None listed
Conditions
Interventions
This group will be treated with Albendazole, in 200 mg tablets, at a dose of 15 mg / kg / day, PO, BID + Praziquantel, in 600 mg tablets, at a dose of 50 mg / kg / day, PO, IDB
This group will be treated with Albendazole, in 200 mg tablets, at a dose of 15 mg / kg / day, PO, BID + Praziquantel Placebo, in tablets, PO, BID
This scheme will be administered for 10 days.
Sponsors
INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women between 16 and 65 years of age, with a diagnosis of viable cerebral parenchymal cysticercosis with 20 or fewer viable cysts detected by MRI and CT, and confirmed by Western Blot serology. 2. Patients with a diagnosis of epilepsy secondary to NCC and a history of one or more spontaneous seizures in the previous year and no more than 10 years. 3. Willingness to complete the minimum of two weeks of hospitalization required. 4. If the patient is a woman of childbearing age, negative urine tests and the willingness to use an adequate contraceptive method. 5. Normal values of hemoglobin, platelet count, white cell count, glucose and normal or decreased values of GOT, TGP, creatinine. 6. Negative PPD and, if positive, sputum results for TB, negative. 7. Negative stool test for Taenia eggs or Strongyloides larvae.
Exclusion criteria
Exclusion criteria: 1. Generalized Primary Epilepsy. 2. History of generalized epileptic status. 3. Type of NCC that exposes the patient to greater risks during the study. 4. Patients with persistent or progressive endocranial hypertension (HTE) or intracranial hypertension defined radiologically by CT or MRI. 5. Previous therapy with ABZ or PZQ in the last two years. 6. Pulmonary tuberculosis evidenced by chest x-ray and positive results of sputum, or signs compatible with tuberculosis infection. 7. Individuals with positive markers for active hepatitis. 8. Systemic disease distinct from NCC that may affect treatment or short-term prognosis. 9. Patients with unstable condition. 10. Pregnancy during the antiparasitic treatment. 11. History of hypersensitivity to ABZ or PZQ. 12. Simultaneous treatment with cimetidine or theophylline. 13. Chronic alcohol or drug abuse. 14. Inability or non-availability to perform a CT scan at the beginning of the study or an MRI at the sixth month. 15. Inability or non-availability of the subject or agent / legal representative in giving written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Cerebral nuclear magnetic resonance (NMR), with contrast. Measure:Proportion of parasites dying after a course with antiparasitic therapy. Timepoints:6 months after starting therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Absence of viable cysts or degeneration in the evaluation by contrasting MRI. The calcifications may be visible, but they are not defined as cystic structures. Criterion 2: Number of seizures (partial or with secondary generalization) during follow-up. Criterion 3: Determination of serum levels of ABZ sulfate (ABZSO4) and its correlation with brain MRI lesions. Criterion 4: Proportion of previous viable cysts that resolved and that are observed as radiological calcifications in the follow-up CT. Measure:1) Radiological cure. 2) Cumulative incidence of seizures. 3) Relationship between ABZSO4 levels and cysticide efficacy. 4) Proportion of calcified lesions. Timepoints:Criterion 1: At 6 months after treatment. Criterion 2: Follow-up at 18 months. Criterion 3: Days 4 and 7. Criterion 4: One year after treatment. ; Outcome name:Criterion 1: Clinical and imaging evaluation of CVD. Criterion 2: Determination of the number of patients dying from any cause. Criterion 3: Evaluation of neurological symptoms, such as seizures, intracranial hypertension and others. Measure:Complications of the disease: 1) Frequency of cerebrovascular disease. 2) Mortality in the first 18 months of follow-up. 3) Proportion of patients presenting neurological symptoms. Timepoints:When the event is presented. | — |
Countries
Peru
Outcome results
None listed