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Oxfendazole in Mild Parenchymal Brain Cysticercosis

NCT06565507 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2026-05-01

No results posted yet for this study

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 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.

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.

Conditions

  • Brain Cysticercosis

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.

Sponsors & Collaborators

  • Oxfendazole Development Group

    collaborator OTHER

  • Universidad Peruana Cayetano Heredia

    lead OTHER

Principal Investigators

  • Hector H Garcia, MD, PhD · Universidad Peruana Cayetano Heredia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2030-03-15
Completion
2030-12-15
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06565507 on ClinicalTrials.gov