Phase 2 N=149 Randomized Double-blind Treatment

Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain

Lumbosacral Radiculopathy

Bottom Line

View on ClinicalTrials.gov: NCT04778592 ↗

Enrolled (actual)

149

Serious AEs

0.7%

Results posted

Jun 2023

Primary outcome: Primary: 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) — -1.49; -1.65 units on a scale — p=0.4549

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ETX-018810 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eliem Therapeutics (UK) Ltd.
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY 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)	-1.49; -1.65	0.4549
SECONDARY Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score	4; 3; 9; 8; 12; 17	—
SECONDARY 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	9; 17; 18; 19; 22; 28	—
SECONDARY Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3	-0.66; -0.85; -1.04; -1.15; -1.28; -1.49	—
SECONDARY Change From Baseline to Week 4 for Worst Pain	-1.73; -1.74	—
SECONDARY Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4	23; 25	—
SECONDARY Number of Subjects With a CGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4	21; 24	—
SECONDARY Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4	-0.87; -0.81; -1.14; -1.18; -1.41; -1.51	—
SECONDARY Change in BPI - Interference Scale From Baseline to Week 4	-1.68; -1.94	—
SECONDARY Change in the BPI - Pain Scale From Baseline to Week 4	-1.70; -1.57	—
SECONDARY Change in the RMDQ From Baseline to Week 4	-2.10; -2.31	—
SECONDARY Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4	0; 0	—

Summary

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

Eligibility Criteria

Inclusion Criteria

The subject has pain consistent with a diagnosis of chronic lumbosacral radiculopathy due to injury of the lumbosacral nerve root(s)
The subject reports at least moderate pain intensity at screening.
The subject's onset of leg pain due to LSRP is at least 3 months
The subject has a magnetic resonance imaging (MRI) scan that is normal or shows incidental lesions
The subject has a calculated creatinine clearance ≥30 mL/min
The subject has clinical laboratory values within normal limits or abnormal values that the investigator deems not clinically significant.
body mass index (BMI) <40 kg/m2.

Exclusion Criteria

The subject has previously undergone back surgery
The subject is unable to reliably delineate or assess pain by anatomical location/distribution on a body map.
The subject has a history of peripheral neuropathy, evidence of peripheral neuropathy, or evidence of mononeuropathy in the same limb of LSRP.
The subject has pain due to infection/abscess, hematoma, or malignancy or other pain that may interfere with the assessment of LSRP in the legs.
The subject has clinically significant and/or unstable renal, hepatic, hematologic, endocrine, immunologic, inflammatory/rheumatologic, respiratory, or cardiovascular disease that would compromise participation in the study
The subject has any neurological disease that could interfere with participation in the study (e.g., Huntington's disease, Parkinson's disease, Alzheimer's disease, multiple sclerosis, seizures, epilepsy, stroke).
The subject has a history or current diagnosis of major psychiatric disorder(s)
The subject has a has a history of substance abuse or dependence
The subject has clinically significant abnormal electrocardiogram (ECG) findings
The subject has received nerve blocks and/or steroid injections for LSRP within the 3 months before screening
The subject is unwilling or unable to discontinue current medications for LSRP, including topical agents.
The subject is unable to refrain from using prohibited meds during the study, including: NSAID, antiepileptic drugs, steroids, cannabinoids, or major opioids, antidepressants, muscle relaxants, tramadol, or tapentadol.
The subject has used prohibited nonpharmacologic therapies, including acupuncture, transcutaneous electrical nerve stimulation, within 30 days the study.
The subject is currently participating in another or the same clinical study or participated in another clinical study within 3 months before screening
The subject is pregnant or lactating or not practicing adequate birth control

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04778592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.