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

NCT ID: NCT04778592

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2022-05-25

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

Conditions

Lumbosacral Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ETX-018810

Drug: ETX-018810 BID for 4 weeks

Group Type: EXPERIMENTAL

ETX-018810

Intervention Type: DRUG

Study Drug

Placebo

Matching Placebo BID for 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

ETX-018810

Study Drug

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eliem Therapeutics (UK) Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Delta Clinical Research

Mobile, Alabama, United States

Arizona Research Center

Phoenix, Arizona, United States

DBPS Research LLC

Greenwood Village, Colorado, United States

Charter Research

Lady Lake, Florida, United States

Cordova Research Institute

Miami, Florida, United States

Advanced Medical Research Institute

Miami, Florida, United States

Coral Research Clinic Corp

Miami, Florida, United States

Drug Studies America

Marietta, Georgia, United States

Better Health Clinical Research

Newnan, Georgia, United States

Injury Care Research

Boise, Idaho, United States

Chicago Anesthesia Research Specialist

Chicago, Illinois, United States

Indiana Spine Group

Carmel, Indiana, United States

Healthcare Research Network

Hazelwood, Missouri, United States

Drug Trials America

Hartsdale, New York, United States

University of Rochester Translational Pain Research

Rochester, New York, United States

Center for Clinical Research

Winston-Salem, North Carolina, United States

Meta Medical Research Institute

Dayton, Ohio, United States

Clinical Investigations LLC

Edmond, Oklahoma, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Clinical Trials of South Carolina

Charleston, South Carolina, United States

Precision Spine care

Tyler, Texas, United States

Jean Brown Research

Salt Lake City, Utah, United States

Wasatch Clinical Research, LLC

Salt Lake City, Utah, United States

Northwest Clinical Research center

Bellevue, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ETX-018810-201

Identifier Type: -

Identifier Source: org_study_id