Status:
NOT_YET_RECRUITING
Oxfendazole in Mild Parenchymal Brain Cysticercosis
Lead Sponsor:
Universidad Peruana Cayetano Heredia
Collaborating Sponsors:
Oxfendazole Development Group
Conditions:
Brain Cysticercosis
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
PHASE3
Brief 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 cisticercosis....
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- Male or female individuals between 12 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 if you are over 18 years of age or assent if you are a minor between 12 and 17 years of age.
Exclusion
- 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)
- Subarachnoid neurocysticercosis or intraventricular
- Untreated ocular cysticercosis
- Previous therapy with ABZ (does not include patients who received single-dose 400 mg ABZ for intestinal parasites), or PZQ in the past twelve months.
- Active pulmonary tuberculosis evidenced by a positive chest X-ray and positive sputum smears.
- Systemic disease other than NCC that may affect therapy or short-term prognosis, including but not limited to chronic renal failure, hepatic insufficiency, cardiac failure, and steroid-dependent immune diseases.
- Patients in unstable condition or with severe intracranial hypertension (ICH). Definition of severe ICH for this study would be the presence of headaches, nausea, and vomiting, and papilledema at fundoscopic examination.
- Pregnancy
- History of hypersensitivity to ABZ or PZQ
- Concurrent treatment with cimetidine, ranitidine, or theophylline.
- Chronic alcohol or drug abuse
- Positive to Strongyloides infection
- History of reported allergy to contrast substances used in MRI.
Key Trial Info
Start Date :
December 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
544 Patients enrolled
Trial Details
Trial ID
NCT06565507
Start Date
December 15 2024
End Date
December 30 2028
Last Update
November 1 2024
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