Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

NCT ID: NCT00004403

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-05-31
• Study Completion Date: 2002-03-31

Brief Summary

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

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

Epilepsy; Cysticercosis

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

albendazole

Intervention Type: DRUG

dexamethasone

Intervention Type: DRUG

phenytoin

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Principal Investigators

Robert H. Gilman

Role: STUDY_CHAIR

Johns Hopkins University

Other Identifiers

JHUSHPH-FDR001107

Identifier Type: -

Identifier Source: secondary_id

199/13286

Identifier Type: -

Identifier Source: org_study_id