None listed
Conditions
Interventions
This group will be treated with Albendazole 15 mg / kg / day VO BID (maximum dose 1200 mg) for 14 days. Dexamethasone 2 mg VO TID for 10 days, discontinuing without tapering.
Group name:ARM B Type of group
This group will be treated with Albendazole 15 mg / kg / day VO BID (maximum dose 1200 mg) for 14 days. Dexamethasone 8 mg VO divided into 3 doses every 8 hours for 4 weeks, with tapering of 4 days.
Sponsors
Instituto Nacional de Salud de los EE.UU (NIH-US),
Eligibility
Inclusion criteria
Inclusion criteria: 1) Diagnosis of intraparenchymal NCC with 1 to 20 viable cysts. 2) Positive serology for cysticercosis by means of the Western Blot test (EITB). 3) Adult male or female between 18-65 years of age. 4) Patients with a diagnosis of epilepsy secondary to NCC. 5) Willingness to be hospitalized for a minimum of two weeks and for a longer time should complications occur. 6) Normal laboratory values for the study population. 7) Absence of signs of intracranial hypertension. 8) Negative stool test for tapeworm eggs. 9) Measurement of PPD and if it is positive: serial sputum negative for TB. 10) Willingness to use a method for birth control.
Exclusion criteria
Exclusion criteria: 1) Primary generalized seizures. 2) Patients with subarachnoid or ventricular NGC. 3) Any vesicular lesion greater than 2 centimeters in diameter. 4) Previous therapy with ABZ or PZQ within the last 2 years. 5) Intracranial hypertension. 6) History of epileptic status. 7) Focal neurological deficits. 8) Unstable vital signs. 9) Cysts in critical regions including the mesencephalon and the eye. 10) Pulmonary tuberculosis. 11) History of TB in the patient or history of TB not treated in any close contact, with whom the participant was living. 12) Chest x-ray suggestive of past or present TB. 13) Diabetes pre-existing diagnosis. 14) Other systemic conditions that may affect the therapy or prognosis of NGC in the short term. 15) Participant who presents a concomitant disease that compromises their survival during the first year. 16) Pregnancy during treatment with ABZ. 17) No availability or inability to perform an MRI exam. 18) Unavailability or inability to perform a CT scan or MRI at the beginning of the study at 6 months, a CT scan at the end of the study or after delivery if the participant was pregnant. 19) History of hypersensitivity to ABZ, antiepileptic drugs or contrast material. 20) Breastfeeding during treatment. 21) Hypertension at rest. 22) Patient is currently receiving corticosteroids, which has received this treatment within the last 4 weeks. 23) Other CNS processes that may be confused with changes in CNS function due to cysticercosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation. Measure:Cumulative frequency of partial, generalized seizures and total seizure frequency between days 11 and 42. Timepoints:Days 1, 7, 10, 14, 21, 28, 30, 32, 34, 36, 38, 42. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation. Brain CT or MRI. The resonance will minimally include a coronal, axial and sagittal image in T1 and in the FLAIR sequence. Measure:Cumulative frequency of partial, generalized seizures and total seizure frequency between days 43 and 90 and between days 90 and 360. Proportion of seizure-free patients between days 90 and 360. Proportion of patients free of viable cysts between days 180 and 360. Proportion of patients with viable cysts between days 180 and 360. Proportion of patients who required a second antiparasitic treatment. Timepoints:Clinical evaluation: Days 1, 7, 10, 14, 21, 28, 30, 32, 34, 36, 38, 42, 60, 90, 180, 270, 360. CT or MRI: At the beginning of the study and on days 180 and 360. ; Outcome name:Clinical evaluation. Hematology panel. Panel of serum chemistry. Measure:Safety of treatment: Adverse effects of albendazole, dexamethasone, phenytoin. Laboratory exams. Timepoints:Clinical evaluation: Days: 7, 10, 14, 21, 28, 30, 32, 34, 36, 38, 42, 60, 90, 180, 270, 360. Laboratory tests: Day 1, 10, 14, 21, 28, 34, 42, 60. | — |
Countries
Peru
Outcome results
None listed