Sciatica Epidural Radiculopathy Experimental New Interventional TherapY Clonidine Micropellet

Inclusion Criteria:

1. Must be between 18 and 70 years of age (inclusive) at time the Informed Consent Form (ICF) is signed.
2. Must have a primary diagnosis of unilateral lumbar and/or lumbosacral radiculopathydefined by all of the following: supported by history, physical examination, andradiologic pathology consistent with a disc protrusion, non-sequestered extrusion, orsequestered fragment, as evidenced by magnetic resonance imaging (MRI), that isconsistent with the clinical signs and symptoms of lumbar or lumbosacralradiculopathy.
3. Subject's pain must have a radicular component (radiation into the leg along the L3-S1 [inclusive] dermatomal pattern) and may or may not be associated with additionalneuropathic features such as reduced sensory, motor, or deep tendon reflexes.
4. Worst radicular pain symptoms should be confined to a single dermatomal level asconfirmed on physical examination (to allow determination of injection level).
5. The NRS leg pain must be ≥4, must extend below the knee and be consistent withone of the dermatomal distributions noted above.
6. Radicular pain symptoms in the current episode must have been present for atleast 8 weeks, but not longer than 9 months at the time of Screening.
7. Subjects must not have had a significant reduction in the pain in the 1 to 2weeks before Screening (i.e., pain must not be improving significantly based onthe discretion of the Investigator).
8. Baseline 0-10 NRS average pain score localized to at least 1 target location must be ≥6 and ≤9.
9. Subjects must be able to separately distinguish and characterize the contribution ofback and leg pain to their overall pain to independently assess the response of eachto intervention. Investigators must confirm that subjects can do so based upon paindiagrams and direct questioning.
10. Subjects must have had no significant improvement following a minimum of 8 weeks ofthe following categories prior to Screening:
11. Mechanical intervention (eg, physical therapy, home exercise program, heatcompresses/massage, chiropractic treatment), and
12. Over-the-counter analgesics (non-steroidal anti-inflammatory drugs, topicalpatches/creams/gels/ointments).
13. Subjects of childbearing potential must have a negative (serum) pregnancy test atScreening and a negative urine pregnancy test within 24 hours before the injectionprocedure and must commit to either abstain continuously from sexual intercourse or touse, at the Investigator's discretion, highly effective birth control during the studyperiod.
14. Must sign an ICF indicating that they understand the purpose and any risks associatedwith the procedure required for the study and is willing to participate in the studyto completion.
15. Must be willing and able to adhere to the prohibitions and restrictions specified inthe protocol.
16. Must be able to read, write, understand, and complete study-related tasks, andadequately communicate regularly with the site.
17. Must have an email address and access to the internet from an electronic device inorder to complete daily EDQ information.

Exclusion Criteria:

1. Subject has significant pain unrelated to the lumbar or lumbosacral radiculopathy (eg,knee pain, hip pain, or rib pain) that, in the Investigator's opinion, could requirechronic analgesic treatment and interfere with the assessment of IP therapeuticeffect.
2. Subject has radiological findings or presenting features such as severe motor weakness (with or without reduced deep tendon reflexes) and is a candidate for surgicalreferral (i.e., progressive neurologic deficit or cauda equina syndrome).
3. Subject has evidence of pathology on MRI (obtained during the current episode of pain)that may result in pain unlikely to be addressed by the IP, including but not limitedto the following:
4. Symptomatic (eg, neurogenic claudication) radiographically confirmed centralstenosis at any level or diffuse spine pathology.
5. Non-inflammatory or bony lateral recess or foraminal stenosis such as that causedby facet hypertrophy or osteophytes that is a significant contributor to thecurrent episode of pain.
6. Spondylolisthesis > 3 mm at the level of the involved dermatome.
7. Evidence of a lumbar vertebral compression fracture, synovial cyst, lumbarepidural lipomatosis, or extraforaminal pathology.
8. Subject has a history of, or current diagnosis of, fibromyalgia.
9. Subject has a history of lumbar surgery and/or intradiscal interventions (includingdiscography).
10. Subject has an active infection (eg, fever or other objective evidence of an infectionwithin 7 days of the planned injection) or any skin condition visible at the injectionsite at time of Screening.
11. Subject has evidence of a coagulation abnormality or history of abnormal bleeding oris on anticoagulation therapy at time of Screening.
12. Subject has current untreated or clinically significant anxiety and/or depression asdefined by the following:
13. Beck Anxiety Inventory® (BAI®) score ≥29 or,
14. Beck Depression Inventory-2® (BDI®) score ≥31.
15. Changes in medications administered for treatment of depression or anxiety withinthe 30 days before Screening. Note: If a subject is taking antidepressant oranti-anxiety medication, either for the treatment of depression/anxiety or as ananalgesic adjunct, the subject must agree to maintain a stable dose (no change indosage) for the first 3 months of the study.
16. Subject is planning to receive a spinal injection or spine procedure whileparticipating in this study, unless this procedure can be postponed until studycompletion.
17. Subject has received an ESI, nerve block, or other similar procedure in thelumbosacral area performed during the 8 weeks prior to Screening.
18. Subject is receiving or has received the following medications prohibited in thisstudy:
19. Short-acting opioids taken as needed (PRN) less than 4 days a week (hydrocodone,oxycodone, tramadol, etc.) within 14 days prior to Screening.
20. Long-acting opioids or short-acting opioids taken regularly, i.e., more than 4days a week within 30 days prior to Screening.
21. Anticonvulsants for treatment of radicular leg pain if the dose has changed inthe 30 days prior to Screening or the subject is unable to maintain a stable dosefor the first 3 months of the study.
22. Systemic corticosteroids within the 30 days prior to Screening.
23. Central alpha-agents, including clonidine-containing medication ordexmedetomidine within 30 days before Screening.
24. Subject has a history of treatment, or has been recommended for treatment, of alcoholor drug use disorder treatment within the year prior to Screening.
25. Subject has a known or suspected allergy, hypersensitivity, or intolerance to any ofthe following:
26. Clonidine/clonidine hydrochloride.
27. Polylactic acid (found in products such as Lupron Depot®, Atridox®, some types ofdermal fillers, and some types of sutures).
28. Radiographic contrast agents or any other medications to be used during theprocedure.
29. Subject has recent (within previous 8 weeks) symptomatic hypotension, orthostatichypotension, or bradycardia.
30. Subject has a Body Mass Index (BMI) or a body habitus that, in the Investigator'sjudgment, would require a needle longer than a 3.5-inch Tuohy needle.
31. Subject has participated in a clinical trial of an investigational drug or devicewithin 30 days of Screening.
32. Subject has previously participated in a clinical trial sponsored by SollisTherapeutics (including Protocol Number STX-015-18-01 and Protocol NumberSTX-015-18-02).
33. Subject has any medical condition that, in the Investigator's opinion, could adverselyimpact study participation or safety, require chronic analgesic treatment, orinterfere with the pain assessments (eg, painful neuropathy, rheumatologic disorder,etc.).
34. Subject has worker's compensation benefits and/or is involved in any litigationrelated to his/her radicular pain.
35. Subject is currently pregnant or breast feeding, planning to become pregnant or, if ofchildbearing potential, is unwilling to have a pregnancy test administered or useappropriate, highly effective contraception.
36. Subject is unable or unwilling to undergo MRI examinations.
37. Subject is unable to adequately rate his/her pain in the EDQ.
38. Presence of active kidney disease, as evidenced by an estimated glomerular filtrationrate of less than 60 mL/min/1.73m2 utilizing the Chronic Kidney Disease EpidemiologyCollaboration equation.
39. Subjects will be excluded from randomization if they have any of the following duringthe 7-day Baseline Period:
40. Two or more ratings of NRS Average Leg Pain and/or Back Pain > 9 (showing severepain),
41. Two or more ratings of NRS Average Leg Pain and/or Back Pain ≥ 9 AND ≤ 3 (showinginconsistent pain).
42. Employees of Sollis Therapeutics, Novotech Health Holdings, or study site personneldirectly affiliated with this study, and their immediate family members. Immediatefamily is defined as a spouse, parent, child, or sibling, whether biological orlegally adopted.