Oxfendazole in Mild Parenchymal Brain Cysticercosis
NCT Number: NCT06565507
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Brain Cysticercosis
Interventions: DRUG: Oxfendazole single dose|DRUG: Oxfendazole three doses|DRUG: albendazole plus praziquantel regime
Sponsor: Universidad Peruana Cayetano Heredia
Collaborators: Oxfendazole Development Group
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 544
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2028-12-30

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.

Primary Outcome Measures: Efficacy: completely resolution or persistance only as small lesion remnants., Proportion of participants whose lesions completely resolved or persist only as small lesion remnants (\<20% of the original lesion size)., Three months after treatment onset
Secondary Outcome Measures: Clinical effectiveness: Seizure relapses., The frequency of seizure relapses in individuals whose lesions resolved compared to those who had remaining viable or degenerating lesions on month 3 MRI, In the initial 12 months after treatment|Safety: Serious adverse events, Proportion of participants in each group who develop serious or severe adverse events, and the numbers of adverse events per group, In the initial 12 months after treatment
Other Outcome Measures: Early imaging markers predicting lesion resolution., Imaging characteristics on MRI at day 15 after treatment onset that are associated with successful lesion resolution on MRI., Month 3|Antiparasitic treatment type associated with gliosis or residual calcification., Antiparasitic treatment type (oxfendazole single dose, or oxfendazole three doses, or combined albendazol plus praziquantel treatment) associated with focal gliosis or residual calcification., Month 6 and month 12|Antiparasitic treatment type associated with seizure relapses., Antiparasitic treatment type (oxfendazole single dose, or oxfendazole three doses, or combined albendazol plus praziquantel treatment) associated with seizure relapses., During the initial 12 months after antiparasitic treatment.|Quality of life in Epilepsy (QOLIE-31) score around antiparasitic treatment in NCC, to assess emotional and psychological effects, and medical and social effects., Factors associated with reduced quality of life before and after anti-parasitic treatment for mild parenchymal NCC, Before treatment and 12 months after antiparasitic treatment.|Cysticercus size associated with seizure relapses., Measururement of cysticercus size, in millimeters, to evaluate its association with seizure relapses., During the initial 12 months after antiparasitic treatment.|Number of baseline seizures associated with seizure relapses., Number of pre-treatment seizures associated with seizure relapses after initiation of antiparasitic treatment., During the initial 12 months after antiparasitic treatment.|Cysticercus size associated with gliosis or residual calcification., Measururement of cysticercus size, in millimeters, to evaluate its association with gliosis or residual calcification., Month 6 and month 12