Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2001 by FDA Office of Orphan Products Development. Recruitment status was Active, not recruiting

First Received on October 18, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	Johns Hopkins University
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004403

Purpose

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.

Condition	Intervention
Epilepsy Cysticercosis	Drug: albendazole Drug: dexamethasone Drug: phenytoin

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Dexamethasone Phenytoin Albendazole Dexamethasone acetate Doxiproct plus Phenytoin sodium Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	120
Study Start Date:	May 2000

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.

Eligibility

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004403

Sponsors and Collaborators

FDA Office of Orphan Products Development

Johns Hopkins University

Investigators

Study Chair:

Robert H. Gilman

Johns Hopkins University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004403 History of Changes
Other Study ID Numbers:	199/13286, JHUSHPH-FDR001107
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

cysticercosis
epilepsy
immunologic disorders and infectious disorders
neurologic and psychiatric disorders

parasitic infection
rare disease
seizures

Additional relevant MeSH terms:

Cysticercosis
Taeniasis
Neurocysticercosis
Epilepsy
Cestode Infections
Helminthiasis
Parasitic Diseases
Central Nervous System Helminthiasis
Central Nervous System Parasitic Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases
Albendazole
Phenytoin

Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on February 09, 2012