Sciatica Epidural Radiculopathy Experimental New Interventional TherapY Clonidine Micropellet

NCT05614648 | Terminated Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: STX-015-23-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 30

Brief Summary

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.

Conditions

Lumbosacral Radiculopathy

Outcome Measures

Primary Outcomes (3)

• Primary efficacy: Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D90 in lumbosacral radiculopathy.

  Difference in average pain score, using a scale of 0-10 with 0 no pain and 10 worst possible pain, from baseline to day 90.

  Baseline to day 90

• Incidence of Treatment-Emergent Adverse Events.

  Difference in incidence of adverse events and treatment due to radicular leg pain from Baseline to day 90 post injection based on physical examination findings and vital signs measurements.

  Baseline to day 90

• Incidence of symptomatic hypotension as an adverse event of special interest.

  Difference in incidence defined as low blood pressure associated with subject-reported symptoms of dizziness, lightheadedness, syncope, blurred vision, or nausea.

  Baseline to day 90

Secondary Outcomes (4)

• Change in Oswestry Disability Index (ODI) score

  Baseline to month12

• Difference in Rescue medication consumption.

  Baseline to month12

• Change in Average and Worst NRS from Day 90 post injection to 12 months post injection.

  from Day 90 to month 12 post injection

• Percent of subjects with significant improvement in pain.

  Baseline to day 90

Study Arms (2)

Clonidine Micropellets Injection

ACTIVE COMPARATOR

Clonidine Micropellets single dose injection into the lumbar epidural space

Drug: Clonidine Micropellets; Device: Tuohy epidural needle

Sham Insertion

SHAM COMPARATOR

Sham Control non-epidural needle placement

Device: Tuohy epidural needle

Interventions

Clonidine Micropellets DRUG

0.975 mg clonidine hydrochloride as 3 micropellets administered in one injection

Clonidine Micropellets Injection

Tuohy epidural needle DEVICE

18-gauge Tuohy epidural needle using a custom-built injector

Clonidine Micropellets Injection; Sham Insertion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Sollis Therapeutics, Inc.: lead

Study Sites (30)

Pima Pain Center (site 125)

Tucson, Arizona, 85711, United States

Location

University of Arizona/Banner (site 116)

Tucson, Arizona, 85711, United States

Location

Quality of Life Medical & Research Centers, LLC (site 127)

Tucson, Arizona, 85712, United States

Location

UCSD (site 124)

La Jolla, California, 92037, United States

Location

Nurovations/Napa Pain Institute (site 107)

Napa, California, 94558, United States

Location

International Spine, Pain & Performance Center (site 118)

Washington D.C., District of Columbia, 22205, United States

Location

Mocasa Wellness Center (site 119)

Miami, Florida, 33135, United States

Location

AMPM Research Clinic (site 106)

Miami, Florida, 33169, United States

Location

Florida Pain Relief Group (site 126)

Tampa, Florida, 33603, United States

Location

Conquest Research (site 142)

Winter Park, Florida, 32789, United States

Location

Injury Care Research (site 130)

Boise, Idaho, 83713, United States

Location

University of Kansas Medical Center (site 137)

Kansas City, Kansas, 66160, United States

Location

Neuroscience Research Center (site 105)

Overland Park, Kansas, 66210, United States

Location

Brigham and Women's Hospital (site 129)

Chestnut Hill, Massachusetts, 02467, United States

Location

St. Louis Pain Consultants (site 134)

Chesterfield, Missouri, 63017, United States

Location

Wake Forest Pain & Spine Specialists (site 112)

Clemmons, North Carolina, 27012, United States

Location

The Center for Clinical Research (site 101)

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic (site 121)

Cleveland, Ohio, 44106, United States

Location

University Hospitals (site 131)

Cleveland, Ohio, 44106, United States

Location

Clinical Investigations LLC (site 103)

Edmond, Oklahoma, 73013, United States

Location

Pacific Sports and Spine, LLC (site 133)

Eugene, Oregon, 97401, United States

Location

Clinical Trials of South Carolina (site 114)

Charleston, South Carolina, 29406, United States

Location

HRMD Research (site 102)

Dallas, Texas, 75240, United States

Location

UT Southwestern (site 140)

Dallas, Texas, 75390, United States

Location

NCP Clinical Research (site 141)

Houston, Texas, 77008, United States

Location

Texas Pain Consultant Associates (site 110)

Sugar Land, Texas, 77479, United States

Location

ARH Research, LLC (site 108)

The Woodlands, Texas, 77382, United States

Location

Space City Pain (site 135)

Webster, Texas, 77598, United States

Location

Physicians' Research Options (site 122)

Draper, Utah, 84020, United States

Location

CenExel JBR Clinical Research (site 113)

Salt Lake City, Utah, 84107, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clonidine Micropellet vs Sham-Control

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 14, 2022
• Study Start: June 19, 2023
• Primary Completion: March 18, 2024
• Study Completion: March 30, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)