[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559544":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":42,"centralContacts":46,"locations":50,"responsibleParty":56,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":50,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":50,"studyType":74,"phases":75,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":84,"whyStopped":50,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":50},{"fullName":5,"class":6},"Universidad Peruana Cayetano Heredia","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention 1","EXPERIMENTAL","OXF 20 mg\u002Fkg\u002Fd, single dose, orally",[13],"Drug: Oxfendazole single dose",{"label":15,"type":10,"description":16,"interventionNames":17},"Intervention 2","OXF 20 mg\u002Fkg\u002Fd, for three days (1, 4 and 7), orally",[18],"Drug: Oxfendazole three doses",{"label":20,"type":21,"description":22,"interventionNames":23},"Comparison regimen","ACTIVE_COMPARATOR","Combined treatment with albendazole (15 mg\u002Fk\u002Fd) plus praziquantel (50 mg\u002Fk\u002Fd), for 10 days, orally.",[24],"Drug: albendazole plus praziquantel regime",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Oxfendazole single dose","Subjects will receive active oxfendazole, 20 mg\u002Fkg\u002Fday, orally, as a single dose. Oxfendazole placebo will be used at days 4 and 7 to maintain blinding between the two intervention arms.",[9],[9],{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Oxfendazole three doses","Subjects will receive active oxfendazole, 20 mg\u002Fkg\u002Fday, orally, in three days (1, 4 and 7)",[15],[15],{"type":27,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"albendazole plus praziquantel regime","Subjects will receive a combination of albendazole plus praziquantel, as a standard treatment for brain cysticercosis (neurocysticercosis), orally, for ten days. Albendazole will be given at 15\u002Fkg\u002Fd and praziquantel at 50\u002Fkg\u002Fd.",[20],[20],[43],{"name":44,"affiliation":5,"role":45},"Hector H Garcia, MD, PhD","PRINCIPAL_INVESTIGATOR",[47,52],{"name":44,"role":48,"phone":49,"phoneExt":50,"email":51},"CONTACT","+511 3287360",null,"hgarcia@jhsph.edu",{"name":53,"role":48,"phone":54,"phoneExt":50,"email":55},"Javier A Bustos, MD, PhD","+511 3284038","javier.bustos.p@upch.pe",{"type":57,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR",[59],{"name":60,"class":6},"Oxfendazole Development Group","100559544","phase-2-oxfendazole-in-mild-parenchymal-brain-cysticercosis-100559544",false,"NCT06565507","Oxfendazole in Mild Parenchymal Brain Cysticercosis","A Double-blind Multicenter, Randomized Controlled Trial of Single and Multiple Dose Regimens of Oxfendazole for Mild (One or Two Lesions) Parenchymal Brain Cysticercosis, With an Open Comparison Group","Inclusion Criteria:\n\n1. Male or female individuals between 18 and 75 years of age, with suspected viable or degenerating intraparenchymal brain cysticercosis on neuroimaging (CT or MRI) and fulfill the diagnostic criteria for solitary cysticercus granuloma (Rajshekhar and Chandy, 1997)\n2. If female of child-bearing potential and men, willing to use an adequate method of contraception\\*, including implants, injectables, combined oral contraceptives, effective intrauterine devices, sexual abstinence, or vasectomized partner while participating in the study.\n3. Patients with normal laboratory values for hemoglobin, platelet counts, total white blood cells, glucose, creatinine, bilirubin, ALT, and AST.\n4. Availability to grant informed consent.\n\nExclusion Criteria:\n\n1. Multiple lesion sites or more than two adjacent lesions.\n2. Suspected neurotuberculosis (Rajshekhar's criteria) \\[66,67\\]\n3. More than two viable brain cysts.\n4. Large brain cysts (\\> 3cm in diameter)\n5. Subarachnoid neurocysticercosis or intraventricular\n6. Untreated ocular cysticercosis\n7. Previous therapy with ABZ (does not include patients who received single-dose 400 mg ABZ for intestinal parasites), or PZQ in the past twelve months.\n8. Active pulmonary tuberculosis evidenced by a positive chest X-ray and positive sputum smears.\n9. Systemic disease other than NCC that may affect therapy or short-term prognosis, including but not limited to chronic renal failure, hepatic insufficiency, cardiac failure, and steroid-dependent immune diseases.\n10. Patients in unstable condition or with severe intracranial hypertension (ICH). Definition of severe ICH for this study would be the presence of headaches, nausea, and vomiting, and papilledema at fundoscopic examination.\n11. Pregnancy\n12. History of hypersensitivity to ABZ or PZQ\n13. Concurrent treatment with cimetidine, ranitidine, or theophylline.\n14. Chronic alcohol or drug abuse.\n15. Positive to Strongyloides infection\n16. History of reported allergy to contrast substances used in MRI.","ALL","18 Years","75 Years",{"count":72,"type":73},544,"ESTIMATED","INTERVENTIONAL",[76,77],"PHASE2","PHASE3","The goal of this clinical trial is to compare a single and multiple dose regimens of oxfendazole with the standard treatment in patients with mild (one or two lesions) parenchymal brain cysticercosis. The main question it aims to answer is if OXF will enhance clearance of brain parasites and therefore provide greater cysticidal efficacy, with the potential to provide a single-dose therapy for this type of NCC.\n\nThe study cohort will also allow us to identify early imaging markers that predict lesion resolution, as well as factors associated with residual calcification or focal gliosis after lesion resolution. This study will also provide additional information on the safety of the study interventions.",[80],"Brain Cysticercosis",[82,83],"Cysticercosis","Cysticercosis treatment","NOT_YET_RECRUITING","2026-04-27",{"date":87,"type":88},"2026-05-01","ACTUAL",{"date":90,"type":73},"2026-12-01",{"date":92,"type":73},"2030-12-15",{"name":5,"class":6}]