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

NCT04778592 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ETX-018810-201
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 24

Brief Summary

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

Conditions

Lumbosacral Radiculopathy

Outcome Measures

Primary Outcomes (1)

• 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)

  Change from baseline 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), a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).

  Baseline to Week 4

Secondary Outcomes (11)

• Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score

  Baseline to Weeks 1, 2, 3 and 4

• 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

  Baseline to Weeks 1, 2, 3 and 4

• Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3

  Baseline to Weeks 1, 2, and 3

• Change From Baseline to Week 4 for Worst Pain

  Baseline and Week 4

• Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4

  Week 4

Study Arms (2)

ETX-018810

EXPERIMENTAL

Drug: ETX-018810 BID for 4 weeks

Drug: ETX-018810

Placebo

PLACEBO COMPARATOR

Matching Placebo BID for 4 weeks

Drug: Placebo

Interventions

ETX-018810 DRUG

Study Drug

ETX-018810

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eliem Therapeutics (UK) Ltd.: lead

Study Sites (24)

Delta Clinical Research

Mobile, Alabama, 36606, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

DBPS Research LLC

Greenwood Village, Colorado, 80111, United States

Location

Charter Research

Lady Lake, Florida, 32159, United States

Location

Cordova Research Institute

Miami, Florida, 33155, United States

Location

Advanced Medical Research Institute

Miami, Florida, 33174, United States

Location

Coral Research Clinic Corp

Miami, Florida, 33186, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Better Health Clinical Research

Newnan, Georgia, 30265, United States

Location

Injury Care Research

Boise, Idaho, 83713, United States

Location

Chicago Anesthesia Research Specialist

Chicago, Illinois, 60657, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

University of Rochester Translational Pain Research

Rochester, New York, 14618, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Meta Medical Research Institute

Dayton, Ohio, 45432, United States

Location

Clinical Investigations LLC

Edmond, Oklahoma, 73013, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Precision Spine care

Tyler, Texas, 75701, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84107, United States

Location

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107, United States

Location

Northwest Clinical Research center

Bellevue, Washington, 98007, United States

Location

Results Point of Contact

• Title: Clinical Operations
• Organization: Eliem Therapeutics

studyinfo@eliemtx.com

+1-888-506-2573

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo Controlled

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: January 19, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 25, 2022
• Last Updated: November 7, 2023
• Results First Posted: June 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)