NCT04688671

Efficacy and Safety of ETX-018810 for the Treatment of 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Eliem Therapeutics (UK) Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetic Peripheral Neuropathic Pain
• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	ETX-018810	Study Drug
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2020-11-09
• Primary completion: 2022-02-09
• Completion: 2022-02-18
• First posted: 2020-12-30
• Last updated: 2023-11-07
• Results posted: 2023-05-16

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study