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

Eliem Therapeutics

Status and phase: Completed; Phase 2

Conditions: Lumbosacral Radiculopathy

Treatments: Drug: Placebo; Drug: ETX-018810

Study type: Interventional

Funder types: Industry

Identifiers

NCT04778592

ETX-018810-201

Details and patient eligibility

About

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

Full 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

Enrollment: 149 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

149 participants in 2 patient groups, including a placebo group

ETX-018810

Experimental group

Description:

Drug: ETX-018810 BID for 4 weeks

Treatment:

Drug: ETX-018810

Placebo

Placebo Comparator group

Description:

Matching Placebo BID for 4 weeks

Treatment:

Drug: Placebo