| Eligibility |
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 radiculopathy
defined by all of the following: supported by history, physical examination, and
radiologic pathology consistent with a disc protrusion, non-sequestered extrusion, or
sequestered fragment, as evidenced by magnetic resonance imaging (MRI), that is
consistent with the clinical signs and symptoms of lumbar or lumbosacral
radiculopathy.
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 additional
neuropathic features such as reduced sensory, motor, or deep tendon reflexes.
1. Worst radicular pain symptoms should be confined to a single dermatomal level as
confirmed on physical examination (to allow determination of injection level).
2. The NRS leg pain must be =4, must extend below the knee and be consistent with
one of the dermatomal distributions noted above.
3. Radicular pain symptoms in the current episode must have been present for at
least 8 weeks, but not longer than 9 months at the time of Screening.
4. Subjects must not have had a significant reduction in the pain in the 1 to 2
weeks before Screening (i.e., pain must not be improving significantly based on
the discretion of the Investigator).
4. Baseline 0-10 NRS average pain score localized to at least 1 target location must be
=6 and =9.
5. Subjects must be able to separately distinguish and characterize the contribution of
back and leg pain to their overall pain to independently assess the response of each
to intervention. Investigators must confirm that subjects can do so based upon pain
diagrams and direct questioning.
6. Subjects must have had no significant improvement following a minimum of 8 weeks of
the following categories prior to Screening:
1. Mechanical intervention (eg, physical therapy, home exercise program, heat
compresses/massage, chiropractic treatment), and
2. Over-the-counter analgesics (non-steroidal anti-inflammatory drugs, topical
patches/creams/gels/ointments).
7. Subjects of childbearing potential must have a negative (serum) pregnancy test at
Screening and a negative urine pregnancy test within 24 hours before the injection
procedure and must commit to either abstain continuously from sexual intercourse or to
use, at the Investigator's discretion, highly effective birth control during the study
period.
8. Must sign an ICF indicating that they understand the purpose and any risks associated
with the procedure required for the study and is willing to participate in the study
to completion.
9. Must be willing and able to adhere to the prohibitions and restrictions specified in
the protocol.
10. Must be able to read, write, understand, and complete study-related tasks, and
adequately communicate regularly with the site.
11. Must have an email address and access to the internet from an electronic device in
order 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 require
chronic analgesic treatment and interfere with the assessment of IP therapeutic
effect.
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 surgical
referral (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 limited
to the following:
1. Symptomatic (eg, neurogenic claudication) radiographically confirmed central
stenosis at any level or diffuse spine pathology.
2. Non-inflammatory or bony lateral recess or foraminal stenosis such as that caused
by facet hypertrophy or osteophytes that is a significant contributor to the
current episode of pain.
3. Spondylolisthesis > 3 mm at the level of the involved dermatome.
4. Evidence of a lumbar vertebral compression fracture, synovial cyst, lumbar
epidural lipomatosis, or extraforaminal pathology.
4. Subject has a history of, or current diagnosis of, fibromyalgia.
5. Subject has a history of lumbar surgery and/or intradiscal interventions (including
discography).
6. Subject has an active infection (eg, fever or other objective evidence of an infection
within 7 days of the planned injection) or any skin condition visible at the injection
site at time of Screening.
7. Subject has evidence of a coagulation abnormality or history of abnormal bleeding or
is on anticoagulation therapy at time of Screening.
8. Subject has current untreated or clinically significant anxiety and/or depression as
defined by the following:
1. Beck Anxiety Inventory® (BAI®) score =29 or,
2. Beck Depression Inventory-2® (BDI®) score =31.
3. Changes in medications administered for treatment of depression or anxiety within
the 30 days before Screening. Note: If a subject is taking antidepressant or
anti-anxiety medication, either for the treatment of depression/anxiety or as an
analgesic adjunct, the subject must agree to maintain a stable dose (no change in
dosage) for the first 3 months of the study.
9. Subject is planning to receive a spinal injection or spine procedure while
participating in this study, unless this procedure can be postponed until study
completion.
10. Subject has received an ESI, nerve block, or other similar procedure in the
lumbosacral area performed during the 8 weeks prior to Screening.
11. Subject is receiving or has received the following medications prohibited in this
study:
1. Short-acting opioids taken as needed (PRN) less than 4 days a week (hydrocodone,
oxycodone, tramadol, etc.) within 14 days prior to Screening.
2. Long-acting opioids or short-acting opioids taken regularly, i.e., more than 4
days a week within 30 days prior to Screening.
3. Anticonvulsants for treatment of radicular leg pain if the dose has changed in
the 30 days prior to Screening or the subject is unable to maintain a stable dose
for the first 3 months of the study.
4. Systemic corticosteroids within the 30 days prior to Screening.
5. Central alpha-agents, including clonidine-containing medication or
dexmedetomidine within 30 days before Screening.
12. Subject has a history of treatment, or has been recommended for treatment, of alcohol
or drug use disorder treatment within the year prior to Screening.
13. Subject has a known or suspected allergy, hypersensitivity, or intolerance to any of
the following:
1. Clonidine/clonidine hydrochloride.
2. Polylactic acid (found in products such as Lupron Depot®, Atridox®, some types of
dermal fillers, and some types of sutures).
3. Radiographic contrast agents or any other medications to be used during the
procedure.
14. Subject has recent (within previous 8 weeks) symptomatic hypotension, orthostatic
hypotension, or bradycardia.
15. Subject has a Body Mass Index (BMI) or a body habitus that, in the Investigator's
judgment, would require a needle longer than a 3.5-inch Tuohy needle.
16. Subject has participated in a clinical trial of an investigational drug or device
within 30 days of Screening.
17. Subject has previously participated in a clinical trial sponsored by Sollis
Therapeutics (including Protocol Number STX-015-18-01 and Protocol Number
STX-015-18-02).
18. Subject has any medical condition that, in the Investigator's opinion, could adversely
impact study participation or safety, require chronic analgesic treatment, or
interfere with the pain assessments (eg, painful neuropathy, rheumatologic disorder,
etc.).
19. Subject has worker's compensation benefits and/or is involved in any litigation
related to his/her radicular pain.
20. Subject is currently pregnant or breast feeding, planning to become pregnant or, if of
childbearing potential, is unwilling to have a pregnancy test administered or use
appropriate, highly effective contraception.
21. Subject is unable or unwilling to undergo MRI examinations.
22. Subject is unable to adequately rate his/her pain in the EDQ.
23. Presence of active kidney disease, as evidenced by an estimated glomerular filtration
rate of less than 60 mL/min/1.73m2 utilizing the Chronic Kidney Disease Epidemiology
Collaboration equation.
24. Subjects will be excluded from randomization if they have any of the following during
the 7-day Baseline Period:
1. Two or more ratings of NRS Average Leg Pain and/or Back Pain > 9 (showing severe
pain),
2. Two or more ratings of NRS Average Leg Pain and/or Back Pain = 9 AND = 3 (showing
inconsistent pain).
25. Employees of Sollis Therapeutics, Novotech Health Holdings, or study site personnel
directly affiliated with this study, and their immediate family members. Immediate
family is defined as a spouse, parent, child, or sibling, whether biological or
legally adopted.
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