Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether a short course of increased corticosteroid dosing with tapered dosing decreases seizure frequency as compared to standard corticosteroid dosing in patients with neurocysticercosis (NCC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Albendazole; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Omeprazole

Criteria

Inclusion Criteria:

• Diagnosed with intraparenchymal NCC with 20 or fewer active cysts, as confirmed by enzyme-linked immunoelectrotransfer blot (EITB)

• Diagnosed with epilepsy secondary to NCC, with history of one or more spontaneous seizures within the 6 months prior to study entry

• Willingness to be hospitalized for a minimum of 2 weeks for this study

• PPD negative OR negative smears for tuberculosis (TB) if PPD positive

• Willing to use acceptable forms of contraception during the study and for at least 1 month after albendazole therapy

Exclusion Criteria:

• Primary generalized seizures not caused by NCC

• Subarachnoid or ventricular NCC

• Any vesicular lesion greater than 2 cm in diameter

• Previous therapy with albendazole or praziquantel within 2 years of study entry. Patients who have previously received single-dose albendazole for intestinal parasites are not excluded.

• Intracranial hypertension, as confirmed by CT or MRI

• History of status epilepticus

• Focal neurological defects

• Unstable or consistently abnormal vital signs (e.g., body temperature, pulse, respiratory rate, blood pressure)

• Cysts in critical regions, including brainstem or the eyes

• Pulmonary TB

• History of TB in the patient or history of TB in close contact of patient

• Chest x-ray suggestive of past or current TB

• Diabetes

• Systemic conditions (e.g., chronic kidney failure, liver disease, heart failure, steroid-dependent immune diseases) other than NCC that may interfere with the study

• Predicted survival time of less than 1 year

• Inability to undergo CT or MRI

• Hypersensitivity to albendazole, antiepileptic drugs, or contrast

• Hypertension at rest

• Require corticosteroids, received corticosteroids in the 4 weeks prior to study entry, or received corticosteroids for 9 or more days within the 6 months prior to study entry

• Other CNS processes that may interfere with study assessments

• Pregnancy or breastfeeding