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.

Condition	Treatment or Intervention
Epilepsy Cysticercosis	Drug: albendazole  Drug: dexamethasone  Drug: phenytoin

Further Study Details: 

Expected Total Enrollment:  120

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.

Ages Eligible for Study:  16 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

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

Study chairs or principal investigators

Robert H. Gilman,  Study Chair,  Johns Hopkins University   

Study ID Numbers:  199/13286; JHUSHPH-FDR001107
Record last reviewed:  January 2001
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004403
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08