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NOT YET RECRUITING
NCT06565507
PHASE2/PHASE3

Oxfendazole in Mild Parenchymal Brain Cysticercosis

Sponsor: Universidad Peruana Cayetano Heredia

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

Oxfendazole three doses

Subjects will receive active oxfendazole, 20 mg/kg/day, orally, in three days (1, 4 and 7)

DRUG

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.