Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain (NCT04778592) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
United States149 participantsStarted 2021-01-19
Plain-language summary
Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 disea…
What they're measuring
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)