Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

Official Title ^†

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Epilepsy
Cysticercosis

Intervention ^†

Drug: albendazole
Drug: dexamethasone
Drug: phenytoin

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

120

Start Date ^†

May 2000

Completion Date

Eligibility 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

Gender

Both

Ages

16 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00004403

Organization ID

199/13286

Secondary IDs ^††

JHUSHPH-FDR001107

Study Sponsor ^†

FDA Office of Orphan Products Development

Collaborators ^††

Johns Hopkins University

Investigators ^†

Study Chair:

Robert H. Gilman

Johns Hopkins University

Information Provided By

FDA Office of Orphan Products Development

Verification Date

January 2001

First Received Date ^†

October 18, 1999

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.