Oxfendazole in Mild Parenchymal Brain Cysticercosis

ConditionBrain Cysticercosis

Trial statusNot yet recruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorUniversidad Peruana Cayetano Heredia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female individuals between 18 and 75 years of age, with suspected viable or degenerating intraparenchymal brain cysticercosis on neuroimaging (CT or MRI) and fulfill the diagnostic criteria for solitary cysticercus granuloma (Rajshekhar and Chandy, 1997)

If female of child-bearing potential and men, willing to use an adequate method of contraception*, including implants, injectables, combined oral contraceptives, effective intrauterine devices, sexual abstinence, or vasectomized partner while participating in the study.

Patients with normal laboratory values for hemoglobin, platelet counts, total white blood cells, glucose, creatinine, bilirubin, ALT, and AST.

Availability to grant informed consent.

Disqualifiers

Multiple lesion sites or more than two adjacent lesions.

Suspected neurotuberculosis (Rajshekhar's criteria) [66,67]

More than two viable brain cysts.

Large brain cysts (> 3cm in diameter)

Trial design

Design model

Parallel

Treatments tested in this trial

Oxfendazole single dose
Drug
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
Drug
Subjects will receive active oxfendazole, 20 mg/kg/day, orally, in three days (1, 4 and 7)
albendazole plus praziquantel regime
Drug
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.

Treatment groups

544 Participants

are divided into 3 treatment groups

Group A: Intervention 1Experimental treatment 1 intervention

Group B: Intervention 2Experimental treatment 1 intervention

Group C: Comparison regimenActive comparator 1 intervention

Trial outcomes

Primary outcomes

Efficacy: completely resolution or persistence 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).

Time frame

Three months after treatment onset

Secondary outcomes

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

Time frame

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

Time frame

In the initial 12 months after treatment

Other outcomes

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.

Time frame

Month 3

Antiparasitic treatment type associated with gliosis or residual calcification.

Antiparasitic treatment type (oxfendazole single dose, or oxfendazole three doses, or combined albendazole plus praziquantel treatment) associated with focal gliosis or residual calcification.

Time frame

Month 6 and month 12

Antiparasitic treatment type associated with seizure relapses.

Antiparasitic treatment type (oxfendazole single dose, or oxfendazole three doses, or combined albendazole plus praziquantel treatment) associated with seizure relapses.

Time frame

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

Time frame

Before treatment and 12 months after antiparasitic treatment.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Peruana Cayetano Heredia

Lead sponsor

Oxfendazole Development Group

Collaborator

Source ClinicalTrials.gov

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