deltatrials
Not Yet Recruiting INTERVENTIONAL 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

Sponsor: Oxfendazole Development Group

Updated 3 times since 2024 Last updated: Apr 27, 2026 Started: Dec 1, 2026 Primary completion: Mar 15, 2030 Completion: Dec 15, 2030
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Brain Cysticercosis, this trial is actively recruiting participants. The trial is conducted by Oxfendazole Development Group and has accumulated 3 data snapshots since 2026. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

This three-arm randomized controlled phase II/III clinical trial will compare the efficacy and safety of a single-dose regimen with 20 mg/kg oxfendazole and a regimen with three similar doses spread over seven days (day 1, day 4 and day 7), with the most effective antiparasitic regimen available, combined albendazole plus praziquantel for ten days in individuals with mild NCC (with one to two lesions). Participants will receive treatment with oxfendazole (one or three dose regimens) or the standard treatment (albendazole + praziquantel). At day 15 after treatment onset, an MRI will be performed to evaluate early predictors of lesion resolution. MRI at day 90 will serve to evaluate efficacy (lesion resolution) and a day 180 MRI will evaluate sequelae lesions. CT will be performed at the en of the study to confirm persistence of calcified sequelae lesion. The study will enroll 544 patients with viable or degenerating parenchymal NCC with no more than two lesions, all in a single brain area. Lesions can be one or two adjacent, viable or degenerating NCC lesions. Patients with only calcified lesions will not be included even if they show perilesional contrast enhancement.

This three-arm randomized controlled phase II/III clinical trial will compare the efficacy and safety of a single-dose regimen with 20 mg/kg oxfendazole and a regimen with three similar doses spread over seven days (day 1, day 4 and day 7), with the most effective antiparasitic regimen available, combined albendazole plus praziquantel for ten days in individuals with mild NCC (with one to two lesions).

Participants will receive treatment with oxfendazole (one or three dose regimens) or the standard treatment (albendazole + praziquantel). At day 15 after treatment onset, an MRI will be performed to evaluate early predictors of lesion resolution. MRI at day 90 will serve to evaluate efficacy (lesion resolution) and a day 180 MRI will evaluate sequelae lesions. CT will be performed at the en of the study to confirm persistence of calcified sequelae lesion.

The study will enroll 544 patients with viable or degenerating parenchymal NCC with no more than two lesions, all in a single brain area. Lesions can be one or two adjacent, viable or degenerating NCC lesions. Patients with only calcified lesions will not be included even if they show perilesional contrast enhancement.

Status Flow

~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshotNot Yet Recruiting~Dec 2024 – ~May 2026 · 17 months · monthly snapshotNot Yet RecruitingMay 4, 2026 – present · 2 months · daily APINot Yet Recruiting

Change History

3 versions recorded
  1. May 4, 2026 — Present [daily]

    Not Yet Recruiting

    Phase: PHASE2/PHASE3None

  2. Dec 2024 — May 2026 [monthly]

    Not Yet Recruiting PHASE2/PHASE3

  3. Sep 2024 — Dec 2024 [monthly]

    Not Yet Recruiting PHASE2/PHASE3

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • Oxfendazole Development Group
  • Universidad Peruana Cayetano Heredia
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.