[{"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":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100613260","phase-1-study-to-evaluate-safety-of-c-1101-versus-sterile-saline-in-adults-with-chronic-painful-lumbosacral-radiculopathy-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":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28,29,30,31,32],"Lumbosacral Radicular Pain","Sciatic Radiculopathy","Sciatic Leg Pain","Sciatica","Lumbosacral Radicular Syndrome","Lumbosacral Radiculopathy",[30,34,35,36,32,37,38,39],"Sciatic Nerve Pain","LSR","back pain","Chronic Painful Lumbosacral Radiculopathy","non-opioid pain medication","transforaminal epidural injection","RECRUITING","2026-03-16",{"date":43,"type":44},"2026-03-17","ACTUAL",{"date":46,"type":44},"2025-12-03",{"date":48,"type":21},"2026-12-01",{"name":50,"class":51},"Consano Bio","INDUSTRY",3,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":5},"100356729","transforaminal-epidural-injection-in-acute-sciatica-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":61,"type":21},142,[63],"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.",[30,66,28],"Sciatica Due to Intervertebral Disc Disorder",[30,68,69,70,71,72,73,74,75],"Acute sciatica","Transforaminal epidural injection","Leg pain","Lumbar spine","Back pain","Lumbar surgery","Herniated intervertebral lumbar disk","Cost-effectiveness","2023-10-18",{"date":78,"type":44},"2023-10-19",{"date":80,"type":44},"2019-06-01",{"date":82,"type":21},"2026-07",{"name":84,"class":85},"C.L.A.Vleggeert-Lankamp","OTHER"]