Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

Study Overview
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Brief Summary
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OBJECTIVES: I. Determine the effect of antiparasitic treatment with albendazole on the severity and duration of epilepsy due to neurocysticercosis. II. Determine the effect of a short course of albendazole on Taenia solium cysts present in the brain. III. Determine the natural regression of cerebral T. solium cysts in patients given placebo and their response to treatment at the end of the study.

Detailed Description
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PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to receive either albendazole and dexamethasone or placebo. Patients receive phenytoin daily starting on day 1 and continuing until seizure free for 1 year. Albendazole and dexamethasone or placebo only is administered orally once daily on days 5-15. Patients are asked to maintain a diary. Patients are followed on day 15 and 30, then every 3 months for 3 years. Completion date provided represents the completion date of the grant per OOPD records

Conditions
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Epilepsy, Cysticercosis

Intervention / Treatment
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* Drug: albendazole
* Drug: dexamethasone
* Drug: phenytoin


Participation Criteria
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Eligibility Criteria
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PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Presence of Taenia solium infection as demonstrated by serology and head CT Head CT showing no more than 20 cysts At least 2 spontaneous seizures within the last 6 months excluding: Absence seizures Rolandic seizures Bilateral spike wave patterns compatible with genetic epilepsy --Prior/Concurrent Therapy-- No prior therapy for cysticercosis --Patient Characteristics-- Age: 16 to 65 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Neurologic: No focal deficits No motor deficits No cranial nerve lesions History of epilepsy of less than 5 years in duration No head CT evidence of the following: Arteriovenous malformations Trauma Cerebral infarcts or hemorrhages No other focal disease not attributable to cysticercosis No moderate or severe intracranial hypertension No status epilepticus Other: No unstable condition due to systemic disease or cysticercosis Not pregnant

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: albendazole|nan|
|Drug: dexamethasone|nan|
|Drug: phenytoin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cysticercosis, epilepsy, immunologic disorders and infectious disorders, neurologic and psychiatric disorders, parasitic infection, rare disease, seizures