[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589561":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":11,"centralContacts":32,"locations":11,"responsibleParty":37,"collaborators":11,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":11,"enrollmentInfo":49,"targetDuration":11,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":11},{"fullName":5,"class":6},"Vertanical GmbH","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"VER-01 Dose 1","EXPERIMENTAL",null,[13],"Drug: VER-01",{"label":15,"type":10,"description":11,"interventionNames":16},"VER-01 Dose 2",[13],{"label":18,"type":19,"description":11,"interventionNames":20},"Placebo","PLACEBO_COMPARATOR",[21],"Other: Placebo",[23,28],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","VER-01","Standardized soft extract from Cannabis sativa DKJ127 L., cannabis flos (Cannabis flower), corresponding to 19 mg Δ9-Tetrahydrocannabinol (THC) per ml drug product",[9,15],{"type":29,"name":18,"description":30,"armGroupLabels":31,"otherNames":11},"OTHER","Comparator without active ingredient",[18],[33],{"name":5,"role":34,"phone":35,"phoneExt":11,"email":36},"CONTACT","+49 (0)89 787 97 90 - 0202","regulatory@vertanical.com",{"type":38,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100589561","phase-3-efficacy-and-safety-of-ver-01-in-the-treatment-of-participants-with-chronic-painful-lumbosacral-radiculopathy-100589561",false,"NCT06956014","Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy","Multicenter, Double-blind, Randomized, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of the Full-spectrum Cannabis Extract VER-01 in Participants With Chronic Painful Lumbosacral Radiculopathy","EXPAND","Inclusion Criteria:\n\n* Participants ≥ 18 years of age, all sexes\n* Participant voluntarily provided written informed consent\n* Participant is willing and able to comply with scheduled visits, treatment plan, eDiary, and other trial-related procedures throughout trial participation\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding female patients\n* Known history of previous or current severe psychiatric disorder as per DSM-5 (e.g., schizophrenia, bipolar disorder, severe anxiety disorder, psychotic disorder, post-traumatic stress disorder), or currently taking antipsychotic medication\n* Cardiovascular event or clinically significant cardiac dysfunction (e.g., congestive heart failure, myocardial ischemia, arrhythmias, poorly controlled high blood pressure, congenital long QT syndrome) within 12 months or a cardiac disorder that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction","ALL","18 Years",{"count":50,"type":51},810,"ESTIMATED","INTERVENTIONAL",[54],"PHASE3","The aim of the trial is to prove the efficacy and safety of VER-01 compared to placebo in patients with chronic painful lumbosacral radiculopathy (PLSR) for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.",[57],"Lumbosacral Radiculopathy","NOT_YET_RECRUITING","2026-06-22",{"date":61,"type":62},"2026-06-25","ACTUAL",{"date":64,"type":51},"2026-09",{"date":66,"type":51},"2028-09",{"name":5,"class":6}]