Sciatica Epidural Radiculopathy Experimental New Interventional TherapY Clonidine Micropellet
Stopped: Loss of funding- Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
United States17 participantsStarted 2023-06-19
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕
What they're measuring
1
Primary efficacy: Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D90 in lumbosacral radiculopathy.
Timeframe: Baseline to day 90
2
Incidence of Treatment-Emergent Adverse Events.
Timeframe: Baseline to day 90
3
Incidence of symptomatic hypotension as an adverse event of special interest.
. 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.