[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553733":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":36,"responsibleParty":38,"collaborators":41,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":36,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":36,"enrollmentInfo":54,"targetDuration":36,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":69,"whyStopped":36,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":36},{"fullName":5,"class":6},"University Hospital Sestre Milosrdnice","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cerebrolysin group","EXPERIMENTAL","Patients with acute basilar artery occlusion who meet the eligibility criteria will receive Cerebrolysin in a single-day dosage of 30 ml, diluted with 250 ml of 0.9% saline intravenously in the first 24 hours after the stroke. Cerebrolysin will be further administered in the same dosage once daily in the morning for 14 consecutive days.",[13],"Drug: Cerebrolysin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Cerebrolysin","The Cerebrolysin will be administered at least one hour after the standard treatment and no later than 24 hours after the stroke symptom onset.",[9],[21],"Cerebrolysin®",[23],{"name":24,"affiliation":25,"role":26},"Marina Roje Bedeković, MD, PhD","Sestre milosrdnice University Hospital Center","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Marina Roje bedeković, MD, PhD","CONTACT","0993787257","+385","marina.roje.bedekovic@kbcsm.hr",{"name":35,"role":30,"phone":36,"phoneExt":36,"email":37},"Ivona Jerković, MD",null,"ivona.jerkovic@kbcsm.hr",{"type":26,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Marina Roje Bedekovic","Professor Marina Roje Bedeković, MD, PhD, neurologist",[42],{"name":43,"class":44},"Ever Neuro Pharma GmbH","INDUSTRY","100553733","early-phase-1-cerebrolysin-as-an-add-on-therapy-to-standard-treatment-of-basilar-artery-occlusion-100553733",false,"NCT06489925","Cerebrolysin as an Add-On Therapy to Standard Treatment of Basilar Artery Occlusion","Cerebrolysin as an Add-On Therapy to Standard Treatment of Posterior Circulation Stroke Secondary to Basilar Artery Occlusion","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Acute basilar artery occlusion confirmed on MSCT\u002F MR angiography\n* Premorbid mRS ≤ 3\n* Signed written consent\n\nExclusion Criteria:\n\n* Hypersensitivity to one of the components of the drug\n* Breastfeeding and pregnancy\n* Epilepsy, epileptic seizure\n* Severe renal impairment (grade IV and V)\n* Ischemic stroke in the previous three months\n* Metastatic cancer\n* Sepsis or a severe infection on admission\n* Acute coronary syndrome, pulmonary embolism, and deep venous thrombosis on admission","ALL","18 Years",{"count":55,"type":56},20,"ESTIMATED","INTERVENTIONAL",[59],"EARLY_PHASE1","The standard therapy for acute ischemic posterior circulation stroke (PCS) often leads to poor functional outcomes and high mortality rates, despite all advances in reperfusion therapy. Recent trials have shown that adding Cerebrolysin, a cerebral neuroprotective agent, to standard therapy for patients with acute ischemic anterior circulation stroke is safe and leads to improved functional outcomes. The purpose of this study is to assess the effectiveness and safety of Cerebrolysin with standard treatment for patients with PCS secondary to basilar artery occlusion (BAO).\n\nThe plan is to conduct a prospective, single-center, single-arm, open-label study with 20 acute basilar artery occlusion patients and premorbid modified Rankin Score (mRS) ≤3, treated with standard treatment (mechanical thrombectomy ± intravenous alteplase or conservative treatment) and Cerebrolysin as add-on therapy, compared with historical controls. Besides standard acute stroke assessment, standard treatment, and rehabilitation, the participants who meet the eligibility criteria will receive Cerebrolysin in a single-day dosage of 30 ml intravenously for 14 consecutive days. The participants will be closely monitored, and neuroimaging findings and clinical outcomes will be obtained during the drug administration period, on discharge, one month, and 3 months after the treatment onset.\n\nThe primary endpoints are mRS (0-3) on day 90 and mortality rate 90 days after the stroke onset. The secondary endpoints are defined as a change in any type of intracerebral bleeding and a change of min. 2 points on the National Institutes of Health Stroke Scale 24 hours, 14 days, 30 days, and 90 days post-stroke.\n\nThe investigators hypothesize that adding Cerebrolysin to standard stroke treatment will improve clinical outcomes and reduce morbidity and mortality in patients with acute basilar occlusion compared to standard treatment alone.",[62,63],"Basilar Artery Occlusion","Posterior Circulation Brain Infarction",[17,65,66,67,68],"neuroprotection","basilar artery occlusion","add-on therapy","posterior circulation stroke","NOT_YET_RECRUITING","2024-07-08",{"date":72,"type":73},"2024-07-09","ACTUAL",{"date":75,"type":56},"2024-07",{"date":77,"type":56},"2026-05",{"name":5,"class":6}]