B690 Cysticercosis of central nervous system Cysticercosis of central nervous system
Conditions
Interventions
OXF 20 mg/kg, single dose, orally - OXF 20 mg/kg, days 1, 4 y 7, orally ABZ (15 mg/kg/day for 10 days) + PZQ (50 mg/kg/day, for 10 days), orally
Sponsors
UNIVERSIDAD PERUANA CAYETANO HEREDIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 if you are over 18 years of age.
Exclusion criteria
Exclusion criteria: Multiple lesion sites or more than two adjacent lesions. Suspected neurotuberculosis (Rajshekhar’s criteria). 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI NAME OF THE RESULT: Proportion of participants whose lesions completely resolved or persist only as small lesion remnants (<20% of the original lesion size. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Three months after treatment onset | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life survey in epilepsy QOLIE-31 NAME OF THE RESULT: Factors associated with reduced quality of life before and after anti-parasitic treatment for mild parenchymal NCC PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Before treatment and 12 months after antiparasitic treatment.;Seizure diary, clinical evaluation NAME OF THE RESULT: The frequency of seizure relapses in individuals whose lesions resolved compared to those who had remaining viable or degenerating lesions on month 3 MRI. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: In the initial 12 months after treatment;MRI NAME OF THE RESULT: Proportion of participants whose lesions completely resolved or persist only as small lesion remnants (<20% of the original lesion size. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Three months after treatment onset;Clinical chart, adverse events and serious adverse event reports. NAME OF THE RESULT: Proportion of participants in each group who develop serious or severe adverse events, and the numbers of adverse events per group PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: In the initial 12 months after treatment;MRI NAME OF THE RESULT: Imaging characteristics on MRI at day 15 post treatment onset that are associated with successful lesion resolution on MRI. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Month 3;MRI (gliosis) CT (calcifications) NAME OF THE RESULT: Demographic, clinical, radiological, or therapeutic variables associated with focal gliosis or residual calcification. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Month 6 and month 12;Clinical chart, MRI NAME OF THE RESULT: Demographic, clinical, radiologica | — |
Countries
Peru
Outcome results
None listed