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

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

May 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004403 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Epilepsy
Cysticercosis

Intervention ^ICMJE

Drug: albendazole
Drug: dexamethasone
Drug: phenytoin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

120

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004403

Responsible Party

Study ID Numbers ^ICMJE

199/13286, JHUSHPH-FDR001107

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

Johns Hopkins University

Investigators ^ICMJE

Study Chair:

Robert H. Gilman

Johns Hopkins University

Information Provided By

FDA Office of Orphan Products Development

Verification Date

January 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP