Conditions: Diabetic Peripheral Neuropathic Pain Diabetic Peripheral Neuropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 167
Healthy volunteers: no

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).

Arms:
arm 1: 1000 mg BID for 4 weeks arm 2: matching placebo BID for 4 weeks

Interventions: intervention 1: ETX-018810 intervention 2: Placebo
Intervention descriptions: intervention 1: Study Drug intervention 2: Matching Placebo

Protocol document:
Prot_SAP_001.pdf: 
Synopsis ETX-018810-202 
 
ETX-018810 
 
 
Eliem Therapeutics (UK) Ltd 
 
Confidential 
Page 1 of 7 
Version 1.0, 07 July 2020 
 
 
 
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 
 
NCT Number: 04688671 
 
Document Date: 7th July 2020 
 
 
 












Synopsis ETX-018810-202 
 
ETX-018810 
 
 
Eliem Therapeutics (UK) Ltd 
 
Confidential 
Page 7 of 7 
Version 1.0, 07 July 2020 
 
The treatment comparison for the change from baseline at Week 4 was estimated using a Mixed 
Model Repeated Measures (MMRM), which included the baseline score as a covariate; treatment 
group, visit (week), and the treatment-by-visit (week) as fixed effects; and a repeated structure 
that acknowledged the visits within a subject using an unstructured covariance structure. The 
Kenward-Rogers (1997) approximation was used to estimate the denominator degrees of 
freedom. The estimate, standard error, 90% CI, and associated p-value (2-sided) were presented.