Status:
COMPLETED
Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
Lead Sponsor:
Eliem Therapeutics (UK) Ltd.
Conditions:
Lumbosacral Radiculopathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain
Detailed 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2022
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT04778592
Start Date
January 19 2021
End Date
May 25 2022
Last Update
November 7 2023
Active Locations (24)
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1
Delta Clinical Research
Mobile, Alabama, United States, 36606
2
Arizona Research Center
Phoenix, Arizona, United States, 85053
3
DBPS Research LLC
Greenwood Village, Colorado, United States, 80111
4
Charter Research
Lady Lake, Florida, United States, 32159