Conditions: Lumbosacral Radiculopathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 149
Healthy volunteers: no

Brief summary:
Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain

Detailed description:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain

Arms:
arm 1: Drug: ETX-018810 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: Placebo

Protocol document:
Prot_SAP_000.pdf: 
Protocol ETX-018810-201 
 
ETX-018810 
 
 
Eliem Therapeutics (UK) Ltd 
 
Confidential 
Page 1 of 7 
Version 2.0, 24 May 2021 
 
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the 
Efficacy and Safety of ETX-018810 in Subjects with Lumbosacral Radicular Pain 
 
NCT Number: 04778592 
 
Document Date: 24th May 2021 
 












Protocol ETX-018810-201 
 
ETX-018810 
 
 
Eliem Therapeutics (UK) Ltd 
 
Confidential 
Page 7 of 7 
Version 2.0, 24 May 2021 
 
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.