MedPath

Oxfendazole in Mild Parenchymal Brain Cysticercosis

Phase 2
Not yet recruiting
Conditions
Brain Cysticercosis
Registration Number
NCT06565507
Lead Sponsor
Universidad Peruana Cayetano Heredia
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not yet recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Inclusion Criteria:<br><br> 1. Male or female individuals between 12 and 75 years of age, with suspected viable or<br> degenerating intraparenchymal brain cysticercosis on neuroimaging (CT or MRI) and<br> fulfill the diagnostic criteria for solitary cysticercus granuloma (Rajshekhar and<br> Chandy, 1997)<br><br> 2. If female of child-bearing potential and men, willing to use an adequate method of<br> contraception*, including implants, injectables, combined oral contraceptives,<br> effective intrauterine devices, sexual abstinence, or vasectomized partner while<br> participating in the study.<br><br> 3. Patients with normal laboratory values for hemoglobin, platelet counts, total white<br> blood cells, glucose, creatinine, bilirubin, ALT, and AST.<br><br> 4. Availability to grant informed consent if you are over 18 years of age or assent if<br> you are a minor between 12 and 17 years of age.<br><br>Exclusion Criteria:<br><br> 1. Multiple lesion sites or more than two adjacent lesions.<br><br> 2. Suspected neurotuberculosis (Rajshekhar's criteria) [66,67]<br><br> 3. More than two viable brain cysts.<br><br> 4. Large brain cysts (> 3cm in diameter)<br><br> 5. Subarachnoid neurocysticercosis or intraventricular<br><br> 6. Untreated ocular cysticercosis<br><br> 7. Previous therapy with ABZ (does not include patients who received single-dose 400 mg<br> ABZ for intestinal parasites), or PZQ in the past twelve months.<br><br> 8. Active pulmonary tuberculosis evidenced by a positive chest X-ray and positive<br> sputum smears.<br><br> 9. Systemic disease other than NCC that may affect therapy or short-term prognosis,<br> including but not limited to chronic renal failure, hepatic insufficiency, cardiac<br> failure, and steroid-dependent immune diseases.<br><br> 10. Patients in unstable condition or with severe intracranial hypertension (ICH).<br> Definition of severe ICH for this study would be the presence of headaches, nausea,<br> and vomiting, and papilledema at fundoscopic examination.<br><br> 11. Pregnancy<br><br> 12. History of hypersensitivity to ABZ or PZQ<br><br> 13. Concurrent treatment with cimetidine, ranitidine, or theophylline.<br><br> 14. Chronic alcohol or drug abuse<br><br> 15. Positive to Strongyloides infection<br><br> 16. History of reported allergy to contrast substances used in MRI.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Efficacy: completely resolution or persistance only as small lesion remnants.
Secondary Outcome Measures
NameTimeMethod
Clinical effectiveness: Seizure relapses.;Safety: Serious adverse events
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