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

Completed · Phase 2 · Has a placebo group

Conditions studied: Lumbosacral Radiculopathy

In brief

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

Key facts

Study ID

NCT04778592

Run by

Eliem Therapeutics (UK) Ltd.

People needed

149

Starts

2021-01-19

Expected to finish

2022-05-25

Last updated by the study team

2023-11-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.