Sciatica Epidural Radiculopathy Experimental New Interventional TherapY Clonidine Micropellet

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Lumbosacral Radiculopathy

In brief

This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. Participants will receive a single injection of either clonidine micropellet or sham injection for the treatment of low back and leg pain from sciatica.

Key facts

Study ID

NCT05614648

Run by

Sollis Therapeutics, Inc.

People needed

17

Starts

2023-06-19

Expected to finish

2024-03-30

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be between 18 and 70 years of age (inclusive) at time the Informed Consent Form (ICF) is signed.
• 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.
• 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.
• Worst radicular pain symptoms should be confined to a single dermatomal level as confirmed on physical examination (to allow determination of injection level).
• The NRS leg pain must be ≥4, must extend below the knee and be consistent with one of the dermatomal distributions noted above.
• 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.
• 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).
• Baseline 0-10 NRS average pain score localized to at least 1 target location must be ≥6 and ≤9.
• 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.
• Subjects must have had no significant improvement following a minimum of 8 weeks of the following categories prior to Screening:
• Mechanical intervention (eg, physical therapy, home exercise program, heat compresses/massage, chiropractic treatment), and
• Over-the-counter analgesics (non-steroidal anti-inflammatory drugs, topical patches/creams/gels/ointments).
• 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.
• 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.
• Must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
• Must be able to read, write, understand, and complete study-related tasks, and adequately communicate regularly with the site.
• Must have an email address and access to the internet from an electronic device in order to complete daily EDQ information.

You may not qualify if…

• 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.
• 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).
• 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:
• Symptomatic (eg, neurogenic claudication) radiographically confirmed central stenosis at any level or diffuse spine pathology.
• 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.
• Spondylolisthesis > 3 mm at the level of the involved dermatome.
• Evidence of a lumbar vertebral compression fracture, synovial cyst, lumbar epidural lipomatosis, or extraforaminal pathology.
• Subject has a history of, or current diagnosis of, fibromyalgia.
• Subject has a history of lumbar surgery and/or intradiscal interventions (including discography).
• 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.
• Subject has evidence of a coagulation abnormality or history of abnormal bleeding or is on anticoagulation therapy at time of Screening.
• Subject has current untreated or clinically significant anxiety and/or depression as defined by the following:
• Beck Anxiety Inventory® (BAI®) score ≥29 or,
• Beck Depression Inventory-2® (BDI®) score ≥31.
• 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.
• 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.
• Subject has received an ESI, nerve block, or other similar procedure in the lumbosacral area performed during the 8 weeks prior to Screening.
• Subject is receiving or has received the following medications prohibited in this study:
• Short-acting opioids taken as needed (PRN) less than 4 days a week (hydrocodone, oxycodone, tramadol, etc.) within 14 days prior to Screening.
• Long-acting opioids or short-acting opioids taken regularly, i.e., more than 4 days a week within 30 days prior to Screening.
• 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.
• Systemic corticosteroids within the 30 days prior to Screening.
• Central alpha-agents, including clonidine-containing medication or dexmedetomidine within 30 days before Screening.
• 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.
• Subject has a known or suspected allergy, hypersensitivity, or intolerance to any of the following:

Where it is running

• Pima Pain Center (site 125) — Tucson, Arizona, United States
• University of Arizona/Banner (site 116) — Tucson, Arizona, United States
• Quality of Life Medical & Research Centers, LLC (site 127) — Tucson, Arizona, United States
• UCSD (site 124) — La Jolla, California, United States
• Nurovations/Napa Pain Institute (site 107) — Napa, California, United States
• International Spine, Pain & Performance Center (site 118) — Washington D.C., District of Columbia, United States
• Mocasa Wellness Center (site 119) — Miami, Florida, United States
• AMPM Research Clinic (site 106) — Miami, Florida, United States
• Florida Pain Relief Group (site 126) — Tampa, Florida, United States
• Conquest Research (site 142) — Winter Park, Florida, United States
• Injury Care Research (site 130) — Boise, Idaho, United States
• University of Kansas Medical Center (site 137) — Kansas City, Kansas, United States
• Neuroscience Research Center (site 105) — Overland Park, Kansas, United States
• Brigham and Women's Hospital (site 129) — Chestnut Hill, Massachusetts, United States
• St. Louis Pain Consultants (site 134) — Chesterfield, Missouri, United States
• Wake Forest Pain & Spine Specialists (site 112) — Clemmons, North Carolina, United States
• The Center for Clinical Research (site 101) — Winston-Salem, North Carolina, United States
• Cleveland Clinic (site 121) — Cleveland, Ohio, United States
• University Hospitals (site 131) — Cleveland, Ohio, United States
• Clinical Investigations LLC (site 103) — Edmond, Oklahoma, United States
• Pacific Sports and Spine, LLC (site 133) — Eugene, Oregon, United States
• Clinical Trials of South Carolina (site 114) — Charleston, South Carolina, United States
• HRMD Research (site 102) — Dallas, Texas, United States
• UT Southwestern (site 140) — Dallas, Texas, United States
• NCP Clinical Research (site 141) — Houston, Texas, United States

Full record on ClinicalTrials.gov

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