Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
NCT ID:
NCT04778592
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04778592
Study Brief:
Protocol Section:
NCT04778592