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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: albendazole
• Drug: dexamethasone
• Drug: phenytoin

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: FDA Office of Orphan Products Development

Overall Clinical Trial Officials and Contacts

Robert H. Gilman Study Chair Johns Hopkins University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00004403

Study ID Number: 199/13286

ClinicalTrials.gov Identifier: NCT00004403

Health Authority: United States: Federal Government