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
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
Treatments tested in this trial
- Oxfendazole single dose
- Oxfendazole three doses
- albendazole plus praziquantel regime
Treatment groups
544 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Universidad Peruana Cayetano Heredia
Lead sponsor
Oxfendazole Development Group
Collaborator
Source ClinicalTrials.gov