = 78
Value	-1.79 (2.099)	-1.91 (1.781)

ETX-018810 vs Placebo: Mean Difference (Final Values): 0.18 (90% CI -0.32 to 0.68), p = 0.5605, Mixed Models Analysis

Population analysed: The modified ITT population included all randomized subjects who received at least one dose of study treatment and had at least four post-baseline PI-NRS measurements; 78 and 81 subjects for the ETX-018810 and Placebo groups, respectively. All subjects in this population were included in the statistical analysis comparing the groups. However, the descriptive summary for Week 4 only included those subjects who had measurements at Baseline and Week 4 (74 and 78 subjects, respectively).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ETX-018810	1 of 83 (1.2%)	22 of 83 (26.5%)	0 of 83
Placebo	0 of 84 (0%)	11 of 84 (13.1%)	0 of 84

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Diabetic Peripheral Neuropathic Pain

Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ETX-018810 in people with Diabetic Peripheral Neuropathic Pain and Diabetic Peripheral Neuropathy, run by Eliem Therapeutics (UK) Ltd. at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: baseline to Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04688671.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.