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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Peripheral Neuropathic Pain, Diabetic Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT04688671

Run by

Eliem Therapeutics (UK) Ltd.

People needed

167

Starts

2020-11-09

Expected to finish

2022-02-18

Last updated by the study team

2023-11-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• Medisphere Medical Research Center — Evansville, Indiana, United States
• StudyMetrix Research LLC — City of Saint Peters, Missouri, United States
• Alliance for Multispeciality Research LLC — Las Vegas, Nevada, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• IMA Clinical Research — New York, New York, United States
• Upstate Clinical Research Associates — Williamsville, New York, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• FutureSearch Trials of Neurology — Austin, Texas, United States
• Alpine Research Organization — Clinton, Utah, United States
• Jean Brown Research — Salt Lake City, Utah, United States
• Wasatch Clinical Research LLC — Salt Lake City, Utah, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.