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

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

Genetics Home Reference related topics:

pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics:

Epilepsy

ChemIDplus related topics:

Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Albendazole Phenytoin Phenytoin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

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

Study ID Numbers:	199/13286, JHUSHPH-FDR001107
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004403
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

Study placed in the following topic categories:

Dexamethasone

Seizures

Rare Diseases

Central Nervous System Diseases

Neurocysticercosis

Brain Diseases

Albendazole

Phenytoin

Central Nervous System Infections

Epilepsy

Mental Disorders

Cysticercosis

Taeniasis

Parasitic Diseases

Helminthiasis

Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Anti-Infective Agents

Antiprotozoal Agents

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Central Nervous System Helminthiasis

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics

Hormones

Central Nervous System Parasitic Infections

Antiparasitic Agents

Therapeutic Uses

Antineoplastic Agents, Hormonal

Antiplatyhelmintic Agents

Nervous System Diseases

Mitosis Modulators

Gastrointestinal Agents

Anthelmintics

Antimitotic Agents

Glucocorticoids

Pharmacologic Actions

Anticestodal Agents

Autonomic Agents

Tubulin Modulators

Cestode Infections

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 09, 2008

Sponsors and Collaborators:	FDA Office of Orphan Products Development Johns Hopkins University
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004403