[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sciatic-radiculopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sciatic-radiculopathy":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100613260",false,"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.","ALL","18 Years","65 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"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",[26,27,28,29,30,31],"Lumbosacral Radicular Pain","Sciatic Radiculopathy","Sciatic Leg Pain","Sciatica","Lumbosacral Radicular Syndrome","Lumbosacral Radiculopathy",[29,33,34,35,31,36,37,38],"Sciatic Nerve Pain","LSR","back pain","Chronic Painful Lumbosacral Radiculopathy","non-opioid pain medication","transforaminal epidural injection","RECRUITING","2026-03-16",{"date":42,"type":43},"2026-03-17","ACTUAL",{"date":45,"type":43},"2025-12-03",{"date":47,"type":20},"2026-12-01",{"name":49,"class":50},"Consano Bio","INDUSTRY",3,{"id":53,"slug":4,"hasResults":10,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":5},"100356729","NCT03924791","Transforaminal Epidural Injection in Acute Sciatica","TEIAS","Inclusion Criteria:\n\n* Diagnosed with sciatica by GP\n* NRS leg pain of 6 or more on a 10-point NRS scale\n* Minimum duration of symptoms of 3 weeks and maximum duration of 8 weeks\n\nExclusion Criteria:\n\n* Age under 18 years\n* Condition preventing to receive transforaminal epidural injection\n* Severe scoliosis\n* Transforaminal epidural injection received in 6 months before randomization date\n* Surgery for sciatica at the same level\n* Surgery for sciatica at another level within one year before inclusion\n* Pregnancy",{"count":59,"type":20},142,[61],"NA","Patients suffering from sciatica are treated conservatively for the first 8 weeks due to the favourable prognosis. This period is preferably extended up to 14-16 weeks after which patients may opt for surgery. However, patients may experience severe discomfort due to pain in the leg which can lead to decreased physical activity and socio-economic problems. An adequate therapy to alleviate symptoms during this period of 'wait-and-see' is lacking. In this study, patients will be randomized to treatment with transforaminal epidural injections or standard oral pain medication.",[29,64,27],"Sciatica Due to Intervertebral Disc Disorder",[29,66,67,68,69,70,71,72,73],"Acute sciatica","Transforaminal epidural injection","Leg pain","Lumbar spine","Back pain","Lumbar surgery","Herniated intervertebral lumbar disk","Cost-effectiveness","2023-10-18",{"date":76,"type":43},"2023-10-19",{"date":78,"type":43},"2019-06-01",{"date":80,"type":20},"2026-07",{"name":82,"class":83},"C.L.A.Vleggeert-Lankamp","OTHER",""]