Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
Condition: Lumbosacral Radiculopathy
MeSH terms: Radiculopathy
Intervention: ETX-018810; Placebo
Intervention description: Study Drug; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo Controlled
Masking: Double (Participant, Investigator)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

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

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