Clinical trial NCT04688671: Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathy
Lead sponsor: Eliem Therapeutics (UK) Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-30
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo-Controlled, Parallel-Group
Primary purpose: TREATMENT

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.

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 criteria: 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.

Primary outcomes:
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)
timeFrame: baseline to Week 4
Secondary outcomes:
measure: 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
timeFrame: Baseline to Weeks 1, 2, 3 and 4
measure: 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
timeFrame: Baseline to Weeks 1, 2, 3 and 4
measure: Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3
timeFrame: Baseline to Weeks 1, 2 and 3
measure: Number of Subjects With a CGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4
timeFrame: Week 4
measure: Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4.
timeFrame: Week 4
measure: Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4
timeFrame: Baseline to Weeks 1, 2, 3 and 4
measure: Change in the BPI - Interference Scale From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in the BPI-Pain Scale From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4
timeFrame: Baseline to week 4
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Delta Clinical Research
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Fresno
country: United States
facility: Neuro-Pain Medical Cneter
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Tustin
country: United States
facility: Diabetes Research Center
state: California
city: Hamden
country: United States
facility: Chase Medical Research LLC
state: Connecticut
city: Lady Lake
country: United States
facility: Charter Research
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Miami
country: United States
facility: Coral Research Clinic Corp
state: Florida
city: Newnan
country: United States
facility: Better Health Clinical Reseach
state: Georgia
city: Evansville
country: United States
facility: Medisphere Medical Research Center
state: Indiana
city: Saint Peters
country: United States
facility: StudyMetrix Research LLC
state: Missouri
city: Las Vegas
country: United States
facility: Alliance for Multispeciality Research LLC
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: New York
country: United States
facility: IMA Clinical Research
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Clinton
country: United States
facility: Alpine Research Organization
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research LLC
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
References: