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Oxfendazole in Mild Parenchymal Brain Cysticercosis
Sponsor: Universidad Peruana Cayetano Heredia
Summary
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 cisticercosis. 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. The 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.
Official title: 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
Key Details
Gender
All
Age Range
12 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
544
Start Date
2024-12-15
Completion Date
2028-12-30
Last Updated
2024-11-01
Healthy Volunteers
No
Conditions
Interventions
Oxfendazole single dose
Subjects will receive active oxfendazole, 20 mg/kg/day, orally, as a single dose. Oxfendazole placebo will be used at days 4 and 7 to maintain blinding between the two intervention arms.
Oxfendazole three doses
Subjects will receive active oxfendazole, 20 mg/kg/day, orally, in three days (1, 4 and 7)
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/kg/d and praziquantel at 50/kg/d.