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

Sponsor

Eliem Therapeutics (UK) Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04778592

Collaborator

(none)

148

Enrollment

Location

Arms

15.5

Actual Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lumbosacral Radiculopathy	Drug: ETX-018810 Drug: Placebo	Phase 2

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

Study Design

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Placebo Controlled, Parallel-groupPlacebo Controlled, Parallel-group

Masking:

Double (Participant, Investigator)

Masking Description:

Double Blind Placebo Controlled

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Feb 5, 2021

Actual Primary Completion Date :

May 16, 2022

Actual Study Completion Date :

May 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ETX-018810 Drug: ETX-018810 bid	Drug: ETX-018810 Study Drug
Placebo Comparator: Placebo Matching Placebo bid	Drug: Placebo Placebo

Arm

Intervention/Treatment

Experimental: ETX-018810

Drug: ETX-018810 bid

Drug: ETX-018810

Study Drug

Placebo Comparator: Placebo

Matching Placebo bid

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Change from baseline to Week 4 in the weekly average of the daily pain score [Week 4]
Efficacy of ETX 018810 for the treatment of lumbosacral radicular pain will be assessed from change from baseline to Week 4 in the weekly average of the daily pain score on the 11 point Pain Intensity Numerical Rating Scale (PI NRS) from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Delta Clinical Research	Mobile	Alabama	United States	36606

Sponsors and Collaborators

Eliem Therapeutics (UK) Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eliem Therapeutics (UK) Ltd.

ClinicalTrials.gov Identifier:

NCT04778592

Other Study ID Numbers:

ETX-018810-201

First Posted:

Mar 3, 2021

Last Update Posted:

Jun 30, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Radiculopathy

Study Results

No Results Posted as of Jun 30, 2022