Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT00004403

Collaborator

(none)

120

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

OBJECTIVES: I. Determine the effect of antiparasitic treatment with albendazole on the severity and duration of epilepsy due to neurocysticercosis.

Determine the effect of a short course of albendazole on Taenia solium cysts present in the brain.
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 or Disease	Intervention/Treatment	Phase
Epilepsy Cysticercosis	Drug: albendazole Drug: dexamethasone Drug: phenytoin	N/A

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

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

May 1, 2000

Study Completion Date :

Mar 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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