[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lumbosacral-radicular-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lumbosacral-radicular-pain":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100639142","phase-3-corticosteroid-lumbar-epidural-analgesia-for-radicular-pain-2-100639142",false,"NCT07579351","Corticosteroid Lumbar Epidural Analgesia for Radicular Pain 2","Corticosteroid Lumbar Epidural Analgesia for Radicular Pain (C.L.E.A.R) 2 - A Randomized, Double-blind, Active Comparator and Placebo-controlled, Multicenter, Safety and Efficacy Trial of SP-102","CLEAR 2","Inclusion Criteria:\n\nMain Inclusion Criteria:\n\n* Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures.\n* Age 18 to 75 years (inclusive) at the Screening Visit.\n* A diagnosis of lumbosacral radicular pain (sciatica) present for at least 6 weeks and not more than 9 months prior to the Screening Visit.\n* Clinical symptoms consistent with the imaging (MRI)\n* Agrees to follow study-specific medication requirements.\n* If sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study.\n* Has reviewed all study specific materials and has, in the opinion of the Investigator, the abilities to understand and appropriately complete all study procedures.\n\nDay 1 Inclusion:\n\nAs calculated by the eDiary system, during the 7 days (D-7 to D-1) immediately prior to the Baseline Visit, the participant:\n\n1. Completed the current, worst, and daily average NPRS scores (in the affected leg, non-affected leg, and lower back) in the eDiary on at least 6 out of the 7 days during the Baseline Period.\n2. Meets the NPRS average daily pain score criteria,\n3. Has a mean (at Baseline Visit) NPRS worst pain score in the affected leg that is greater than the mean worst pain score in lower back.\n\nParticipant continues to demonstrate a clear understanding of how to complete the eDiary.\n\nParticipant remains an appropriate candidate for trial participation in the opinion of the Investigator.\n\nParticipant continues to meet all the screening inclusion criteria and none of the exclusion criteria. -\n\nExclusion Criteria:\n\n* Has a body mass index ≥40 kg\u002Fm2.\n* Has radiologic evidence of a condition that would compromise study outcomes:\n\nSpinal cord tumor (intra- or extradural) or hematoma. Epidural or intrathecal abscess. Systemic infection.\n\n* Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study.\n* Has been diagnosed with insulin dependent diabetes mellitus.\n* Presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the Investigator, has the potential to prevent study completion and\u002For to have a confounding effect on outcome assessments.\n* Use of any investigational drug and\u002For device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study.\n* Has any contradiction to performing MRI (such as coronary pacemakers and implantable cardioverter-defibrillators \\[ICDs\\], metallic foreign bodies, neuro and spinal cord stimulators).\n* Has history of malignancy or evidence of malignancy, within 5 years of Screening Visit.\n* Has significant motor impairment\n* Has regular use of opioid doses \\> 30 mg morphine equivalents per day for more than 2 days per week in the 30 days prior to the Screening Visit.\n* Involvement in an ongoing worker's compensation claim, disability claim, or litigation related to any pain problem, receiving payments for a settled claim, awaiting pending payment for a settled claim, or any potential secondary gain in the opinion of the Investigator.","ALL","18 Years","75 Years",{"count":21,"type":22},755,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a research study of SP-102, an experimental medication designed to relieve pain in patients with moderate to severe sciatica (pain in the lower back, hips, buttocks and legs). SP-102, placebo (a medication that looks like SP-102 but does not contain any active ingredient), or an active comparator (dexamethasone sodium phosphate) is given once by the participant's healthcare professional. If a participant meets qualifications, each participant will have the option of receiving one supplemental open-label injection of SP-102, greater than four weeks and up to twenty weeks after their first injection.\n\nThe purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain versus placebo. The study will also measure how well SP-102 relieves pain versus an active comparator medication (dexamethasone sodium phosphate). The study will also investigate the side effects of SP-102.",[28],"Lumbosacral Radicular Pain",[28,30,31],"Sciatica","Leg Pain","NOT_YET_RECRUITING","2026-05-06",{"date":35,"type":36},"2026-05-12","ACTUAL",{"date":38,"type":22},"2026-08",{"date":40,"type":22},"2029-01",{"name":42,"class":43},"Semnur Pharmaceuticals, Inc.","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100613260","phase-1-study-to-evaluate-safety-of-c-1101-versus-sterile-saline-in-adults-with-chronic-painful-lumbosacral-radiculopathy-100613260","NCT07264270","Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy","A Phase 1, Randomized, Double-Blind, Single Dose Escalation Study to Assess the Safety and Tolerability of Transforaminal Epidural Administration of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy","Inclusion Criteria:\n\n* Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care\n* Body mass index \\\u003C 35 kg\u002Fm2.\n\nExclusion Criteria:\n\n* Presence of clinically significant disease or any other painful condition that may interfere with assessments.\n* Any condition that currently requires blood or platelet transfusions.\n* Diagnosed with schizophrenia, bipolar disorder, or major depressive disorder.\n* Increased risk of bleeding or is taking anticoagulants or platelet aggregation inhibitors.\n* History or presence of autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathies.\n* History of myocardial infarction within the last 6 months or congestive heart failure.\n* The presence of an active malignancy or tumor.\n* Have undergone a surgical procedure for back pain.\n* Recent use of immunosuppressants, oral steroids, or intravenous steroids.","65 Years",{"count":53,"type":22},24,[55],"PHASE1","The purpose of this study is to evaluate the safety and tolerability of C-1101 administered as a single dose, transforaminal epidural injection compared to sterile saline",[28,58,59,30,60,61],"Sciatic Radiculopathy","Sciatic Leg Pain","Lumbosacral Radicular Syndrome","Lumbosacral Radiculopathy",[30,63,64,65,61,66,67,68],"Sciatic Nerve Pain","LSR","back pain","Chronic Painful Lumbosacral Radiculopathy","non-opioid pain medication","transforaminal epidural injection","RECRUITING","2026-03-16",{"date":72,"type":36},"2026-03-17",{"date":74,"type":36},"2025-12-03",{"date":76,"type":22},"2026-12-01",{"name":78,"class":43},"Consano Bio",3]